Women's Health

Use of a digital step counter improved mobility in women at high risk for thromboembolic events after a cesarean delivery, based on data from a randomized trial of 215 patients.

“Patient immobility after surgery is associated with an increased risk of VTE [venous thromboembolism], whereas adequate mobility offers the benefits of enhanced bowel movement resumption and decreasing hospitalization length,” wrote Hadas Ganer Herman, MD, of Tel Aviv University, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 108 women to a personalized feedback program using pedometers to promote mobility after cesarean delivery; 107 served as controls. Patient demographics and intrapartum experiences, including age, body mass index, and gestation week at delivery, were similar between the groups, as were postpartum complications and the use of analgesics.

Patients who used the pedometers took significantly more steps, compared with controls (5,918 vs. 4,161, P < .001). In addition, women in the pedometer group reported improved physical and mental postpartum recovery and higher levels of satisfaction with their delivery experience, the researchers noted.

The study findings were limited by several factors including potential selection bias among patients who completed the full follow-up, as well as the effect of preset visits from the research team during the study and lack of blinding of the participants. In addition, data on thromboembolic events after hospital discharge were available only through patient phone calls, the researchers noted.

“Our trial is notable for its novelty in exploring an intervention to improve postcesarean delivery mobility, using an objective means of digital step counters,” and for focusing on high-risk patients of clinical interest, Dr. Herman and associates wrote.

Larger studies are needed to explore interventions to improve mobility after cesarean deliveries, they emphasized. However, “because the integration between technology and medicine has continued to evolve and has successfully been proven for additional patient care issues in obstetrics, the current trial offers a basis for interpretation, with the possible use of low-cost interventions such as smart phone applications in maternity wards and simple digital feedback.”

“VTEs are still among the leading causes of maternal morbidity and mortality with peak incidence in the immediate postpartum period,” Martina L. Badell, MD, of Emory University, Atlanta, said in an interview. “As the age and body mass index of our pregnant patients continues to increase, focused attention to prevent VTEs in high-risk populations is very important.”

Dr. Badell said that pedometers are a feasible strategy “provided there is funding available to pay for and provide them.” Pedometers “don’t cause pain/discomfort and can be easily worn and reused. If the hospital isn’t able to provide them, however, then cost could be a barrier to high-risk women using pedometers in the immediate postpartum period.”

“The take-home message is that wearing a pedometer is a simple, low-risk strategy to encourage increased ambulation in a high-risk postpartum population with good patient satisfaction,” Dr. Badell said. The next step for research in this area “is to determine how many steps during the immediate postpartum period is optimal to reduce not only VTE risk, but potentially other postoperative markers such as pain and infection,” she added. Another research question is whether “focused feedback-based pedometers during the prolonged postpartum period result in improved weight loss.”

The researchers had no relevant financial disclosures. Dr. Badell said she had no relevant financial disclosures.

SOURCE: Herman HG et al. Obstet Gynecol. 2020 May 7. doi: 10.1097/AOG.0000000000003879.

Use of a digital step counter improved mobility in women at high risk for thromboembolic events after a cesarean delivery, based on data from a randomized trial of 215 patients.

“Patient immobility after surgery is associated with an increased risk of VTE [venous thromboembolism], whereas adequate mobility offers the benefits of enhanced bowel movement resumption and decreasing hospitalization length,” wrote Hadas Ganer Herman, MD, of Tel Aviv University, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 108 women to a personalized feedback program using pedometers to promote mobility after cesarean delivery; 107 served as controls. Patient demographics and intrapartum experiences, including age, body mass index, and gestation week at delivery, were similar between the groups, as were postpartum complications and the use of analgesics.

Patients who used the pedometers took significantly more steps, compared with controls (5,918 vs. 4,161, P < .001). In addition, women in the pedometer group reported improved physical and mental postpartum recovery and higher levels of satisfaction with their delivery experience, the researchers noted.

The study findings were limited by several factors including potential selection bias among patients who completed the full follow-up, as well as the effect of preset visits from the research team during the study and lack of blinding of the participants. In addition, data on thromboembolic events after hospital discharge were available only through patient phone calls, the researchers noted.

“Our trial is notable for its novelty in exploring an intervention to improve postcesarean delivery mobility, using an objective means of digital step counters,” and for focusing on high-risk patients of clinical interest, Dr. Herman and associates wrote.

Larger studies are needed to explore interventions to improve mobility after cesarean deliveries, they emphasized. However, “because the integration between technology and medicine has continued to evolve and has successfully been proven for additional patient care issues in obstetrics, the current trial offers a basis for interpretation, with the possible use of low-cost interventions such as smart phone applications in maternity wards and simple digital feedback.”

“VTEs are still among the leading causes of maternal morbidity and mortality with peak incidence in the immediate postpartum period,” Martina L. Badell, MD, of Emory University, Atlanta, said in an interview. “As the age and body mass index of our pregnant patients continues to increase, focused attention to prevent VTEs in high-risk populations is very important.”

Dr. Badell said that pedometers are a feasible strategy “provided there is funding available to pay for and provide them.” Pedometers “don’t cause pain/discomfort and can be easily worn and reused. If the hospital isn’t able to provide them, however, then cost could be a barrier to high-risk women using pedometers in the immediate postpartum period.”

“The take-home message is that wearing a pedometer is a simple, low-risk strategy to encourage increased ambulation in a high-risk postpartum population with good patient satisfaction,” Dr. Badell said. The next step for research in this area “is to determine how many steps during the immediate postpartum period is optimal to reduce not only VTE risk, but potentially other postoperative markers such as pain and infection,” she added. Another research question is whether “focused feedback-based pedometers during the prolonged postpartum period result in improved weight loss.”

The researchers had no relevant financial disclosures. Dr. Badell said she had no relevant financial disclosures.

SOURCE: Herman HG et al. Obstet Gynecol. 2020 May 7. doi: 10.1097/AOG.0000000000003879.

Use of a digital step counter improved mobility in women at high risk for thromboembolic events after a cesarean delivery, based on data from a randomized trial of 215 patients.

“Patient immobility after surgery is associated with an increased risk of VTE [venous thromboembolism], whereas adequate mobility offers the benefits of enhanced bowel movement resumption and decreasing hospitalization length,” wrote Hadas Ganer Herman, MD, of Tel Aviv University, and colleagues.

In a study published in Obstetrics & Gynecology, the researchers randomized 108 women to a personalized feedback program using pedometers to promote mobility after cesarean delivery; 107 served as controls. Patient demographics and intrapartum experiences, including age, body mass index, and gestation week at delivery, were similar between the groups, as were postpartum complications and the use of analgesics.

Patients who used the pedometers took significantly more steps, compared with controls (5,918 vs. 4,161, P < .001). In addition, women in the pedometer group reported improved physical and mental postpartum recovery and higher levels of satisfaction with their delivery experience, the researchers noted.

The study findings were limited by several factors including potential selection bias among patients who completed the full follow-up, as well as the effect of preset visits from the research team during the study and lack of blinding of the participants. In addition, data on thromboembolic events after hospital discharge were available only through patient phone calls, the researchers noted.

“Our trial is notable for its novelty in exploring an intervention to improve postcesarean delivery mobility, using an objective means of digital step counters,” and for focusing on high-risk patients of clinical interest, Dr. Herman and associates wrote.

Larger studies are needed to explore interventions to improve mobility after cesarean deliveries, they emphasized. However, “because the integration between technology and medicine has continued to evolve and has successfully been proven for additional patient care issues in obstetrics, the current trial offers a basis for interpretation, with the possible use of low-cost interventions such as smart phone applications in maternity wards and simple digital feedback.”

“VTEs are still among the leading causes of maternal morbidity and mortality with peak incidence in the immediate postpartum period,” Martina L. Badell, MD, of Emory University, Atlanta, said in an interview. “As the age and body mass index of our pregnant patients continues to increase, focused attention to prevent VTEs in high-risk populations is very important.”

Dr. Badell said that pedometers are a feasible strategy “provided there is funding available to pay for and provide them.” Pedometers “don’t cause pain/discomfort and can be easily worn and reused. If the hospital isn’t able to provide them, however, then cost could be a barrier to high-risk women using pedometers in the immediate postpartum period.”

“The take-home message is that wearing a pedometer is a simple, low-risk strategy to encourage increased ambulation in a high-risk postpartum population with good patient satisfaction,” Dr. Badell said. The next step for research in this area “is to determine how many steps during the immediate postpartum period is optimal to reduce not only VTE risk, but potentially other postoperative markers such as pain and infection,” she added. Another research question is whether “focused feedback-based pedometers during the prolonged postpartum period result in improved weight loss.”

The researchers had no relevant financial disclosures. Dr. Badell said she had no relevant financial disclosures.

SOURCE: Herman HG et al. Obstet Gynecol. 2020 May 7. doi: 10.1097/AOG.0000000000003879.

Combination therapy with relugolix, an investigational oral gonadotropin-releasing hormone antagonist, estradiol, and norethindrone acetate effectively preserved bone mineral density (BMD) in two replicate phase 3 studies enrolling women with heavy menstrual bleeding associated with uterine fibroids.

The BMD findings, released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, build upon previously reported positive primary endpoint data from the LIBERTY 1 and LIBERTY 2 studies. ACOG canceled the meeting and released abstracts for press coverage.

The developer of the drug, Myovant Sciences, plans to submit a new drug application to the Food and Drug Administration for approval of the single-tablet combination therapy for women with uterine fibroids, according to Albert Liao, the company’s director of corporate communications.

The two multinational LIBERTY studies randomized women who had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles (or 160 mL in one cycle) in a 1:1:1 ratio to one of three groups: relugolix combination therapy for 24 weeks (once-daily relugolix 40 mg plus estradiol 1.0 mg plus norethindrone acetate 0.5 mg); relugolix alone (40 mg once daily) for 12 weeks followed by relugolix combination therapy for 12 weeks; or placebo for 24 weeks.

In October 2019 at the American Society for Reproductive Medicine Scientific Congress, investigators reported that 73% of women receiving combination therapy in the LIBERTY 1 trial achieved a menstrual blood loss of less than 80 mL and a 50% or greater reduction from baseline over the last 35 days of treatment, compared with 19% in the placebo group. The mean percent reduction in menstrual blood loss from baseline at week 24 was 84% for combination therapy and 23% for placebo.

Earlier in 2019, Myovant Sciences announced that, in the LIBERTY 2 study, 71% of women receiving combination therapy met the primary endpoints, compared with 15% in the placebo group. The reduction in menstrual blood loss in this study’s combination therapy arm was also 84%, according to a company press release from June 2019.

Each of the two clinical trials enrolled upwards of 380 women.

The new abstract released for press coverage by ACOG and published in Obstetrics & Gynecology reports that women receiving relugolix combination therapy in the LIBERTY 1 and LIBERTY 2 studies had a mean change in lumbar spine BMD of –0.36% and –0.13%, respectively, from baseline to 24 weeks. Percent change in lumbar spine BMD in the delayed combination therapy groups (12 initial weeks of relugolix monotherapy) was –1.82% and –2.12%. In the placebo groups, the change was 0.05% and 0.32%.

Michael R. McClung, MD, who is the lead author of the abstract and was scheduled to present the findings at the ACOG meeting, said in an interview that the slight decreases in lumbar spine BMD with combination therapy were noted largely at week 12 and are “clinically insignificant in my opinion.” BMD by dual-energy x-ray absorptiometry was assessed at weeks 12 and 24.

“There was no further increase [after week 12] and [in some patients] there was even a return to baseline,” said Dr. McClung, of the Oregon Osteoporosis Center in Portland.

The safety and efficacy of longer-term treatment with relugolix combination therapy has been investigated thus far through an open-label extension study that brought the treatment period to 52 weeks. The 1-year data has been positive and will be presented or published soon, said Mr. Liao. In addition, a “second, 52-week randomized withdrawal study has been designed to provide 2-year safety and efficacy data … and to evaluate the need for maintenance therapy.”

It’s important, Dr. McClung said, “for clinicians to be confident that BMD loss is prevented or minimized with longer-term relugolix combination therapy since treatment for uterine fibroids is not a short-term proposition. Given the stability of BMD values between weeks 12 and 24 in the LIBERTY studies, I’d anticipate that we will see stable values with longer-term treatment.”

Dr. McClung disclosed that he has served as a consultant/advisory board member and speaker for Amgen and a consultant/advisory board member for Myovant. Several of his coauthors disclosed employment and ownerships interests in Myovant.

SOURCE: McClung MR et al. Obstet Gynecol. 2020 May. doi: 10.1097/01.AOG.0000662944.34860.b4.

Combination therapy with relugolix, an investigational oral gonadotropin-releasing hormone antagonist, estradiol, and norethindrone acetate effectively preserved bone mineral density (BMD) in two replicate phase 3 studies enrolling women with heavy menstrual bleeding associated with uterine fibroids.

The BMD findings, released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, build upon previously reported positive primary endpoint data from the LIBERTY 1 and LIBERTY 2 studies. ACOG canceled the meeting and released abstracts for press coverage.

The developer of the drug, Myovant Sciences, plans to submit a new drug application to the Food and Drug Administration for approval of the single-tablet combination therapy for women with uterine fibroids, according to Albert Liao, the company’s director of corporate communications.

The two multinational LIBERTY studies randomized women who had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles (or 160 mL in one cycle) in a 1:1:1 ratio to one of three groups: relugolix combination therapy for 24 weeks (once-daily relugolix 40 mg plus estradiol 1.0 mg plus norethindrone acetate 0.5 mg); relugolix alone (40 mg once daily) for 12 weeks followed by relugolix combination therapy for 12 weeks; or placebo for 24 weeks.

In October 2019 at the American Society for Reproductive Medicine Scientific Congress, investigators reported that 73% of women receiving combination therapy in the LIBERTY 1 trial achieved a menstrual blood loss of less than 80 mL and a 50% or greater reduction from baseline over the last 35 days of treatment, compared with 19% in the placebo group. The mean percent reduction in menstrual blood loss from baseline at week 24 was 84% for combination therapy and 23% for placebo.

Earlier in 2019, Myovant Sciences announced that, in the LIBERTY 2 study, 71% of women receiving combination therapy met the primary endpoints, compared with 15% in the placebo group. The reduction in menstrual blood loss in this study’s combination therapy arm was also 84%, according to a company press release from June 2019.

Each of the two clinical trials enrolled upwards of 380 women.

The new abstract released for press coverage by ACOG and published in Obstetrics & Gynecology reports that women receiving relugolix combination therapy in the LIBERTY 1 and LIBERTY 2 studies had a mean change in lumbar spine BMD of –0.36% and –0.13%, respectively, from baseline to 24 weeks. Percent change in lumbar spine BMD in the delayed combination therapy groups (12 initial weeks of relugolix monotherapy) was –1.82% and –2.12%. In the placebo groups, the change was 0.05% and 0.32%.

Michael R. McClung, MD, who is the lead author of the abstract and was scheduled to present the findings at the ACOG meeting, said in an interview that the slight decreases in lumbar spine BMD with combination therapy were noted largely at week 12 and are “clinically insignificant in my opinion.” BMD by dual-energy x-ray absorptiometry was assessed at weeks 12 and 24.

“There was no further increase [after week 12] and [in some patients] there was even a return to baseline,” said Dr. McClung, of the Oregon Osteoporosis Center in Portland.

The safety and efficacy of longer-term treatment with relugolix combination therapy has been investigated thus far through an open-label extension study that brought the treatment period to 52 weeks. The 1-year data has been positive and will be presented or published soon, said Mr. Liao. In addition, a “second, 52-week randomized withdrawal study has been designed to provide 2-year safety and efficacy data … and to evaluate the need for maintenance therapy.”

It’s important, Dr. McClung said, “for clinicians to be confident that BMD loss is prevented or minimized with longer-term relugolix combination therapy since treatment for uterine fibroids is not a short-term proposition. Given the stability of BMD values between weeks 12 and 24 in the LIBERTY studies, I’d anticipate that we will see stable values with longer-term treatment.”

Dr. McClung disclosed that he has served as a consultant/advisory board member and speaker for Amgen and a consultant/advisory board member for Myovant. Several of his coauthors disclosed employment and ownerships interests in Myovant.

SOURCE: McClung MR et al. Obstet Gynecol. 2020 May. doi: 10.1097/01.AOG.0000662944.34860.b4.

Combination therapy with relugolix, an investigational oral gonadotropin-releasing hormone antagonist, estradiol, and norethindrone acetate effectively preserved bone mineral density (BMD) in two replicate phase 3 studies enrolling women with heavy menstrual bleeding associated with uterine fibroids.

The BMD findings, released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, build upon previously reported positive primary endpoint data from the LIBERTY 1 and LIBERTY 2 studies. ACOG canceled the meeting and released abstracts for press coverage.

The developer of the drug, Myovant Sciences, plans to submit a new drug application to the Food and Drug Administration for approval of the single-tablet combination therapy for women with uterine fibroids, according to Albert Liao, the company’s director of corporate communications.

The two multinational LIBERTY studies randomized women who had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles (or 160 mL in one cycle) in a 1:1:1 ratio to one of three groups: relugolix combination therapy for 24 weeks (once-daily relugolix 40 mg plus estradiol 1.0 mg plus norethindrone acetate 0.5 mg); relugolix alone (40 mg once daily) for 12 weeks followed by relugolix combination therapy for 12 weeks; or placebo for 24 weeks.

In October 2019 at the American Society for Reproductive Medicine Scientific Congress, investigators reported that 73% of women receiving combination therapy in the LIBERTY 1 trial achieved a menstrual blood loss of less than 80 mL and a 50% or greater reduction from baseline over the last 35 days of treatment, compared with 19% in the placebo group. The mean percent reduction in menstrual blood loss from baseline at week 24 was 84% for combination therapy and 23% for placebo.

Earlier in 2019, Myovant Sciences announced that, in the LIBERTY 2 study, 71% of women receiving combination therapy met the primary endpoints, compared with 15% in the placebo group. The reduction in menstrual blood loss in this study’s combination therapy arm was also 84%, according to a company press release from June 2019.

Each of the two clinical trials enrolled upwards of 380 women.

The new abstract released for press coverage by ACOG and published in Obstetrics & Gynecology reports that women receiving relugolix combination therapy in the LIBERTY 1 and LIBERTY 2 studies had a mean change in lumbar spine BMD of –0.36% and –0.13%, respectively, from baseline to 24 weeks. Percent change in lumbar spine BMD in the delayed combination therapy groups (12 initial weeks of relugolix monotherapy) was –1.82% and –2.12%. In the placebo groups, the change was 0.05% and 0.32%.

Michael R. McClung, MD, who is the lead author of the abstract and was scheduled to present the findings at the ACOG meeting, said in an interview that the slight decreases in lumbar spine BMD with combination therapy were noted largely at week 12 and are “clinically insignificant in my opinion.” BMD by dual-energy x-ray absorptiometry was assessed at weeks 12 and 24.

“There was no further increase [after week 12] and [in some patients] there was even a return to baseline,” said Dr. McClung, of the Oregon Osteoporosis Center in Portland.

The safety and efficacy of longer-term treatment with relugolix combination therapy has been investigated thus far through an open-label extension study that brought the treatment period to 52 weeks. The 1-year data has been positive and will be presented or published soon, said Mr. Liao. In addition, a “second, 52-week randomized withdrawal study has been designed to provide 2-year safety and efficacy data … and to evaluate the need for maintenance therapy.”

It’s important, Dr. McClung said, “for clinicians to be confident that BMD loss is prevented or minimized with longer-term relugolix combination therapy since treatment for uterine fibroids is not a short-term proposition. Given the stability of BMD values between weeks 12 and 24 in the LIBERTY studies, I’d anticipate that we will see stable values with longer-term treatment.”

Dr. McClung disclosed that he has served as a consultant/advisory board member and speaker for Amgen and a consultant/advisory board member for Myovant. Several of his coauthors disclosed employment and ownerships interests in Myovant.

SOURCE: McClung MR et al. Obstet Gynecol. 2020 May. doi: 10.1097/01.AOG.0000662944.34860.b4.

Use of testicular sperm in nonazoospermic couples who had prior in vitro fertilization failure using ejaculated sperm appears to improve embryo development and rates of clinical pregnancy and live birth, a retrospective observational study has found.

©ktsimage/iStockphoto.com

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

The study, which won the college’s Donald F. Richardson Memorial Prize Research Paper award, evaluated 112 nonazoospermic couples with an average of 2.3 failed in vitro fertilization (IVF) cycles (range of 1-8). The couples, patients at Shade Grove Fertility in Washington, underwent 157 total intracytoplasmic sperm injection (ICSI) cycles (133 using fresh testicular sperm and 24 using frozen/thawed sperm) and had a total of 101 embryo transfers.

Use of ICSI with testicular sperm compared with prior cycles using ejaculated sperm significantly improved blastocyst development (65% vs. 33%, P < .001), blastocyst conversion rates (67% vs. 35%, P < .001) and the number of embryos available for vitrification (1.6 vs. 0.7, P < .001). Fertilization rates were similar (70% vs. 58%). The clinical pregnancy and live birth rates in couples who used testicular sperm were 44% and 32%, respectively.

The findings suggest improved embryo development and pregnancy rates, and offer more evidence “that this might be something we can offer patients who’ve had multiple failures and no other reason as to why,” M. Blake Evans, DO, clinical fellow in reproductive endocrinology and infertility at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md., said in a interview. “It looks like there is promise, and we need more research to be conducted.”

The integration of the use of testicular sperm at Shady Grove, a private practice fertility center, and the newly completed analysis of outcomes, were driven by studies “showing that testicular sperm has a low DNA fragmentation index and suggesting that it [offers a] better chance of successful IVF outcomes in patients who have had prior failures,” he said.

Almost all of the men who had ICSC using testicular sperm – 105 of the 112 – had a sperm DNA fragmentation (SDF) assessment of their ejaculate sperm. The mean SDF was 32% and of these 105 men, 66 had an SDF greater than 25% (mean of 49%), a value considered abnormal. The outcomes for patients with elevated SDF did not differ significantly from the overall cohort, Dr. Evans and coinvestigators reported in their abstract.

Dr. Evans said that it’s too early to draw any conclusions about the utility of SDF testing, and that the investigators plan to start prospectively evaluating whether levels of sperm DNA damage as reflected in SDF testing correlate with IVF outcomes.

“Right now the evidence is so conflicting as to whether [SDF testing offers] information that all IVF patients or infertility patients should be receiving,” he said. “Is the reason that testicular sperm works better because there’s lower DNA fragmentation? We think so. … But now that we see [that it] appears the outcomes are better [using testicular sperm], we need to take it a step further and look prospectively at the impact of DNA fragmentation, comparing all the outcomes with normal and abnormal DNA [levels].”

Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview that while “there is increasing evidence – and rather clear evidence – that testicular sperm has less DNA damage,” there has been controversy over available outcomes data, most of which have come from small, retrospective studies. Dr. Trolice was not involved in this study presented at ACOG.

In the case of “very poor outcomes with use of ejaculated sperm and a high SDF index, there seems to be support for the use of testicular sperm on the next IVF cycle,” he said. “But there’s also evidence to support that there’s no significant difference in the outcomes of IUI [intrauterine insemination] or IVF based on the SDF index. So this [study] really took a tremendous leap of faith.”

Dr. Trolice said he looks forward to more research – ideally prospective, randomized studies of men with high SDF levels who proceed with assisted reproductive technologies using ejaculated or testicular sperm.

The research was supported by the division of intramural research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Evans did not report any relevant financial disclosures. One of his coinvestigators. Micah J. Hill, DO, disclosed having served on the advisory board of Ohana Biosciences. Dr. Trolice reported that he has no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.

The abstract was first presented by coauthor Lt. Allison A. Eubanks, MD, of Walter Reed National Military Medical Center, at the ACOG Armed Forces District Annual District Meeting in September 2019.

pdnews@mdedge.com

Use of testicular sperm in nonazoospermic couples who had prior in vitro fertilization failure using ejaculated sperm appears to improve embryo development and rates of clinical pregnancy and live birth, a retrospective observational study has found.

©ktsimage/iStockphoto.com

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

The study, which won the college’s Donald F. Richardson Memorial Prize Research Paper award, evaluated 112 nonazoospermic couples with an average of 2.3 failed in vitro fertilization (IVF) cycles (range of 1-8). The couples, patients at Shade Grove Fertility in Washington, underwent 157 total intracytoplasmic sperm injection (ICSI) cycles (133 using fresh testicular sperm and 24 using frozen/thawed sperm) and had a total of 101 embryo transfers.

Use of ICSI with testicular sperm compared with prior cycles using ejaculated sperm significantly improved blastocyst development (65% vs. 33%, P < .001), blastocyst conversion rates (67% vs. 35%, P < .001) and the number of embryos available for vitrification (1.6 vs. 0.7, P < .001). Fertilization rates were similar (70% vs. 58%). The clinical pregnancy and live birth rates in couples who used testicular sperm were 44% and 32%, respectively.

The findings suggest improved embryo development and pregnancy rates, and offer more evidence “that this might be something we can offer patients who’ve had multiple failures and no other reason as to why,” M. Blake Evans, DO, clinical fellow in reproductive endocrinology and infertility at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md., said in a interview. “It looks like there is promise, and we need more research to be conducted.”

The integration of the use of testicular sperm at Shady Grove, a private practice fertility center, and the newly completed analysis of outcomes, were driven by studies “showing that testicular sperm has a low DNA fragmentation index and suggesting that it [offers a] better chance of successful IVF outcomes in patients who have had prior failures,” he said.

Almost all of the men who had ICSC using testicular sperm – 105 of the 112 – had a sperm DNA fragmentation (SDF) assessment of their ejaculate sperm. The mean SDF was 32% and of these 105 men, 66 had an SDF greater than 25% (mean of 49%), a value considered abnormal. The outcomes for patients with elevated SDF did not differ significantly from the overall cohort, Dr. Evans and coinvestigators reported in their abstract.

Dr. Evans said that it’s too early to draw any conclusions about the utility of SDF testing, and that the investigators plan to start prospectively evaluating whether levels of sperm DNA damage as reflected in SDF testing correlate with IVF outcomes.

“Right now the evidence is so conflicting as to whether [SDF testing offers] information that all IVF patients or infertility patients should be receiving,” he said. “Is the reason that testicular sperm works better because there’s lower DNA fragmentation? We think so. … But now that we see [that it] appears the outcomes are better [using testicular sperm], we need to take it a step further and look prospectively at the impact of DNA fragmentation, comparing all the outcomes with normal and abnormal DNA [levels].”

Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview that while “there is increasing evidence – and rather clear evidence – that testicular sperm has less DNA damage,” there has been controversy over available outcomes data, most of which have come from small, retrospective studies. Dr. Trolice was not involved in this study presented at ACOG.

In the case of “very poor outcomes with use of ejaculated sperm and a high SDF index, there seems to be support for the use of testicular sperm on the next IVF cycle,” he said. “But there’s also evidence to support that there’s no significant difference in the outcomes of IUI [intrauterine insemination] or IVF based on the SDF index. So this [study] really took a tremendous leap of faith.”

Dr. Trolice said he looks forward to more research – ideally prospective, randomized studies of men with high SDF levels who proceed with assisted reproductive technologies using ejaculated or testicular sperm.

The research was supported by the division of intramural research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Evans did not report any relevant financial disclosures. One of his coinvestigators. Micah J. Hill, DO, disclosed having served on the advisory board of Ohana Biosciences. Dr. Trolice reported that he has no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.

The abstract was first presented by coauthor Lt. Allison A. Eubanks, MD, of Walter Reed National Military Medical Center, at the ACOG Armed Forces District Annual District Meeting in September 2019.

pdnews@mdedge.com

Use of testicular sperm in nonazoospermic couples who had prior in vitro fertilization failure using ejaculated sperm appears to improve embryo development and rates of clinical pregnancy and live birth, a retrospective observational study has found.

©ktsimage/iStockphoto.com

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

The study, which won the college’s Donald F. Richardson Memorial Prize Research Paper award, evaluated 112 nonazoospermic couples with an average of 2.3 failed in vitro fertilization (IVF) cycles (range of 1-8). The couples, patients at Shade Grove Fertility in Washington, underwent 157 total intracytoplasmic sperm injection (ICSI) cycles (133 using fresh testicular sperm and 24 using frozen/thawed sperm) and had a total of 101 embryo transfers.

Use of ICSI with testicular sperm compared with prior cycles using ejaculated sperm significantly improved blastocyst development (65% vs. 33%, P < .001), blastocyst conversion rates (67% vs. 35%, P < .001) and the number of embryos available for vitrification (1.6 vs. 0.7, P < .001). Fertilization rates were similar (70% vs. 58%). The clinical pregnancy and live birth rates in couples who used testicular sperm were 44% and 32%, respectively.

The findings suggest improved embryo development and pregnancy rates, and offer more evidence “that this might be something we can offer patients who’ve had multiple failures and no other reason as to why,” M. Blake Evans, DO, clinical fellow in reproductive endocrinology and infertility at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md., said in a interview. “It looks like there is promise, and we need more research to be conducted.”

The integration of the use of testicular sperm at Shady Grove, a private practice fertility center, and the newly completed analysis of outcomes, were driven by studies “showing that testicular sperm has a low DNA fragmentation index and suggesting that it [offers a] better chance of successful IVF outcomes in patients who have had prior failures,” he said.

Almost all of the men who had ICSC using testicular sperm – 105 of the 112 – had a sperm DNA fragmentation (SDF) assessment of their ejaculate sperm. The mean SDF was 32% and of these 105 men, 66 had an SDF greater than 25% (mean of 49%), a value considered abnormal. The outcomes for patients with elevated SDF did not differ significantly from the overall cohort, Dr. Evans and coinvestigators reported in their abstract.

Dr. Evans said that it’s too early to draw any conclusions about the utility of SDF testing, and that the investigators plan to start prospectively evaluating whether levels of sperm DNA damage as reflected in SDF testing correlate with IVF outcomes.

“Right now the evidence is so conflicting as to whether [SDF testing offers] information that all IVF patients or infertility patients should be receiving,” he said. “Is the reason that testicular sperm works better because there’s lower DNA fragmentation? We think so. … But now that we see [that it] appears the outcomes are better [using testicular sperm], we need to take it a step further and look prospectively at the impact of DNA fragmentation, comparing all the outcomes with normal and abnormal DNA [levels].”

Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview that while “there is increasing evidence – and rather clear evidence – that testicular sperm has less DNA damage,” there has been controversy over available outcomes data, most of which have come from small, retrospective studies. Dr. Trolice was not involved in this study presented at ACOG.

In the case of “very poor outcomes with use of ejaculated sperm and a high SDF index, there seems to be support for the use of testicular sperm on the next IVF cycle,” he said. “But there’s also evidence to support that there’s no significant difference in the outcomes of IUI [intrauterine insemination] or IVF based on the SDF index. So this [study] really took a tremendous leap of faith.”

Dr. Trolice said he looks forward to more research – ideally prospective, randomized studies of men with high SDF levels who proceed with assisted reproductive technologies using ejaculated or testicular sperm.

The research was supported by the division of intramural research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Evans did not report any relevant financial disclosures. One of his coinvestigators. Micah J. Hill, DO, disclosed having served on the advisory board of Ohana Biosciences. Dr. Trolice reported that he has no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.

The abstract was first presented by coauthor Lt. Allison A. Eubanks, MD, of Walter Reed National Military Medical Center, at the ACOG Armed Forces District Annual District Meeting in September 2019.

pdnews@mdedge.com

Mental illnesses are associated with a significantly increased risk of subsequent physical diseases, new research shows.

An international team of researchers has created an “atlas” that maps the relationship between specific mental disorders and the risk of subsequent physical illnesses.

The researchers found that, following the diagnosis of a mental disorder, psychiatric patients are significantly more likely than the general population to develop potentially life-threatening conditions, including heart disease and stroke.

These findings, the investigators noted, highlight the need for better medical care in this vulnerable population. They have created a website with detailed information about the risks of specific physical ailments and the link to particular mental disorders.

“We found that women with anxiety disorders have a 50% increased risk of developing a heart condition or stroke – over 15 years, one in three women with anxiety disorders will develop these medical disorders,” lead investigator John McGrath, MD, PhD, University of Queensland’s Brain Institute, Brisbane, Australia, and Aarhus (Denmark) University, said in a statement.

“We also looked at men with substance use disorders such as alcohol-related disorders and found they have a 400% increased risk of gut or liver disorders, while over 15 years, one in five of them will develop gut or liver conditions,” he added.

The study was published in the New England Journal of Medicine.
 

New ‘atlas’

It’s well known that patients with mental disorders have decreased quality of life, increased health care utilization, and a shorter life expectancy than individuals in the general population – about 10 years for men and 7 years for women.

However, the investigators noted, previous research examining the relationship between mental disorders and medical conditions only focused on “particular pairs or a small set of mental disorders and medical conditions.”

“We needed a comprehensive study to map the links between different types of mental disorders versus different types of general medical conditions. Our study has provided this atlas,” Dr. McGrath said in an interview.

The clinical utility of such a map could provide comprehensive data on relative and absolute risks of various medical conditions after a diagnosis of a mental disorder. This information, the researchers noted, would “help clinicians and health care planners identify the primary prevention needs of their patients.”

The study included 5.9 million people born in Denmark between 1900 and 2015 and followed them from 2000 to 2016, a total of 83.9 million person-years. The researchers followed patients for up to 17 years (2000-2016) for medical diagnoses and up to 48 years (1969-2016) for diagnoses of mental disorders.

The study’s large sample size allowed investigators to assess 10 broad types of mental disorders and 9 broad categories of medical conditions that encompassed 31 specific conditions.

Categories of medical conditions included circulatory, endocrine, pulmonary, gastrointestinal, urogenital, musculoskeletal, hematologic, neurologic, and cancer. Mental disorder categories included organic disorders such as Alzheimer’s, substance abuse disorders, schizophrenia, mood disorders, neurotic disorders, eating disorders, personality disorders, developmental disorders, behavioral/emotional disorders, and intellectual disabilities.

The researchers estimated associations between 90 pairs of mental disorders and broad-category medical conditions, as well as 310 pairs of mental disorders and specific medical conditions.
 

‘Curious’ finding

Individuals with mental disorders showed a higher risk of medical conditions in 76 out of 90 specific mental disorder–medical condition pairs.

After adjusting for sex, age, calendar time, and previous coexisting mental disorders, the median hazard ratio for a subsequent medical condition was 1.37 in patients with a mental disorder.

The lowest HR was 0.82 for organic mental disorders and the broad category of cancer (95% confidence interval, 0.80-0.84), and the highest was 3.62 for eating disorders and urogenital conditions (95% CI, 3.11-4.22). On the other hand, schizophrenia was associated with a reduced risk of developing musculoskeletal conditions (HR, 0.87; 95% CI, 0.84-0.91).

Dr. McGrath described this finding as “curious” and speculated it “may be related to underlying genetic risk factors.”

One of the highest cumulative associations was for mood disorders and circulatory conditions during the first 15 years following a mood disorder diagnosis, compared with the matched reference group without a mood disorder (40.9% vs. 32.6%, respectively).

The risk of developing subsequent medical conditions after a mental disorder diagnosis did not remain steady over time. For instance, although mood disorders were associated with an increased risk of developing circulatory problems (HR, 1.32; 95% CI, 1.31-1.34), the highest risk occurred during the first 6 months following diagnosis and gradually decreased over the next 15 years (HR, 2.39; 95% CI, 2.29-2.48 and HR, 1.18; 95% CI, 1.17-1.20, respectively).

“Many people with mental disorders have unhealthy lifestyle, including low exercise, poor diet, smoking, and alcohol, which may account for the increased risk of physical illness, and also they may not seek and/or may not get quick treatment for their health conditions,” said Dr. McGrath.

Additionally, “perhaps some genetic and early life exposures, such as trauma, may increase the risk of both medical conditions and mental disorders,” he added. “We need better treatments for mental disorders, so that they do not slip into unemployment or poverty.”
 

A strong case

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto and head of the mood disorders psychopharmacology unit, University Health Network, said that the research “really makes a strong case for the fact that persons who have mental disorders are at higher risk of chronic diseases, and it’s the chronic diseases that decrease their lifespan.”

Dr. McIntyre, who is also director of the Depression and Bipolar Support Alliance, said that the “takeaway message is that mental disorders are not just brain disorders but are multisystem disorders.”

For this reason, “the most appropriate way to provide care would be to provide a holistic approach to treat and prevent the chronic diseases that lead to increase in mortality,” recommended Dr. McIntyre, who was not involved with the current study.

The study was supported by grants from the Danish National Research Foundation, the National Health and Medical Research Council, the Novo Nordisk Foundation , the European Union’s Horizon 2020 Research and Innovation Program, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the European Commission, Helsefonden, the Danish Council for Independent Research, the Independent Research Fund Denmark, the National Health and Medical Research Council of Australia, and the National Institute on Drug Abuse.

Dr. McGrath has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reports receiving grants from Stanley Medical Research Institute; the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation; and receiving speaking/consultation fees from Lundbeck, Janssen, Shire, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, and Minerva.

A version of this article originally appeared on Medscape.com.

Mental illnesses are associated with a significantly increased risk of subsequent physical diseases, new research shows.

An international team of researchers has created an “atlas” that maps the relationship between specific mental disorders and the risk of subsequent physical illnesses.

The researchers found that, following the diagnosis of a mental disorder, psychiatric patients are significantly more likely than the general population to develop potentially life-threatening conditions, including heart disease and stroke.

These findings, the investigators noted, highlight the need for better medical care in this vulnerable population. They have created a website with detailed information about the risks of specific physical ailments and the link to particular mental disorders.

“We found that women with anxiety disorders have a 50% increased risk of developing a heart condition or stroke – over 15 years, one in three women with anxiety disorders will develop these medical disorders,” lead investigator John McGrath, MD, PhD, University of Queensland’s Brain Institute, Brisbane, Australia, and Aarhus (Denmark) University, said in a statement.

“We also looked at men with substance use disorders such as alcohol-related disorders and found they have a 400% increased risk of gut or liver disorders, while over 15 years, one in five of them will develop gut or liver conditions,” he added.

The study was published in the New England Journal of Medicine.
 

New ‘atlas’

It’s well known that patients with mental disorders have decreased quality of life, increased health care utilization, and a shorter life expectancy than individuals in the general population – about 10 years for men and 7 years for women.

However, the investigators noted, previous research examining the relationship between mental disorders and medical conditions only focused on “particular pairs or a small set of mental disorders and medical conditions.”

“We needed a comprehensive study to map the links between different types of mental disorders versus different types of general medical conditions. Our study has provided this atlas,” Dr. McGrath said in an interview.

The clinical utility of such a map could provide comprehensive data on relative and absolute risks of various medical conditions after a diagnosis of a mental disorder. This information, the researchers noted, would “help clinicians and health care planners identify the primary prevention needs of their patients.”

The study included 5.9 million people born in Denmark between 1900 and 2015 and followed them from 2000 to 2016, a total of 83.9 million person-years. The researchers followed patients for up to 17 years (2000-2016) for medical diagnoses and up to 48 years (1969-2016) for diagnoses of mental disorders.

The study’s large sample size allowed investigators to assess 10 broad types of mental disorders and 9 broad categories of medical conditions that encompassed 31 specific conditions.

Categories of medical conditions included circulatory, endocrine, pulmonary, gastrointestinal, urogenital, musculoskeletal, hematologic, neurologic, and cancer. Mental disorder categories included organic disorders such as Alzheimer’s, substance abuse disorders, schizophrenia, mood disorders, neurotic disorders, eating disorders, personality disorders, developmental disorders, behavioral/emotional disorders, and intellectual disabilities.

The researchers estimated associations between 90 pairs of mental disorders and broad-category medical conditions, as well as 310 pairs of mental disorders and specific medical conditions.
 

‘Curious’ finding

Individuals with mental disorders showed a higher risk of medical conditions in 76 out of 90 specific mental disorder–medical condition pairs.

After adjusting for sex, age, calendar time, and previous coexisting mental disorders, the median hazard ratio for a subsequent medical condition was 1.37 in patients with a mental disorder.

The lowest HR was 0.82 for organic mental disorders and the broad category of cancer (95% confidence interval, 0.80-0.84), and the highest was 3.62 for eating disorders and urogenital conditions (95% CI, 3.11-4.22). On the other hand, schizophrenia was associated with a reduced risk of developing musculoskeletal conditions (HR, 0.87; 95% CI, 0.84-0.91).

Dr. McGrath described this finding as “curious” and speculated it “may be related to underlying genetic risk factors.”

One of the highest cumulative associations was for mood disorders and circulatory conditions during the first 15 years following a mood disorder diagnosis, compared with the matched reference group without a mood disorder (40.9% vs. 32.6%, respectively).

The risk of developing subsequent medical conditions after a mental disorder diagnosis did not remain steady over time. For instance, although mood disorders were associated with an increased risk of developing circulatory problems (HR, 1.32; 95% CI, 1.31-1.34), the highest risk occurred during the first 6 months following diagnosis and gradually decreased over the next 15 years (HR, 2.39; 95% CI, 2.29-2.48 and HR, 1.18; 95% CI, 1.17-1.20, respectively).

“Many people with mental disorders have unhealthy lifestyle, including low exercise, poor diet, smoking, and alcohol, which may account for the increased risk of physical illness, and also they may not seek and/or may not get quick treatment for their health conditions,” said Dr. McGrath.

Additionally, “perhaps some genetic and early life exposures, such as trauma, may increase the risk of both medical conditions and mental disorders,” he added. “We need better treatments for mental disorders, so that they do not slip into unemployment or poverty.”
 

A strong case

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto and head of the mood disorders psychopharmacology unit, University Health Network, said that the research “really makes a strong case for the fact that persons who have mental disorders are at higher risk of chronic diseases, and it’s the chronic diseases that decrease their lifespan.”

Dr. McIntyre, who is also director of the Depression and Bipolar Support Alliance, said that the “takeaway message is that mental disorders are not just brain disorders but are multisystem disorders.”

For this reason, “the most appropriate way to provide care would be to provide a holistic approach to treat and prevent the chronic diseases that lead to increase in mortality,” recommended Dr. McIntyre, who was not involved with the current study.

The study was supported by grants from the Danish National Research Foundation, the National Health and Medical Research Council, the Novo Nordisk Foundation , the European Union’s Horizon 2020 Research and Innovation Program, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the European Commission, Helsefonden, the Danish Council for Independent Research, the Independent Research Fund Denmark, the National Health and Medical Research Council of Australia, and the National Institute on Drug Abuse.

Dr. McGrath has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reports receiving grants from Stanley Medical Research Institute; the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation; and receiving speaking/consultation fees from Lundbeck, Janssen, Shire, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, and Minerva.

A version of this article originally appeared on Medscape.com.

Mental illnesses are associated with a significantly increased risk of subsequent physical diseases, new research shows.

An international team of researchers has created an “atlas” that maps the relationship between specific mental disorders and the risk of subsequent physical illnesses.

The researchers found that, following the diagnosis of a mental disorder, psychiatric patients are significantly more likely than the general population to develop potentially life-threatening conditions, including heart disease and stroke.

These findings, the investigators noted, highlight the need for better medical care in this vulnerable population. They have created a website with detailed information about the risks of specific physical ailments and the link to particular mental disorders.

“We found that women with anxiety disorders have a 50% increased risk of developing a heart condition or stroke – over 15 years, one in three women with anxiety disorders will develop these medical disorders,” lead investigator John McGrath, MD, PhD, University of Queensland’s Brain Institute, Brisbane, Australia, and Aarhus (Denmark) University, said in a statement.

“We also looked at men with substance use disorders such as alcohol-related disorders and found they have a 400% increased risk of gut or liver disorders, while over 15 years, one in five of them will develop gut or liver conditions,” he added.

The study was published in the New England Journal of Medicine.
 

New ‘atlas’

It’s well known that patients with mental disorders have decreased quality of life, increased health care utilization, and a shorter life expectancy than individuals in the general population – about 10 years for men and 7 years for women.

However, the investigators noted, previous research examining the relationship between mental disorders and medical conditions only focused on “particular pairs or a small set of mental disorders and medical conditions.”

“We needed a comprehensive study to map the links between different types of mental disorders versus different types of general medical conditions. Our study has provided this atlas,” Dr. McGrath said in an interview.

The clinical utility of such a map could provide comprehensive data on relative and absolute risks of various medical conditions after a diagnosis of a mental disorder. This information, the researchers noted, would “help clinicians and health care planners identify the primary prevention needs of their patients.”

The study included 5.9 million people born in Denmark between 1900 and 2015 and followed them from 2000 to 2016, a total of 83.9 million person-years. The researchers followed patients for up to 17 years (2000-2016) for medical diagnoses and up to 48 years (1969-2016) for diagnoses of mental disorders.

The study’s large sample size allowed investigators to assess 10 broad types of mental disorders and 9 broad categories of medical conditions that encompassed 31 specific conditions.

Categories of medical conditions included circulatory, endocrine, pulmonary, gastrointestinal, urogenital, musculoskeletal, hematologic, neurologic, and cancer. Mental disorder categories included organic disorders such as Alzheimer’s, substance abuse disorders, schizophrenia, mood disorders, neurotic disorders, eating disorders, personality disorders, developmental disorders, behavioral/emotional disorders, and intellectual disabilities.

The researchers estimated associations between 90 pairs of mental disorders and broad-category medical conditions, as well as 310 pairs of mental disorders and specific medical conditions.
 

‘Curious’ finding

Individuals with mental disorders showed a higher risk of medical conditions in 76 out of 90 specific mental disorder–medical condition pairs.

After adjusting for sex, age, calendar time, and previous coexisting mental disorders, the median hazard ratio for a subsequent medical condition was 1.37 in patients with a mental disorder.

The lowest HR was 0.82 for organic mental disorders and the broad category of cancer (95% confidence interval, 0.80-0.84), and the highest was 3.62 for eating disorders and urogenital conditions (95% CI, 3.11-4.22). On the other hand, schizophrenia was associated with a reduced risk of developing musculoskeletal conditions (HR, 0.87; 95% CI, 0.84-0.91).

Dr. McGrath described this finding as “curious” and speculated it “may be related to underlying genetic risk factors.”

One of the highest cumulative associations was for mood disorders and circulatory conditions during the first 15 years following a mood disorder diagnosis, compared with the matched reference group without a mood disorder (40.9% vs. 32.6%, respectively).

The risk of developing subsequent medical conditions after a mental disorder diagnosis did not remain steady over time. For instance, although mood disorders were associated with an increased risk of developing circulatory problems (HR, 1.32; 95% CI, 1.31-1.34), the highest risk occurred during the first 6 months following diagnosis and gradually decreased over the next 15 years (HR, 2.39; 95% CI, 2.29-2.48 and HR, 1.18; 95% CI, 1.17-1.20, respectively).

“Many people with mental disorders have unhealthy lifestyle, including low exercise, poor diet, smoking, and alcohol, which may account for the increased risk of physical illness, and also they may not seek and/or may not get quick treatment for their health conditions,” said Dr. McGrath.

Additionally, “perhaps some genetic and early life exposures, such as trauma, may increase the risk of both medical conditions and mental disorders,” he added. “We need better treatments for mental disorders, so that they do not slip into unemployment or poverty.”
 

A strong case

In a comment, Roger McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto and head of the mood disorders psychopharmacology unit, University Health Network, said that the research “really makes a strong case for the fact that persons who have mental disorders are at higher risk of chronic diseases, and it’s the chronic diseases that decrease their lifespan.”

Dr. McIntyre, who is also director of the Depression and Bipolar Support Alliance, said that the “takeaway message is that mental disorders are not just brain disorders but are multisystem disorders.”

For this reason, “the most appropriate way to provide care would be to provide a holistic approach to treat and prevent the chronic diseases that lead to increase in mortality,” recommended Dr. McIntyre, who was not involved with the current study.

The study was supported by grants from the Danish National Research Foundation, the National Health and Medical Research Council, the Novo Nordisk Foundation , the European Union’s Horizon 2020 Research and Innovation Program, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the European Commission, Helsefonden, the Danish Council for Independent Research, the Independent Research Fund Denmark, the National Health and Medical Research Council of Australia, and the National Institute on Drug Abuse.

Dr. McGrath has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reports receiving grants from Stanley Medical Research Institute; the Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/Chinese National Natural Research Foundation; and receiving speaking/consultation fees from Lundbeck, Janssen, Shire, Purdue, Pfizer, Otsuka, Allergan, Takeda, Neurocrine, Sunovion, and Minerva.

A version of this article originally appeared on Medscape.com.

ILLUSTRATIVE CASE

A 27-year-old G1P000 at term with an uncomplicated pregnancy has been laboring for 6 hours with an epidural in place and a reassuring fetal heart tracing. She is at –2 station with complete cervical dilation and effacement. Should she push now or delay pushing to allow for more descent?

More than 10,000 women give birth each day in the United States, yet few of our approaches to labor management are evidence based.² For example, there are no clear guidelines on whether immediate pushing or delayed pushing (waiting 1-2 hours) in the second stage of labor (the time from complete cervical dilation to delivery of the fetus) leads to better outcomes.

A recent Cochrane review, which included very low- to moderate-quality trials of nulliparous and multiparous women using epidural analgesia showed that delayed pushing resulted in more vaginal deliveries, longer duration of second stage of labor, and shorter duration of pushing.³ But many of the trials included in this Cochrane review were noted to have study design limitations and significant heterogeneity.

A recent retrospective study found that delayed pushing resulted in longer duration of pushing and increased risks for cesarean section, operative vaginal delivery, and postpartum hemorrhage in nulliparous patients with and without epidurals.⁴ The World Health Organization recommends delayed pushing in women with epidural analgesia if time and fetal monitoring resources are available.⁵

STUDY SUMMARY

Does the timing of second stage pushing efforts affect outcomes?

This multicenter randomized controlled trial (RCT) evaluated the effect on spontaneous vaginal delivery of delayed pushing vs immediate pushing in 2404 term nulliparous women using epidural analgesia.¹ Patients were ≥ 37 weeks’ gestation. Once patients achieved 10 cm of cervical dilation, they were randomized in a 1:1 ratio to either immediate pushing or to delayed (for 60 minutes) pushing (unless there was an irresistible urge to push or they were otherwise instructed by their provider).

Outcome and results. The primary outcome was spontaneous vaginal delivery without the use of any operative support. The mean time to pushing after complete cervical dilation was 19 minutes in the immediate pushing group and 60 minutes in the delayed group. There was no difference in the rate of spontaneous vaginal delivery between the immediate and delayed pushing groups (86% vs 87%, respectively; P = .67). The immediate pushing group had a shorter duration of second stage of labor (102 minutes vs 134 minutes; mean difference [MD] = –32 minutes; 95% confidence interval [CI], –37 to –27; P < .001) and a slightly longer duration of active pushing (84 minutes vs 75 minutes; MD = 9.2 minutes; 95% CI, 6-13; P < .001).

Delaying pushing once the cervix is completely dilated is not indicated, even for nulliparous women receiving epidural analgesia.

There was no significant difference in operative vaginal or cesarean deliveries. Postpartum hemorrhage was lower in the immediate pushing group (2.3% vs 4%; risk ratio [RR] = 0.6; 95% CI, 0.3-0.9; P = .03; number needed to treat [NNT] = 58), as was chorioamnionitis (6.7% vs 9.1%; RR = 0.7; 95% CI, 0.66-0.90; P = .005; NNT = 40). There was no significant difference in neonatal morbidity between groups. And in subgroup analysis, there was no significant difference in rates of vaginal delivery based on fetal position (occiput anterior, posterior, or transverse) or station (defined as high [< 2 cm] or low [≥ 2 cm]) between groups. Recruitment was stopped early at 75% because there was no difference in the primary outcome and there was concern regarding an increased risk of hemorrhage in the delayed pushing group.

Continue to: WHAT'S NEW

WHAT’S NEW

There’s no good reason to delay pushing

Delaying pushing once the cervix is completely dilated is not indicated, even for nulliparous women receiving epidural analgesia, as it does not decrease the rate of spontaneous vaginal delivery. It does, however, increase the length of second stage labor and the risk of postpartum hemorrhage and chorioamnionitis.

CAVEATS

Study was stopped early, and groups were unblinded

This study was stopped early, so it is not known if it was underpowered for some of the secondary outcomes. Also, it was not possible to blind the groups, so it is not clear if any bias in patient management or diagnosis resulted.

CHALLENGES TO IMPLEMENTATION

Will current practice and culture pose obstacles?

Although the overt challenges to enacting a policy of immediate pushing are minimal, the inertia of current practice and culture could affect the implementation of this strategy.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 27-year-old G1P000 at term with an uncomplicated pregnancy has been laboring for 6 hours with an epidural in place and a reassuring fetal heart tracing. She is at –2 station with complete cervical dilation and effacement. Should she push now or delay pushing to allow for more descent?

More than 10,000 women give birth each day in the United States, yet few of our approaches to labor management are evidence based.² For example, there are no clear guidelines on whether immediate pushing or delayed pushing (waiting 1-2 hours) in the second stage of labor (the time from complete cervical dilation to delivery of the fetus) leads to better outcomes.

A recent Cochrane review, which included very low- to moderate-quality trials of nulliparous and multiparous women using epidural analgesia showed that delayed pushing resulted in more vaginal deliveries, longer duration of second stage of labor, and shorter duration of pushing.³ But many of the trials included in this Cochrane review were noted to have study design limitations and significant heterogeneity.

A recent retrospective study found that delayed pushing resulted in longer duration of pushing and increased risks for cesarean section, operative vaginal delivery, and postpartum hemorrhage in nulliparous patients with and without epidurals.⁴ The World Health Organization recommends delayed pushing in women with epidural analgesia if time and fetal monitoring resources are available.⁵

STUDY SUMMARY

Does the timing of second stage pushing efforts affect outcomes?

This multicenter randomized controlled trial (RCT) evaluated the effect on spontaneous vaginal delivery of delayed pushing vs immediate pushing in 2404 term nulliparous women using epidural analgesia.¹ Patients were ≥ 37 weeks’ gestation. Once patients achieved 10 cm of cervical dilation, they were randomized in a 1:1 ratio to either immediate pushing or to delayed (for 60 minutes) pushing (unless there was an irresistible urge to push or they were otherwise instructed by their provider).

Outcome and results. The primary outcome was spontaneous vaginal delivery without the use of any operative support. The mean time to pushing after complete cervical dilation was 19 minutes in the immediate pushing group and 60 minutes in the delayed group. There was no difference in the rate of spontaneous vaginal delivery between the immediate and delayed pushing groups (86% vs 87%, respectively; P = .67). The immediate pushing group had a shorter duration of second stage of labor (102 minutes vs 134 minutes; mean difference [MD] = –32 minutes; 95% confidence interval [CI], –37 to –27; P < .001) and a slightly longer duration of active pushing (84 minutes vs 75 minutes; MD = 9.2 minutes; 95% CI, 6-13; P < .001).

Delaying pushing once the cervix is completely dilated is not indicated, even for nulliparous women receiving epidural analgesia.

There was no significant difference in operative vaginal or cesarean deliveries. Postpartum hemorrhage was lower in the immediate pushing group (2.3% vs 4%; risk ratio [RR] = 0.6; 95% CI, 0.3-0.9; P = .03; number needed to treat [NNT] = 58), as was chorioamnionitis (6.7% vs 9.1%; RR = 0.7; 95% CI, 0.66-0.90; P = .005; NNT = 40). There was no significant difference in neonatal morbidity between groups. And in subgroup analysis, there was no significant difference in rates of vaginal delivery based on fetal position (occiput anterior, posterior, or transverse) or station (defined as high [< 2 cm] or low [≥ 2 cm]) between groups. Recruitment was stopped early at 75% because there was no difference in the primary outcome and there was concern regarding an increased risk of hemorrhage in the delayed pushing group.

Continue to: WHAT'S NEW

WHAT’S NEW

There’s no good reason to delay pushing

Delaying pushing once the cervix is completely dilated is not indicated, even for nulliparous women receiving epidural analgesia, as it does not decrease the rate of spontaneous vaginal delivery. It does, however, increase the length of second stage labor and the risk of postpartum hemorrhage and chorioamnionitis.

CAVEATS

Study was stopped early, and groups were unblinded

This study was stopped early, so it is not known if it was underpowered for some of the secondary outcomes. Also, it was not possible to blind the groups, so it is not clear if any bias in patient management or diagnosis resulted.

CHALLENGES TO IMPLEMENTATION

Will current practice and culture pose obstacles?

Although the overt challenges to enacting a policy of immediate pushing are minimal, the inertia of current practice and culture could affect the implementation of this strategy.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 27-year-old G1P000 at term with an uncomplicated pregnancy has been laboring for 6 hours with an epidural in place and a reassuring fetal heart tracing. She is at –2 station with complete cervical dilation and effacement. Should she push now or delay pushing to allow for more descent?

More than 10,000 women give birth each day in the United States, yet few of our approaches to labor management are evidence based.² For example, there are no clear guidelines on whether immediate pushing or delayed pushing (waiting 1-2 hours) in the second stage of labor (the time from complete cervical dilation to delivery of the fetus) leads to better outcomes.

A recent Cochrane review, which included very low- to moderate-quality trials of nulliparous and multiparous women using epidural analgesia showed that delayed pushing resulted in more vaginal deliveries, longer duration of second stage of labor, and shorter duration of pushing.³ But many of the trials included in this Cochrane review were noted to have study design limitations and significant heterogeneity.

A recent retrospective study found that delayed pushing resulted in longer duration of pushing and increased risks for cesarean section, operative vaginal delivery, and postpartum hemorrhage in nulliparous patients with and without epidurals.⁴ The World Health Organization recommends delayed pushing in women with epidural analgesia if time and fetal monitoring resources are available.⁵

STUDY SUMMARY

Does the timing of second stage pushing efforts affect outcomes?

This multicenter randomized controlled trial (RCT) evaluated the effect on spontaneous vaginal delivery of delayed pushing vs immediate pushing in 2404 term nulliparous women using epidural analgesia.¹ Patients were ≥ 37 weeks’ gestation. Once patients achieved 10 cm of cervical dilation, they were randomized in a 1:1 ratio to either immediate pushing or to delayed (for 60 minutes) pushing (unless there was an irresistible urge to push or they were otherwise instructed by their provider).

Outcome and results. The primary outcome was spontaneous vaginal delivery without the use of any operative support. The mean time to pushing after complete cervical dilation was 19 minutes in the immediate pushing group and 60 minutes in the delayed group. There was no difference in the rate of spontaneous vaginal delivery between the immediate and delayed pushing groups (86% vs 87%, respectively; P = .67). The immediate pushing group had a shorter duration of second stage of labor (102 minutes vs 134 minutes; mean difference [MD] = –32 minutes; 95% confidence interval [CI], –37 to –27; P < .001) and a slightly longer duration of active pushing (84 minutes vs 75 minutes; MD = 9.2 minutes; 95% CI, 6-13; P < .001).

Delaying pushing once the cervix is completely dilated is not indicated, even for nulliparous women receiving epidural analgesia.

There was no significant difference in operative vaginal or cesarean deliveries. Postpartum hemorrhage was lower in the immediate pushing group (2.3% vs 4%; risk ratio [RR] = 0.6; 95% CI, 0.3-0.9; P = .03; number needed to treat [NNT] = 58), as was chorioamnionitis (6.7% vs 9.1%; RR = 0.7; 95% CI, 0.66-0.90; P = .005; NNT = 40). There was no significant difference in neonatal morbidity between groups. And in subgroup analysis, there was no significant difference in rates of vaginal delivery based on fetal position (occiput anterior, posterior, or transverse) or station (defined as high [< 2 cm] or low [≥ 2 cm]) between groups. Recruitment was stopped early at 75% because there was no difference in the primary outcome and there was concern regarding an increased risk of hemorrhage in the delayed pushing group.

Continue to: WHAT'S NEW

WHAT’S NEW

There’s no good reason to delay pushing

Delaying pushing once the cervix is completely dilated is not indicated, even for nulliparous women receiving epidural analgesia, as it does not decrease the rate of spontaneous vaginal delivery. It does, however, increase the length of second stage labor and the risk of postpartum hemorrhage and chorioamnionitis.

CAVEATS

Study was stopped early, and groups were unblinded

This study was stopped early, so it is not known if it was underpowered for some of the secondary outcomes. Also, it was not possible to blind the groups, so it is not clear if any bias in patient management or diagnosis resulted.

CHALLENGES TO IMPLEMENTATION

Will current practice and culture pose obstacles?

Although the overt challenges to enacting a policy of immediate pushing are minimal, the inertia of current practice and culture could affect the implementation of this strategy.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

U.S. Supreme Court justices appear divided over whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraception mandate.

jsmith/iStockphoto

During oral arguments on May 6, the court expressed differing perspectives about the administration’s authority to allow for more exemptions under the health law’s birth control mandate and whether the expansions were reasonable. Justices heard the consolidated cases – Little Sisters of the Poor v. Pennsylvania and Trump v. Pennsylvania – by teleconference because of the COVID-19 pandemic. They are expected to make a decision by the summer.

Associate justice Ruth Bader Ginsburg, who participated in the telephone conference call from a hospital where she was recovering from a gallbladder condition, said the exemptions ignored the intent of Congress to provide women with comprehensive coverage through the ACA.

“The glaring feature of what the government has done in expanding this exemption is to toss to the winds entirely Congress’s instruction that women need and shall have seamless, no-cost, comprehensive coverage,” she said during oral arguments. “This leaves the women to hunt for other government programs that might cover them, and for those who are not covered by Medicaid or one of the other government programs, they can get contraceptive coverage only from paying out of their own pocket, which is exactly what Congress didn’t want to happen.”

Associate Justice Samuel Alito Jr., meanwhile, indicated that a lower court opinion that had blocked the exemptions from going forward conflicts with the Supreme Court’s ruling in a related case, Burwell v. Hobby Lobby.

“Explain to me why the Third Circuit’s analysis of the question of substantial burden is not squarely inconsistent with our reasoning in Hobby Lobby,” Associate Justice Alito said during oral arguments. “Hobby Lobby held that, if a person sincerely believes that it is immoral to perform an act that has the effect of enabling another person to commit an immoral act, a federal court does not have the right to say that this person is wrong on the question of moral complicity. That’s precisely the situation here. Reading the Third Circuit’s discussion of the substantial burden question, I wondered whether they had read that part of the Hobby Lobby decision.”

The dispute surrounding the ACA’s birth control mandate and the extent of exemptions afforded has gone on for a decade and has led to numerous legal challenges. The ACA initially required all employers to cover birth control for employees with no copayments, but exempted group health plans of religious employers. Those religious employers were primarily churches and other houses of worship. After a number of complaints and lawsuits, the Obama administration created a workaround for nonprofit religious employers not included in that exemption to opt out of the mandate. However, critics argued the process itself was a violation of their religious freedom.

The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved however, and in May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.

In 2018, the Trump administration announced new rules aimed at broadening exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of “sincerely held religious beliefs.” A second rule allowed nonprofit organizations and small businesses that had nonreligious moral convictions against the mandate to opt out.

Thirteen states and the District of Columbia then sued the Trump administration over the rules, as well as Pennsylvania and New Jersey in a separate case. Little Sisters of the Poor, a religious nonprofit operating a home in Pittsburgh, intervened in the case as an aggrieved party. An appeal court temporarily barred the regulations from moving forward.

During oral arguments, Solicitor General for the Department of Justice Noel J. Francisco said the exemptions are lawful because they are authorized under a provision of the ACA as well as the Religious Freedom Restoration Act (RFRA).

“RFRA at the very least authorizes the religious exemption,” Mr. Francisco said during oral arguments.

Chief Deputy Attorney General for Pennsylvania Michael J. Fischer argued that the Trump administration’s moral and religious exemption rules rest on overly broad assertions of agency authority.

“First, the agencies twist a narrow delegation that allows the Health Resources and Services Administration to decide which preventive services insurers must cover under the Women’s Health Amendment into a grant of authority so broad it allows them to permit virtually any employer or college to opt out of providing contraceptive coverage entirely, including for reasons as amorphous as vaguely defined moral beliefs,” he said during oral arguments. “Second, the agencies claim that RFRA, a statute that limits government action, affirmatively authorizes them to permit employers to deny women their rights to contraceptive coverage even in the absence of a RFRA violation in the first place.”

agallegos@mdedge.com

U.S. Supreme Court justices appear divided over whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraception mandate.

jsmith/iStockphoto

During oral arguments on May 6, the court expressed differing perspectives about the administration’s authority to allow for more exemptions under the health law’s birth control mandate and whether the expansions were reasonable. Justices heard the consolidated cases – Little Sisters of the Poor v. Pennsylvania and Trump v. Pennsylvania – by teleconference because of the COVID-19 pandemic. They are expected to make a decision by the summer.

Associate justice Ruth Bader Ginsburg, who participated in the telephone conference call from a hospital where she was recovering from a gallbladder condition, said the exemptions ignored the intent of Congress to provide women with comprehensive coverage through the ACA.

“The glaring feature of what the government has done in expanding this exemption is to toss to the winds entirely Congress’s instruction that women need and shall have seamless, no-cost, comprehensive coverage,” she said during oral arguments. “This leaves the women to hunt for other government programs that might cover them, and for those who are not covered by Medicaid or one of the other government programs, they can get contraceptive coverage only from paying out of their own pocket, which is exactly what Congress didn’t want to happen.”

Associate Justice Samuel Alito Jr., meanwhile, indicated that a lower court opinion that had blocked the exemptions from going forward conflicts with the Supreme Court’s ruling in a related case, Burwell v. Hobby Lobby.

“Explain to me why the Third Circuit’s analysis of the question of substantial burden is not squarely inconsistent with our reasoning in Hobby Lobby,” Associate Justice Alito said during oral arguments. “Hobby Lobby held that, if a person sincerely believes that it is immoral to perform an act that has the effect of enabling another person to commit an immoral act, a federal court does not have the right to say that this person is wrong on the question of moral complicity. That’s precisely the situation here. Reading the Third Circuit’s discussion of the substantial burden question, I wondered whether they had read that part of the Hobby Lobby decision.”

The dispute surrounding the ACA’s birth control mandate and the extent of exemptions afforded has gone on for a decade and has led to numerous legal challenges. The ACA initially required all employers to cover birth control for employees with no copayments, but exempted group health plans of religious employers. Those religious employers were primarily churches and other houses of worship. After a number of complaints and lawsuits, the Obama administration created a workaround for nonprofit religious employers not included in that exemption to opt out of the mandate. However, critics argued the process itself was a violation of their religious freedom.

The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved however, and in May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.

In 2018, the Trump administration announced new rules aimed at broadening exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of “sincerely held religious beliefs.” A second rule allowed nonprofit organizations and small businesses that had nonreligious moral convictions against the mandate to opt out.

Thirteen states and the District of Columbia then sued the Trump administration over the rules, as well as Pennsylvania and New Jersey in a separate case. Little Sisters of the Poor, a religious nonprofit operating a home in Pittsburgh, intervened in the case as an aggrieved party. An appeal court temporarily barred the regulations from moving forward.

During oral arguments, Solicitor General for the Department of Justice Noel J. Francisco said the exemptions are lawful because they are authorized under a provision of the ACA as well as the Religious Freedom Restoration Act (RFRA).

“RFRA at the very least authorizes the religious exemption,” Mr. Francisco said during oral arguments.

Chief Deputy Attorney General for Pennsylvania Michael J. Fischer argued that the Trump administration’s moral and religious exemption rules rest on overly broad assertions of agency authority.

“First, the agencies twist a narrow delegation that allows the Health Resources and Services Administration to decide which preventive services insurers must cover under the Women’s Health Amendment into a grant of authority so broad it allows them to permit virtually any employer or college to opt out of providing contraceptive coverage entirely, including for reasons as amorphous as vaguely defined moral beliefs,” he said during oral arguments. “Second, the agencies claim that RFRA, a statute that limits government action, affirmatively authorizes them to permit employers to deny women their rights to contraceptive coverage even in the absence of a RFRA violation in the first place.”

agallegos@mdedge.com

U.S. Supreme Court justices appear divided over whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraception mandate.

jsmith/iStockphoto

During oral arguments on May 6, the court expressed differing perspectives about the administration’s authority to allow for more exemptions under the health law’s birth control mandate and whether the expansions were reasonable. Justices heard the consolidated cases – Little Sisters of the Poor v. Pennsylvania and Trump v. Pennsylvania – by teleconference because of the COVID-19 pandemic. They are expected to make a decision by the summer.

Associate justice Ruth Bader Ginsburg, who participated in the telephone conference call from a hospital where she was recovering from a gallbladder condition, said the exemptions ignored the intent of Congress to provide women with comprehensive coverage through the ACA.

“The glaring feature of what the government has done in expanding this exemption is to toss to the winds entirely Congress’s instruction that women need and shall have seamless, no-cost, comprehensive coverage,” she said during oral arguments. “This leaves the women to hunt for other government programs that might cover them, and for those who are not covered by Medicaid or one of the other government programs, they can get contraceptive coverage only from paying out of their own pocket, which is exactly what Congress didn’t want to happen.”

Associate Justice Samuel Alito Jr., meanwhile, indicated that a lower court opinion that had blocked the exemptions from going forward conflicts with the Supreme Court’s ruling in a related case, Burwell v. Hobby Lobby.

“Explain to me why the Third Circuit’s analysis of the question of substantial burden is not squarely inconsistent with our reasoning in Hobby Lobby,” Associate Justice Alito said during oral arguments. “Hobby Lobby held that, if a person sincerely believes that it is immoral to perform an act that has the effect of enabling another person to commit an immoral act, a federal court does not have the right to say that this person is wrong on the question of moral complicity. That’s precisely the situation here. Reading the Third Circuit’s discussion of the substantial burden question, I wondered whether they had read that part of the Hobby Lobby decision.”

The dispute surrounding the ACA’s birth control mandate and the extent of exemptions afforded has gone on for a decade and has led to numerous legal challenges. The ACA initially required all employers to cover birth control for employees with no copayments, but exempted group health plans of religious employers. Those religious employers were primarily churches and other houses of worship. After a number of complaints and lawsuits, the Obama administration created a workaround for nonprofit religious employers not included in that exemption to opt out of the mandate. However, critics argued the process itself was a violation of their religious freedom.

The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved however, and in May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.

In 2018, the Trump administration announced new rules aimed at broadening exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of “sincerely held religious beliefs.” A second rule allowed nonprofit organizations and small businesses that had nonreligious moral convictions against the mandate to opt out.

Thirteen states and the District of Columbia then sued the Trump administration over the rules, as well as Pennsylvania and New Jersey in a separate case. Little Sisters of the Poor, a religious nonprofit operating a home in Pittsburgh, intervened in the case as an aggrieved party. An appeal court temporarily barred the regulations from moving forward.

During oral arguments, Solicitor General for the Department of Justice Noel J. Francisco said the exemptions are lawful because they are authorized under a provision of the ACA as well as the Religious Freedom Restoration Act (RFRA).

“RFRA at the very least authorizes the religious exemption,” Mr. Francisco said during oral arguments.

Chief Deputy Attorney General for Pennsylvania Michael J. Fischer argued that the Trump administration’s moral and religious exemption rules rest on overly broad assertions of agency authority.

“First, the agencies twist a narrow delegation that allows the Health Resources and Services Administration to decide which preventive services insurers must cover under the Women’s Health Amendment into a grant of authority so broad it allows them to permit virtually any employer or college to opt out of providing contraceptive coverage entirely, including for reasons as amorphous as vaguely defined moral beliefs,” he said during oral arguments. “Second, the agencies claim that RFRA, a statute that limits government action, affirmatively authorizes them to permit employers to deny women their rights to contraceptive coverage even in the absence of a RFRA violation in the first place.”

agallegos@mdedge.com

THE CASE

A 28-year-old G1P1 initially presented to the family medicine clinic 4 weeks postpartum to discuss possibilities for contraception. She had received her prenatal care through a midwife and had had a successful home delivery. She was exclusively breastfeeding her infant daughter but wanted to ensure adequate spacing between her pregnancies.

During the discussion of possible options, the patient revealed that she had previously had an intrauterine device (IUD) placed and expressed interest in using this method again. A levonorgestrel-releasing IUD (Mirena) was placed at 6 weeks postpartum, after a negative pregnancy test was obtained.

The patient returned to the clinic about 6 months later with complaints of increased difficulty maintaining her milk supply.

THE DIAGNOSIS

The patient had taken a home pregnancy test, which was positive—a finding confirmed in clinic via a urine pregnancy test.

Gestational age. Since the patient had an IUD in place and had been exclusively breastfeeding, gestational age was difficult to determine. A quantitative human chorionic gonadotropin (hCG) test showed an hCG level of 12,469 U/L, consistent with a 4-to-8-week pregnancy. An ultrasound performed the next day showed a single intrauterine pregnancy at 21 weeks.

IUD location. There was also the question of the location of the IUD and whether it would interfere with the patient’s ability to maintain the pregnancy. On ultrasound, the IUD was noted within the cervix and myometrium. After discussion of the risks, the patient chose to leave it in place.

DISCUSSION

IUDs are among the most effective forms of contraception; levonorgestrel-releasing IUDs are more effective than copper IUDs.¹ The rates of failure in the first year of use are 0.8% and 0.2% for copper and levonorgestrel-releasing IUDs, respectively.¹

Continue to: The Lactational Amenorrhea Method

The Lactational Amenorrhea Method (LAM), which is defined as providing infant nutrition exclusively through breastmilk during the first 6 months postpartum, also provides protection against pregnancy. LAM has a failure rate of 0% to 1.5%.²

It is not surprising that this patient thought she was adequately protected against pregnancy. That said, no contraceptive method is foolproof (as this case demonstrates).

Risks to the pregnancy. When pregnancy does occur with an IUD in place, the patient should be informed of the possible risks to the pregnancy. These include complications such as spontaneous abortion, chorioamnionitis, and preterm delivery.³ Risk is further increased if the IUD is malpositioned (as this one was), meaning that any part of the IUD is located in the lower uterine segment, myometrium, or endocervical canal.^4,5

Removal of the IUD is generally recommended if the device and its strings can be located, although removal does not completely mitigate risk. In a study done in Egypt, 46 of 52 IUDs were removed successfully, with 2 spontaneous abortions as a result.⁶ Of note, the IUDs extracted in this study were Lippes loop and copper models, not levonorgestrel-releasing IUDs such as our patient had. There is a single case report⁷ of a patient who had a Mirena inserted very early in a pregnancy; the IUD had to be left in place due to the risk for miscarriage, but she was able to carry the infant to term and did not experience any adverse effects.

It is not surprising that this patient thought she was adequately protected against pregnancy.

Our patient

The patient delivered a male infant vaginally at term without issue. However, the IUD was not expelled during this process. Ultrasound showed that it was embedded in the posterior myometrium with a hypoechoic tract. The patient was referred to Gynecology, and the IUD was successfully removed.

Continue to: THE TAKEAWAY

Even the most reliable method of contraception can fail—so pregnancy should always be in the differential diagnosis for a sexually active woman. Location of IUD placement is important; it must be in the right place to be effective. The tenets of LAM must be followed precisely in order for breastfeeding to provide protection against pregnancy. Patients can successfully carry a pregnancy to term with an IUD, as this patient did, but it places them at higher risk for ectopic pregnancy, premature rupture of membranes, and infection.

ACKNOWLEDGEMENT
The author thanks Jenny Walters, lactation consultant, for her assistance in the preparation of the manuscript.

CORRESPONDENCE
Hannah Maxfield, MD, 3901 Rainbow Boulevard, MS 4010, Kansas City, KS 66160; hmaxfield@kumc.edu

THE CASE

A 28-year-old G1P1 initially presented to the family medicine clinic 4 weeks postpartum to discuss possibilities for contraception. She had received her prenatal care through a midwife and had had a successful home delivery. She was exclusively breastfeeding her infant daughter but wanted to ensure adequate spacing between her pregnancies.

During the discussion of possible options, the patient revealed that she had previously had an intrauterine device (IUD) placed and expressed interest in using this method again. A levonorgestrel-releasing IUD (Mirena) was placed at 6 weeks postpartum, after a negative pregnancy test was obtained.

The patient returned to the clinic about 6 months later with complaints of increased difficulty maintaining her milk supply.

THE DIAGNOSIS

The patient had taken a home pregnancy test, which was positive—a finding confirmed in clinic via a urine pregnancy test.

Gestational age. Since the patient had an IUD in place and had been exclusively breastfeeding, gestational age was difficult to determine. A quantitative human chorionic gonadotropin (hCG) test showed an hCG level of 12,469 U/L, consistent with a 4-to-8-week pregnancy. An ultrasound performed the next day showed a single intrauterine pregnancy at 21 weeks.

IUD location. There was also the question of the location of the IUD and whether it would interfere with the patient’s ability to maintain the pregnancy. On ultrasound, the IUD was noted within the cervix and myometrium. After discussion of the risks, the patient chose to leave it in place.

DISCUSSION

IUDs are among the most effective forms of contraception; levonorgestrel-releasing IUDs are more effective than copper IUDs.¹ The rates of failure in the first year of use are 0.8% and 0.2% for copper and levonorgestrel-releasing IUDs, respectively.¹

Continue to: The Lactational Amenorrhea Method

The Lactational Amenorrhea Method (LAM), which is defined as providing infant nutrition exclusively through breastmilk during the first 6 months postpartum, also provides protection against pregnancy. LAM has a failure rate of 0% to 1.5%.²

It is not surprising that this patient thought she was adequately protected against pregnancy. That said, no contraceptive method is foolproof (as this case demonstrates).

Risks to the pregnancy. When pregnancy does occur with an IUD in place, the patient should be informed of the possible risks to the pregnancy. These include complications such as spontaneous abortion, chorioamnionitis, and preterm delivery.³ Risk is further increased if the IUD is malpositioned (as this one was), meaning that any part of the IUD is located in the lower uterine segment, myometrium, or endocervical canal.^4,5

Removal of the IUD is generally recommended if the device and its strings can be located, although removal does not completely mitigate risk. In a study done in Egypt, 46 of 52 IUDs were removed successfully, with 2 spontaneous abortions as a result.⁶ Of note, the IUDs extracted in this study were Lippes loop and copper models, not levonorgestrel-releasing IUDs such as our patient had. There is a single case report⁷ of a patient who had a Mirena inserted very early in a pregnancy; the IUD had to be left in place due to the risk for miscarriage, but she was able to carry the infant to term and did not experience any adverse effects.

It is not surprising that this patient thought she was adequately protected against pregnancy.

Our patient

The patient delivered a male infant vaginally at term without issue. However, the IUD was not expelled during this process. Ultrasound showed that it was embedded in the posterior myometrium with a hypoechoic tract. The patient was referred to Gynecology, and the IUD was successfully removed.

Continue to: THE TAKEAWAY

Even the most reliable method of contraception can fail—so pregnancy should always be in the differential diagnosis for a sexually active woman. Location of IUD placement is important; it must be in the right place to be effective. The tenets of LAM must be followed precisely in order for breastfeeding to provide protection against pregnancy. Patients can successfully carry a pregnancy to term with an IUD, as this patient did, but it places them at higher risk for ectopic pregnancy, premature rupture of membranes, and infection.

ACKNOWLEDGEMENT
The author thanks Jenny Walters, lactation consultant, for her assistance in the preparation of the manuscript.

CORRESPONDENCE
Hannah Maxfield, MD, 3901 Rainbow Boulevard, MS 4010, Kansas City, KS 66160; hmaxfield@kumc.edu

THE CASE

A 28-year-old G1P1 initially presented to the family medicine clinic 4 weeks postpartum to discuss possibilities for contraception. She had received her prenatal care through a midwife and had had a successful home delivery. She was exclusively breastfeeding her infant daughter but wanted to ensure adequate spacing between her pregnancies.

During the discussion of possible options, the patient revealed that she had previously had an intrauterine device (IUD) placed and expressed interest in using this method again. A levonorgestrel-releasing IUD (Mirena) was placed at 6 weeks postpartum, after a negative pregnancy test was obtained.

The patient returned to the clinic about 6 months later with complaints of increased difficulty maintaining her milk supply.

THE DIAGNOSIS

The patient had taken a home pregnancy test, which was positive—a finding confirmed in clinic via a urine pregnancy test.

Gestational age. Since the patient had an IUD in place and had been exclusively breastfeeding, gestational age was difficult to determine. A quantitative human chorionic gonadotropin (hCG) test showed an hCG level of 12,469 U/L, consistent with a 4-to-8-week pregnancy. An ultrasound performed the next day showed a single intrauterine pregnancy at 21 weeks.

IUD location. There was also the question of the location of the IUD and whether it would interfere with the patient’s ability to maintain the pregnancy. On ultrasound, the IUD was noted within the cervix and myometrium. After discussion of the risks, the patient chose to leave it in place.

DISCUSSION

IUDs are among the most effective forms of contraception; levonorgestrel-releasing IUDs are more effective than copper IUDs.¹ The rates of failure in the first year of use are 0.8% and 0.2% for copper and levonorgestrel-releasing IUDs, respectively.¹

Continue to: The Lactational Amenorrhea Method

The Lactational Amenorrhea Method (LAM), which is defined as providing infant nutrition exclusively through breastmilk during the first 6 months postpartum, also provides protection against pregnancy. LAM has a failure rate of 0% to 1.5%.²

It is not surprising that this patient thought she was adequately protected against pregnancy. That said, no contraceptive method is foolproof (as this case demonstrates).

Risks to the pregnancy. When pregnancy does occur with an IUD in place, the patient should be informed of the possible risks to the pregnancy. These include complications such as spontaneous abortion, chorioamnionitis, and preterm delivery.³ Risk is further increased if the IUD is malpositioned (as this one was), meaning that any part of the IUD is located in the lower uterine segment, myometrium, or endocervical canal.^4,5

Removal of the IUD is generally recommended if the device and its strings can be located, although removal does not completely mitigate risk. In a study done in Egypt, 46 of 52 IUDs were removed successfully, with 2 spontaneous abortions as a result.⁶ Of note, the IUDs extracted in this study were Lippes loop and copper models, not levonorgestrel-releasing IUDs such as our patient had. There is a single case report⁷ of a patient who had a Mirena inserted very early in a pregnancy; the IUD had to be left in place due to the risk for miscarriage, but she was able to carry the infant to term and did not experience any adverse effects.

It is not surprising that this patient thought she was adequately protected against pregnancy.

Our patient

The patient delivered a male infant vaginally at term without issue. However, the IUD was not expelled during this process. Ultrasound showed that it was embedded in the posterior myometrium with a hypoechoic tract. The patient was referred to Gynecology, and the IUD was successfully removed.

Continue to: THE TAKEAWAY

Even the most reliable method of contraception can fail—so pregnancy should always be in the differential diagnosis for a sexually active woman. Location of IUD placement is important; it must be in the right place to be effective. The tenets of LAM must be followed precisely in order for breastfeeding to provide protection against pregnancy. Patients can successfully carry a pregnancy to term with an IUD, as this patient did, but it places them at higher risk for ectopic pregnancy, premature rupture of membranes, and infection.

ACKNOWLEDGEMENT
The author thanks Jenny Walters, lactation consultant, for her assistance in the preparation of the manuscript.

CORRESPONDENCE
Hannah Maxfield, MD, 3901 Rainbow Boulevard, MS 4010, Kansas City, KS 66160; hmaxfield@kumc.edu

In 2019, the US Preventive Services Task Force published 19 recommendation statements on 11 topics. Two of the topics are new; 9 are topics the Task Force had previously reviewed and has updated (TABLE 1). Three of these topics have been covered in Practice Alert podcasts (mdedge.com/familymedicine) and will not be discussed here: risk assessment, genetic counseling, and genetic testing for breast cancer susceptibility gene mutations (October 2019); medications to reduce the risk of breast cancer (December 2019); and preexposure prophylaxis to prevent HIV infections (January 2020).

Of the 19 recommendation statements made in 2019 (TABLE 2), 5 were rated “A” and 5 were “B,” meaning the evidence shows that benefits outweigh harms and these interventions should be offered in primary care practice. There were 5 “D” recommendations for interventions that should not be offered because they are either ineffective or harms exceed benefits. There were 3 “I” statements on interventions having insufficient evidence on benefits or harms to warrant a recommendation. Only 1 recommendation was rated “C” (selectively offer based on individual factors); this assessment is the hardest one to interpret and implement. Keep in mind that all “A” and “B” recommendations must be covered by commercial health plans with no out-of-pocket cost to the patient (ie, no co-pay or deductible).

New recommendation on preventing perinatal depression

One of 2 new topics reviewed in 2019 was the prevention of perinatal depression. (As noted, the other on preexposure prophylaxis to prevent HIV infection has already been covered in a Practice Alert podcast.) The Task Force found that the prevalence of depression is estimated at 8.9% among pregnant women and 37% at any point in the first year postpartum.¹

Depression during pregnancy and the postpartum period is associated with adverse effects on the mother and infant, including higher rates of suicide and suicidal ideation and thoughts of harming the infant.¹ Women with perinatal depression are also more likely to exhibit significantly lower levels of positive maternal behaviors, such as praising and playing with their child,² and higher rates of negative maternal behaviors.² Perinatal depression is also associated with increased rates of preterm birth and low birth weight.³

Mothers with postpartum depression have higher rates of early termination of breast feeding and lower adherence for recommended child preventive services including vaccination.¹ Children of mothers with perinatal depression develop more behavior problems, have lower cognitive functioning, and have an increased risk of psychiatric disorders than do children of mothers without this condition.^4,5

A number of risk factors are associated with perinatal depression, but no screening tool was found to have enough predictive value to be recommended. In deciding who should receive an offer or referral for counseling, the Task Force recommends as a practical approach providing “counseling interventions to women with 1 or more of the following: a history of depression, current depressive symptoms (that do not reach a diagnostic threshold), certain socioeconomic risk factors such as low income or adolescent or single parenthood, recent intimate partner violence, or mental health-related factors such as elevated anxiety symptoms or a history of significant negative life events.”¹

There is no conclusive evidence to guide timing of counseling interventions, but most studies reviewed started them in the second trimester. These studies included cognitive behavioral therapy and interpersonal therapy and involved counseling sessions that ranged from 4 to 20 sessions and lasted for 4 to 70 weeks. They involved group and individual sessions, mostly in-person visits, and were provided by a variety of health professionals.⁶

Continue to: The studies reviewed showed...

The studies reviewed showed that counseling interventions reduced the likelihood of developing depression symptoms by 39%, with a number needed to treat of 13.5.⁶ Studies that looked at pregnancy and maternal and infant clinical outcomes were mixed but usually found little to no difference with counseling.⁶ Even so, the Task Force felt that a reduction in depression itself was enough to warrant a “B” recommendation.

Screening for abdominal aortic aneurisms

Ultrasound is underused in screening for abdominal aortic aneurisms (AAA) and preventing death from their rupture. (See “Whom should you screen for abdominal aortic aneurysm?”) The prevalence of AAA is the United States is unknown; in other western countries it varies from 1.2% to 3.3% in men and is declining due to decreased rates of smoking, the primary risk factor.

The risk of AAA rupture is related to the size of the aneurism, and surgical repair (either endovascular or open repair) is usually reserved for lesions > 5.5 cm in diameter or for smaller ones that are rapidly increasing in size. The standard of care for most aneurysms < 5.5 cm is to periodically monitor growth ­using ultrasound.

The 2019 recommendations on AAA screening are essentially the same as those made in 2004; evaluation of new evidence supported the previous recommendations. The Task Force recommends one-time screening for men ages 65 to 75 years who have ever smoked (B recommendation). Selective screening is recommended for men in this age group who have never smoked, based mainly on personal factors such as a family history of AAA, the presence of other arterial aneurisms, and the number of risk factors for cardiovascular disease (C recommendation).

The Task Force recommends against screening women ages 65 to 75 years with no history of smoking or family history of AAA, while the evidence was felt to be insufficient to make a recommendation for women in this age range who have either risk factor. This is problematic for family physicians since women with these risk factors are at increased risk of AAA compared with women without risk factors.⁸ And aneurisms in women appear to rupture more frequently at smaller sizes, although at a later age than in men.⁸ Operative mortality is also higher in women than in men⁸ and there is no direct evidence that screening improves outcomes for women.

Continue to: Screening for asymptomatic bacteriuria

The Task Force re-examined and reconfirmed its previous recommendations on screening for asymptomatic bacteriuria in adults. It recommends in favor of it for pregnant women, using a urine culture to screen, and against it for all other adults. There is good evidence that treating screen-detected asymptomatic bacteriuria in pregnant women reduces the incidence of pyelonephritis in pregnancy.

The Task Force made this a “B” recommendation based on a lower prevalence of pyelonephritis found in more recent studies, making the overall magnitude of benefits moderate. There is also good evidence that treating asymptomatic bacteriuria in nonpregnant adults offers no benefits.⁹ The Task Force has re-examined this topic 5 times since 1996 with essentially the same results.

Screening for elevated lead levels in children and pregnant women

In 2019 the Task Force changed its 2006 recommendation on screening for elevated lead levels. The earlier recommendation advised against screening both children ages 1 to 5 years and pregnant women at average risk for elevated blood lead levels. In 2006 the Task Force also felt that evidence was insufficient to make a recommendation regarding children ages 1 to 5 years at elevated risk.

The Task Force now believes the evidence is insufficient to make a recommendation for all children ages 1 to 5 years and for pregnant women, thus moving from a “D” to an “I” recommendation for children and pregnant women with average risk. Even though there is little evidence to support screening for elevated lead levels in children ages 1 to 5 years and in pregnant women, the Task Force apparently did not feel comfortable recommending against testing, given that the cutoff for elevated blood lead levels has been lowered from 10 to 5 mcg/dL and that other sources of lead may now be more prevalent than in 2006.¹⁰

Perinatal counseling of women with known risks of depression reduces the likelihood of depressive symptoms by 39%.

Remember that the Medicaid Early and Periodic Screening, Diagnostic, and Treatment program requires that all children receive a blood lead test twice, at ages 12 and 24 months, and that previously unscreened children ages 36 to 72 months must be tested once.

Continue to: Additional updates with no recommendation changes

Four other topics were re-examined by the Task Force in 2019, resulting in no significant changes to recommendations (TABLE 2):

• Screen for hepatitis B infection in pregnant women at the first prenatal visit (A recommendation; updated from 2009).
• Screen for HIV infection in adolescents and adults ages 15 to 65 years, and in those younger and older who are at high risk, and during pregnancy (A recommendation; updated from 2013).
• Provide topical medication for all newborns to prevent gonococcal ophthalmia neonatorum (A recommendation; first recommendation in 1996, updated in 2005 and 2011).
• Avoid screening for pancreatic cancer in asymptomatic adults (D recommendation; updated from 2004).

Affirmation of USPSTF’s value

In only 1 out of 9 reassessments of past topics did the Task Force modify its previous recommendations in any significant way. This demonstrates that recommendations will usually stand the test of time if they are made using robust, evidence-based methods (that consider both benefits and harms) and they are not made when evidence is insufficient. That only 2 new topics could be addressed in 2019 may reflect a need for more resources for the Task Force.

In 2019, the US Preventive Services Task Force published 19 recommendation statements on 11 topics. Two of the topics are new; 9 are topics the Task Force had previously reviewed and has updated (TABLE 1). Three of these topics have been covered in Practice Alert podcasts (mdedge.com/familymedicine) and will not be discussed here: risk assessment, genetic counseling, and genetic testing for breast cancer susceptibility gene mutations (October 2019); medications to reduce the risk of breast cancer (December 2019); and preexposure prophylaxis to prevent HIV infections (January 2020).

Of the 19 recommendation statements made in 2019 (TABLE 2), 5 were rated “A” and 5 were “B,” meaning the evidence shows that benefits outweigh harms and these interventions should be offered in primary care practice. There were 5 “D” recommendations for interventions that should not be offered because they are either ineffective or harms exceed benefits. There were 3 “I” statements on interventions having insufficient evidence on benefits or harms to warrant a recommendation. Only 1 recommendation was rated “C” (selectively offer based on individual factors); this assessment is the hardest one to interpret and implement. Keep in mind that all “A” and “B” recommendations must be covered by commercial health plans with no out-of-pocket cost to the patient (ie, no co-pay or deductible).

New recommendation on preventing perinatal depression

One of 2 new topics reviewed in 2019 was the prevention of perinatal depression. (As noted, the other on preexposure prophylaxis to prevent HIV infection has already been covered in a Practice Alert podcast.) The Task Force found that the prevalence of depression is estimated at 8.9% among pregnant women and 37% at any point in the first year postpartum.¹

Depression during pregnancy and the postpartum period is associated with adverse effects on the mother and infant, including higher rates of suicide and suicidal ideation and thoughts of harming the infant.¹ Women with perinatal depression are also more likely to exhibit significantly lower levels of positive maternal behaviors, such as praising and playing with their child,² and higher rates of negative maternal behaviors.² Perinatal depression is also associated with increased rates of preterm birth and low birth weight.³

Mothers with postpartum depression have higher rates of early termination of breast feeding and lower adherence for recommended child preventive services including vaccination.¹ Children of mothers with perinatal depression develop more behavior problems, have lower cognitive functioning, and have an increased risk of psychiatric disorders than do children of mothers without this condition.^4,5

A number of risk factors are associated with perinatal depression, but no screening tool was found to have enough predictive value to be recommended. In deciding who should receive an offer or referral for counseling, the Task Force recommends as a practical approach providing “counseling interventions to women with 1 or more of the following: a history of depression, current depressive symptoms (that do not reach a diagnostic threshold), certain socioeconomic risk factors such as low income or adolescent or single parenthood, recent intimate partner violence, or mental health-related factors such as elevated anxiety symptoms or a history of significant negative life events.”¹

There is no conclusive evidence to guide timing of counseling interventions, but most studies reviewed started them in the second trimester. These studies included cognitive behavioral therapy and interpersonal therapy and involved counseling sessions that ranged from 4 to 20 sessions and lasted for 4 to 70 weeks. They involved group and individual sessions, mostly in-person visits, and were provided by a variety of health professionals.⁶

Continue to: The studies reviewed showed...

The studies reviewed showed that counseling interventions reduced the likelihood of developing depression symptoms by 39%, with a number needed to treat of 13.5.⁶ Studies that looked at pregnancy and maternal and infant clinical outcomes were mixed but usually found little to no difference with counseling.⁶ Even so, the Task Force felt that a reduction in depression itself was enough to warrant a “B” recommendation.

Screening for abdominal aortic aneurisms

Ultrasound is underused in screening for abdominal aortic aneurisms (AAA) and preventing death from their rupture. (See “Whom should you screen for abdominal aortic aneurysm?”) The prevalence of AAA is the United States is unknown; in other western countries it varies from 1.2% to 3.3% in men and is declining due to decreased rates of smoking, the primary risk factor.

The risk of AAA rupture is related to the size of the aneurism, and surgical repair (either endovascular or open repair) is usually reserved for lesions > 5.5 cm in diameter or for smaller ones that are rapidly increasing in size. The standard of care for most aneurysms < 5.5 cm is to periodically monitor growth ­using ultrasound.

The 2019 recommendations on AAA screening are essentially the same as those made in 2004; evaluation of new evidence supported the previous recommendations. The Task Force recommends one-time screening for men ages 65 to 75 years who have ever smoked (B recommendation). Selective screening is recommended for men in this age group who have never smoked, based mainly on personal factors such as a family history of AAA, the presence of other arterial aneurisms, and the number of risk factors for cardiovascular disease (C recommendation).

The Task Force recommends against screening women ages 65 to 75 years with no history of smoking or family history of AAA, while the evidence was felt to be insufficient to make a recommendation for women in this age range who have either risk factor. This is problematic for family physicians since women with these risk factors are at increased risk of AAA compared with women without risk factors.⁸ And aneurisms in women appear to rupture more frequently at smaller sizes, although at a later age than in men.⁸ Operative mortality is also higher in women than in men⁸ and there is no direct evidence that screening improves outcomes for women.

Continue to: Screening for asymptomatic bacteriuria

The Task Force re-examined and reconfirmed its previous recommendations on screening for asymptomatic bacteriuria in adults. It recommends in favor of it for pregnant women, using a urine culture to screen, and against it for all other adults. There is good evidence that treating screen-detected asymptomatic bacteriuria in pregnant women reduces the incidence of pyelonephritis in pregnancy.

The Task Force made this a “B” recommendation based on a lower prevalence of pyelonephritis found in more recent studies, making the overall magnitude of benefits moderate. There is also good evidence that treating asymptomatic bacteriuria in nonpregnant adults offers no benefits.⁹ The Task Force has re-examined this topic 5 times since 1996 with essentially the same results.

Screening for elevated lead levels in children and pregnant women

In 2019 the Task Force changed its 2006 recommendation on screening for elevated lead levels. The earlier recommendation advised against screening both children ages 1 to 5 years and pregnant women at average risk for elevated blood lead levels. In 2006 the Task Force also felt that evidence was insufficient to make a recommendation regarding children ages 1 to 5 years at elevated risk.

The Task Force now believes the evidence is insufficient to make a recommendation for all children ages 1 to 5 years and for pregnant women, thus moving from a “D” to an “I” recommendation for children and pregnant women with average risk. Even though there is little evidence to support screening for elevated lead levels in children ages 1 to 5 years and in pregnant women, the Task Force apparently did not feel comfortable recommending against testing, given that the cutoff for elevated blood lead levels has been lowered from 10 to 5 mcg/dL and that other sources of lead may now be more prevalent than in 2006.¹⁰

Perinatal counseling of women with known risks of depression reduces the likelihood of depressive symptoms by 39%.

Remember that the Medicaid Early and Periodic Screening, Diagnostic, and Treatment program requires that all children receive a blood lead test twice, at ages 12 and 24 months, and that previously unscreened children ages 36 to 72 months must be tested once.

Continue to: Additional updates with no recommendation changes

Four other topics were re-examined by the Task Force in 2019, resulting in no significant changes to recommendations (TABLE 2):

• Screen for hepatitis B infection in pregnant women at the first prenatal visit (A recommendation; updated from 2009).
• Screen for HIV infection in adolescents and adults ages 15 to 65 years, and in those younger and older who are at high risk, and during pregnancy (A recommendation; updated from 2013).
• Provide topical medication for all newborns to prevent gonococcal ophthalmia neonatorum (A recommendation; first recommendation in 1996, updated in 2005 and 2011).
• Avoid screening for pancreatic cancer in asymptomatic adults (D recommendation; updated from 2004).

Affirmation of USPSTF’s value

In only 1 out of 9 reassessments of past topics did the Task Force modify its previous recommendations in any significant way. This demonstrates that recommendations will usually stand the test of time if they are made using robust, evidence-based methods (that consider both benefits and harms) and they are not made when evidence is insufficient. That only 2 new topics could be addressed in 2019 may reflect a need for more resources for the Task Force.

In 2019, the US Preventive Services Task Force published 19 recommendation statements on 11 topics. Two of the topics are new; 9 are topics the Task Force had previously reviewed and has updated (TABLE 1). Three of these topics have been covered in Practice Alert podcasts (mdedge.com/familymedicine) and will not be discussed here: risk assessment, genetic counseling, and genetic testing for breast cancer susceptibility gene mutations (October 2019); medications to reduce the risk of breast cancer (December 2019); and preexposure prophylaxis to prevent HIV infections (January 2020).

Of the 19 recommendation statements made in 2019 (TABLE 2), 5 were rated “A” and 5 were “B,” meaning the evidence shows that benefits outweigh harms and these interventions should be offered in primary care practice. There were 5 “D” recommendations for interventions that should not be offered because they are either ineffective or harms exceed benefits. There were 3 “I” statements on interventions having insufficient evidence on benefits or harms to warrant a recommendation. Only 1 recommendation was rated “C” (selectively offer based on individual factors); this assessment is the hardest one to interpret and implement. Keep in mind that all “A” and “B” recommendations must be covered by commercial health plans with no out-of-pocket cost to the patient (ie, no co-pay or deductible).

New recommendation on preventing perinatal depression

One of 2 new topics reviewed in 2019 was the prevention of perinatal depression. (As noted, the other on preexposure prophylaxis to prevent HIV infection has already been covered in a Practice Alert podcast.) The Task Force found that the prevalence of depression is estimated at 8.9% among pregnant women and 37% at any point in the first year postpartum.¹

Depression during pregnancy and the postpartum period is associated with adverse effects on the mother and infant, including higher rates of suicide and suicidal ideation and thoughts of harming the infant.¹ Women with perinatal depression are also more likely to exhibit significantly lower levels of positive maternal behaviors, such as praising and playing with their child,² and higher rates of negative maternal behaviors.² Perinatal depression is also associated with increased rates of preterm birth and low birth weight.³

Mothers with postpartum depression have higher rates of early termination of breast feeding and lower adherence for recommended child preventive services including vaccination.¹ Children of mothers with perinatal depression develop more behavior problems, have lower cognitive functioning, and have an increased risk of psychiatric disorders than do children of mothers without this condition.^4,5

A number of risk factors are associated with perinatal depression, but no screening tool was found to have enough predictive value to be recommended. In deciding who should receive an offer or referral for counseling, the Task Force recommends as a practical approach providing “counseling interventions to women with 1 or more of the following: a history of depression, current depressive symptoms (that do not reach a diagnostic threshold), certain socioeconomic risk factors such as low income or adolescent or single parenthood, recent intimate partner violence, or mental health-related factors such as elevated anxiety symptoms or a history of significant negative life events.”¹

There is no conclusive evidence to guide timing of counseling interventions, but most studies reviewed started them in the second trimester. These studies included cognitive behavioral therapy and interpersonal therapy and involved counseling sessions that ranged from 4 to 20 sessions and lasted for 4 to 70 weeks. They involved group and individual sessions, mostly in-person visits, and were provided by a variety of health professionals.⁶

Continue to: The studies reviewed showed...

The studies reviewed showed that counseling interventions reduced the likelihood of developing depression symptoms by 39%, with a number needed to treat of 13.5.⁶ Studies that looked at pregnancy and maternal and infant clinical outcomes were mixed but usually found little to no difference with counseling.⁶ Even so, the Task Force felt that a reduction in depression itself was enough to warrant a “B” recommendation.

Screening for abdominal aortic aneurisms

Ultrasound is underused in screening for abdominal aortic aneurisms (AAA) and preventing death from their rupture. (See “Whom should you screen for abdominal aortic aneurysm?”) The prevalence of AAA is the United States is unknown; in other western countries it varies from 1.2% to 3.3% in men and is declining due to decreased rates of smoking, the primary risk factor.

The risk of AAA rupture is related to the size of the aneurism, and surgical repair (either endovascular or open repair) is usually reserved for lesions > 5.5 cm in diameter or for smaller ones that are rapidly increasing in size. The standard of care for most aneurysms < 5.5 cm is to periodically monitor growth ­using ultrasound.

The 2019 recommendations on AAA screening are essentially the same as those made in 2004; evaluation of new evidence supported the previous recommendations. The Task Force recommends one-time screening for men ages 65 to 75 years who have ever smoked (B recommendation). Selective screening is recommended for men in this age group who have never smoked, based mainly on personal factors such as a family history of AAA, the presence of other arterial aneurisms, and the number of risk factors for cardiovascular disease (C recommendation).

The Task Force recommends against screening women ages 65 to 75 years with no history of smoking or family history of AAA, while the evidence was felt to be insufficient to make a recommendation for women in this age range who have either risk factor. This is problematic for family physicians since women with these risk factors are at increased risk of AAA compared with women without risk factors.⁸ And aneurisms in women appear to rupture more frequently at smaller sizes, although at a later age than in men.⁸ Operative mortality is also higher in women than in men⁸ and there is no direct evidence that screening improves outcomes for women.

Continue to: Screening for asymptomatic bacteriuria

The Task Force re-examined and reconfirmed its previous recommendations on screening for asymptomatic bacteriuria in adults. It recommends in favor of it for pregnant women, using a urine culture to screen, and against it for all other adults. There is good evidence that treating screen-detected asymptomatic bacteriuria in pregnant women reduces the incidence of pyelonephritis in pregnancy.

The Task Force made this a “B” recommendation based on a lower prevalence of pyelonephritis found in more recent studies, making the overall magnitude of benefits moderate. There is also good evidence that treating asymptomatic bacteriuria in nonpregnant adults offers no benefits.⁹ The Task Force has re-examined this topic 5 times since 1996 with essentially the same results.

Screening for elevated lead levels in children and pregnant women

In 2019 the Task Force changed its 2006 recommendation on screening for elevated lead levels. The earlier recommendation advised against screening both children ages 1 to 5 years and pregnant women at average risk for elevated blood lead levels. In 2006 the Task Force also felt that evidence was insufficient to make a recommendation regarding children ages 1 to 5 years at elevated risk.

The Task Force now believes the evidence is insufficient to make a recommendation for all children ages 1 to 5 years and for pregnant women, thus moving from a “D” to an “I” recommendation for children and pregnant women with average risk. Even though there is little evidence to support screening for elevated lead levels in children ages 1 to 5 years and in pregnant women, the Task Force apparently did not feel comfortable recommending against testing, given that the cutoff for elevated blood lead levels has been lowered from 10 to 5 mcg/dL and that other sources of lead may now be more prevalent than in 2006.¹⁰

Perinatal counseling of women with known risks of depression reduces the likelihood of depressive symptoms by 39%.

Remember that the Medicaid Early and Periodic Screening, Diagnostic, and Treatment program requires that all children receive a blood lead test twice, at ages 12 and 24 months, and that previously unscreened children ages 36 to 72 months must be tested once.

Continue to: Additional updates with no recommendation changes

Four other topics were re-examined by the Task Force in 2019, resulting in no significant changes to recommendations (TABLE 2):

• Screen for hepatitis B infection in pregnant women at the first prenatal visit (A recommendation; updated from 2009).
• Screen for HIV infection in adolescents and adults ages 15 to 65 years, and in those younger and older who are at high risk, and during pregnancy (A recommendation; updated from 2013).
• Provide topical medication for all newborns to prevent gonococcal ophthalmia neonatorum (A recommendation; first recommendation in 1996, updated in 2005 and 2011).
• Avoid screening for pancreatic cancer in asymptomatic adults (D recommendation; updated from 2004).

Affirmation of USPSTF’s value

In only 1 out of 9 reassessments of past topics did the Task Force modify its previous recommendations in any significant way. This demonstrates that recommendations will usually stand the test of time if they are made using robust, evidence-based methods (that consider both benefits and harms) and they are not made when evidence is insufficient. That only 2 new topics could be addressed in 2019 may reflect a need for more resources for the Task Force.

Women with cardiovascular conditions who are planning pregnancy should be assessed and managed by a multidisciplinary team to ensure the best outcomes, according to a statement from the American Heart Association.

©American Heart Association

Cardiovascular disease (CVD) remains the leading cause of pregnancy-related mortality in the United States, and accounted for approximately 17 deaths per 100,000 live births in 2015, wrote Laxmi S. Mehta, MD, of The Ohio State University, Columbus, and colleagues.

Ideally, a woman with CVD at the time of pregnancy should be managed by a multidisciplinary cardio-obstetrics team that can assess cardiovascular risk, obstetric risk, and fetal risk throughout pregnancy, delivery, and up to a year post partum. The team should develop a shared strategy to promote best outcomes, according to the statement. The cardio-obstetrics team may include obstetricians, cardiologists, anesthesiologists, maternal-fetal medicine specialists, geneticists, neurologists, nurses, and pharmacists, according to the statement.

Women with preexisting CVD should receive counseling about maternal and fetal risks before conception, if possible, to involve the women in shared decision-making and to develop strategies for each stage of pregnancy and delivery, Dr. Mehta and associates said. Such counseling should include a review of all medications and assessment of risk factors.

However, some women present already in the early stages of pregnancy even with severe conditions such as pulmonary arterial hypertension, severe ventricular dysfunction, severe left-sided heart obstruction, and significant aortic dilatation with underlying connective tissue disease. Women with these conditions often are counseled to avoid pregnancy, but if they already are pregnant, a high-risk cardio-obstetrics team will need to work together to discover the best strategies going forward to mitigate risk, Dr. Mehta and associates said.

Common CVD conditions that affect pregnancy include hypertensive disorders, notably preeclampsia, defined as systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg in women after 20 weeks of gestation whose blood pressure was normal prior to pregnancy. A management strategy to reduce the risk of pregnancy-related complications from hypertension includes healthy lifestyle behaviors such as exercise, nutrition, and smoking cessation, according to the statement. However, patients with severe hypertension may require intravenous labetalol or hydralazine. The statement gives more information about handling preeclampsia with pulmonary edema, and prevention of eclampsia and treatment of seizures.

It is important to recognize that severe hypertension or superimposed preeclampsia may occur for the first time post partum. Early ambulatory visits in the first 1-2 weeks are sensible. Medications may be needed to keep a systolic blood pressure not higher than 150 mm Hg and a diastolic blood pressure not higher than 100 mm Hg, Dr. Mehta and associates said.

According to the statement, severe hypertriglyceridemia and familial hypercholesterolemia are the two most common conditions in which lipids should be addressed during pregnancy, with consideration of the fetal risks associated with certain medications.

“Statins are contraindicated during pregnancy, and all women who are on any lipid-lowering agents should review with their physician the safety of treatment during pregnancy and whether to discontinue treatment before pregnancy,” according to the statement. A heart-healthy lifestyle can help improve lipid profiles in all pregnant patients, Dr. Mehta and associates said. Patients with extremely high triglycerides above 500 mg/dL are at risk of pancreatitis and “may benefit from pharmacological agents (omega-3 fatty acids with or without fenofibrate or gemfibrozil) during the second trimester,” they noted. Pregnant women with familial hypercholesterolemia might take bile acid sequestrants, or as a last resort, low-density lipoprotein apheresis.

Other conditions calling for a multidisciplinary cardio-obstetric approach include preexisting coronary artery disease, cardiomyopathies, arrhythmias, valvular heart disease, cerebrovascular disease, and deep venous thrombosis, according to the statement, which provides information about the risks, diagnosis, and management.

When it is time for delivery, spontaneous labor and vaginal birth are preferable for most women with heart disease, as cesarean delivery is associated with increased risk of infection, thrombotic complications, and blood loss, according to the statement.

Women with CVD and associated complications will require “specialized long-term cardiovascular follow-up,” Dr. Mehta and associates said. “In women with a high-risk pregnancy, a cardio-obstetrics team is essential to prevent maternal morbidity and mortality during the length of the pregnancy and post partum.”

“The release of this document demonstrates the AHA’s recognition of the importance of CVD in pregnancy-related death and their commitment to education and ensuring best practices in this field,” said Lisa M. Hollier, MD, past president of the American College of Obstetricians and Gynecologists and chief medical officer at Texas Children’s Health Plan, Bellaire.

“I think one of the most important outcomes from the release of this scientific statement from AHA will be increased implementation of cardio-obstetrics teams,” she said in an interview.

“In the United States, cardiovascular disease and cardiomyopathy together are now the leading cause of death in pregnancy and the postpartum period, and constitute 26.5% of pregnancy-related deaths, with higher rates of mortality among women of color and women with lower incomes,” she said. “The rising trend in cardiovascular-related maternal deaths appears to be due to acquired, not congenital, heart disease.”

During her tenure as president of ACOG, Dr. Hollier convened a task force on cardiovascular disease in pregnancy that developed guidance that outlines screening, diagnosis, and management of CVD for women from prepregnancy through post partum.

Dr. Hollier noted that COVID-19 emphasizes racial disparities for maternal mortality.

“Pregnant patients with comorbidities, like heart conditions, may be at increased risk for severe illness from COVID-19 – consistent with the general population with similar comorbidities,” she said. “And as we know, black women’s risk of dying from CVD-related pregnancy complications is 3.4 times higher than that of white women. During the COVID-19 pandemic, we are seeing these racial health disparities exacerbated.”

However, any pregnant patients should not hesitate to communicate with their health care providers despite the pandemic situation, Dr. Hollier emphasized. “Communication between a patient and her ob.gyn., cardiologist, or other clinician is even more critical now during the COVID-19 pandemic. We’re hearing reports that patients who are experiencing symptoms or those with known cardiac conditions are avoiding the hospital and delaying or not seeking necessary treatment. This has the very real possibility of worsening the devastating maternal mortality crisis that we’re already experiencing in this country.”

To help overcome barriers to treatment, “collaboration between ob.gyns. and cardiologists, such as the cardio-obstetrics team or pregnancy heart team, is critical,” said Dr. Hollier. “These collaborative teams with a multidisciplinary approach can prospectively reduce the communication gaps across specialties when patients are seen separately. They can also improve the communication during care transitions such as between outpatient and inpatient care.


“In reviews of maternal deaths, we have found that there are often delays in diagnosis of heart conditions during and after pregnancy,” Dr. Hollier added. “Most maternal deaths from CVD are due to either undiagnosed cardiovascular disease or new-onset cardiomyopathy. ACOG recommends that all women be assessed for cardiovascular disease in the antepartum and postpartum periods using a recently developed algorithm,” she said. “Women who have known CVD and women who have concerning symptoms should have a consultation with this team. With increased awareness and screening, women can receive the additional care that they need.

“Because management of cardiac conditions in pregnancy is so complex, it is important to ensure that women receive care with teams and in facilities that have appropriate resources,” explained Dr. Hollier. “Women with known heart disease should see a cardiologist prior to pregnancy and receive prepregnancy counseling,” as noted in the AHA statement. “Patients determined to have moderate and high-risk CVD should be managed during pregnancy, delivery, and post partum in a medical center that is able to provide a higher level of care, including a cardio-obstetrics team.”

Early recognition of cardiovascular conditions is essential to help manage care and reduce risks to mother and baby, said Dr. Hollier. “Identification before a woman becomes pregnant means the patient’s care can be properly managed throughout the pregnancy and a detailed delivery plan can be developed through shared decision making between the patient and provider. We must think of heart disease as a possibility in every pregnant or postpartum patient we see to detect and treat at-risk mothers,” she said.

Additional research should focus on identifying risk factors prior to pregnancy, said Dr. Hollier. “There are often delays in recognizing symptoms during pregnancy and post partum, particularly for black women. We need data to understand which protocols are best to identify heart disease,”

Dr. Hollier had no financial conflicts to disclose. The authors of the AHA statement had no financial conflicts to disclose. The scientific statement was produced on behalf of the American Heart Association Council on Clinical Cardiology; Council on Atherosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and the Stroke Council.

SOURCE: Mehta LS et al. Circulation. 2020 May 4. doi: 10.1161/CIR.0000000000000772.

Women with cardiovascular conditions who are planning pregnancy should be assessed and managed by a multidisciplinary team to ensure the best outcomes, according to a statement from the American Heart Association.

©American Heart Association

Cardiovascular disease (CVD) remains the leading cause of pregnancy-related mortality in the United States, and accounted for approximately 17 deaths per 100,000 live births in 2015, wrote Laxmi S. Mehta, MD, of The Ohio State University, Columbus, and colleagues.

Ideally, a woman with CVD at the time of pregnancy should be managed by a multidisciplinary cardio-obstetrics team that can assess cardiovascular risk, obstetric risk, and fetal risk throughout pregnancy, delivery, and up to a year post partum. The team should develop a shared strategy to promote best outcomes, according to the statement. The cardio-obstetrics team may include obstetricians, cardiologists, anesthesiologists, maternal-fetal medicine specialists, geneticists, neurologists, nurses, and pharmacists, according to the statement.

Women with preexisting CVD should receive counseling about maternal and fetal risks before conception, if possible, to involve the women in shared decision-making and to develop strategies for each stage of pregnancy and delivery, Dr. Mehta and associates said. Such counseling should include a review of all medications and assessment of risk factors.

However, some women present already in the early stages of pregnancy even with severe conditions such as pulmonary arterial hypertension, severe ventricular dysfunction, severe left-sided heart obstruction, and significant aortic dilatation with underlying connective tissue disease. Women with these conditions often are counseled to avoid pregnancy, but if they already are pregnant, a high-risk cardio-obstetrics team will need to work together to discover the best strategies going forward to mitigate risk, Dr. Mehta and associates said.

Common CVD conditions that affect pregnancy include hypertensive disorders, notably preeclampsia, defined as systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg in women after 20 weeks of gestation whose blood pressure was normal prior to pregnancy. A management strategy to reduce the risk of pregnancy-related complications from hypertension includes healthy lifestyle behaviors such as exercise, nutrition, and smoking cessation, according to the statement. However, patients with severe hypertension may require intravenous labetalol or hydralazine. The statement gives more information about handling preeclampsia with pulmonary edema, and prevention of eclampsia and treatment of seizures.

It is important to recognize that severe hypertension or superimposed preeclampsia may occur for the first time post partum. Early ambulatory visits in the first 1-2 weeks are sensible. Medications may be needed to keep a systolic blood pressure not higher than 150 mm Hg and a diastolic blood pressure not higher than 100 mm Hg, Dr. Mehta and associates said.

According to the statement, severe hypertriglyceridemia and familial hypercholesterolemia are the two most common conditions in which lipids should be addressed during pregnancy, with consideration of the fetal risks associated with certain medications.

“Statins are contraindicated during pregnancy, and all women who are on any lipid-lowering agents should review with their physician the safety of treatment during pregnancy and whether to discontinue treatment before pregnancy,” according to the statement. A heart-healthy lifestyle can help improve lipid profiles in all pregnant patients, Dr. Mehta and associates said. Patients with extremely high triglycerides above 500 mg/dL are at risk of pancreatitis and “may benefit from pharmacological agents (omega-3 fatty acids with or without fenofibrate or gemfibrozil) during the second trimester,” they noted. Pregnant women with familial hypercholesterolemia might take bile acid sequestrants, or as a last resort, low-density lipoprotein apheresis.

Other conditions calling for a multidisciplinary cardio-obstetric approach include preexisting coronary artery disease, cardiomyopathies, arrhythmias, valvular heart disease, cerebrovascular disease, and deep venous thrombosis, according to the statement, which provides information about the risks, diagnosis, and management.

When it is time for delivery, spontaneous labor and vaginal birth are preferable for most women with heart disease, as cesarean delivery is associated with increased risk of infection, thrombotic complications, and blood loss, according to the statement.

Women with CVD and associated complications will require “specialized long-term cardiovascular follow-up,” Dr. Mehta and associates said. “In women with a high-risk pregnancy, a cardio-obstetrics team is essential to prevent maternal morbidity and mortality during the length of the pregnancy and post partum.”

“The release of this document demonstrates the AHA’s recognition of the importance of CVD in pregnancy-related death and their commitment to education and ensuring best practices in this field,” said Lisa M. Hollier, MD, past president of the American College of Obstetricians and Gynecologists and chief medical officer at Texas Children’s Health Plan, Bellaire.

“I think one of the most important outcomes from the release of this scientific statement from AHA will be increased implementation of cardio-obstetrics teams,” she said in an interview.

“In the United States, cardiovascular disease and cardiomyopathy together are now the leading cause of death in pregnancy and the postpartum period, and constitute 26.5% of pregnancy-related deaths, with higher rates of mortality among women of color and women with lower incomes,” she said. “The rising trend in cardiovascular-related maternal deaths appears to be due to acquired, not congenital, heart disease.”

During her tenure as president of ACOG, Dr. Hollier convened a task force on cardiovascular disease in pregnancy that developed guidance that outlines screening, diagnosis, and management of CVD for women from prepregnancy through post partum.

Dr. Hollier noted that COVID-19 emphasizes racial disparities for maternal mortality.

“Pregnant patients with comorbidities, like heart conditions, may be at increased risk for severe illness from COVID-19 – consistent with the general population with similar comorbidities,” she said. “And as we know, black women’s risk of dying from CVD-related pregnancy complications is 3.4 times higher than that of white women. During the COVID-19 pandemic, we are seeing these racial health disparities exacerbated.”

However, any pregnant patients should not hesitate to communicate with their health care providers despite the pandemic situation, Dr. Hollier emphasized. “Communication between a patient and her ob.gyn., cardiologist, or other clinician is even more critical now during the COVID-19 pandemic. We’re hearing reports that patients who are experiencing symptoms or those with known cardiac conditions are avoiding the hospital and delaying or not seeking necessary treatment. This has the very real possibility of worsening the devastating maternal mortality crisis that we’re already experiencing in this country.”

To help overcome barriers to treatment, “collaboration between ob.gyns. and cardiologists, such as the cardio-obstetrics team or pregnancy heart team, is critical,” said Dr. Hollier. “These collaborative teams with a multidisciplinary approach can prospectively reduce the communication gaps across specialties when patients are seen separately. They can also improve the communication during care transitions such as between outpatient and inpatient care.


“In reviews of maternal deaths, we have found that there are often delays in diagnosis of heart conditions during and after pregnancy,” Dr. Hollier added. “Most maternal deaths from CVD are due to either undiagnosed cardiovascular disease or new-onset cardiomyopathy. ACOG recommends that all women be assessed for cardiovascular disease in the antepartum and postpartum periods using a recently developed algorithm,” she said. “Women who have known CVD and women who have concerning symptoms should have a consultation with this team. With increased awareness and screening, women can receive the additional care that they need.

“Because management of cardiac conditions in pregnancy is so complex, it is important to ensure that women receive care with teams and in facilities that have appropriate resources,” explained Dr. Hollier. “Women with known heart disease should see a cardiologist prior to pregnancy and receive prepregnancy counseling,” as noted in the AHA statement. “Patients determined to have moderate and high-risk CVD should be managed during pregnancy, delivery, and post partum in a medical center that is able to provide a higher level of care, including a cardio-obstetrics team.”

Early recognition of cardiovascular conditions is essential to help manage care and reduce risks to mother and baby, said Dr. Hollier. “Identification before a woman becomes pregnant means the patient’s care can be properly managed throughout the pregnancy and a detailed delivery plan can be developed through shared decision making between the patient and provider. We must think of heart disease as a possibility in every pregnant or postpartum patient we see to detect and treat at-risk mothers,” she said.

Additional research should focus on identifying risk factors prior to pregnancy, said Dr. Hollier. “There are often delays in recognizing symptoms during pregnancy and post partum, particularly for black women. We need data to understand which protocols are best to identify heart disease,”

Dr. Hollier had no financial conflicts to disclose. The authors of the AHA statement had no financial conflicts to disclose. The scientific statement was produced on behalf of the American Heart Association Council on Clinical Cardiology; Council on Atherosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and the Stroke Council.

SOURCE: Mehta LS et al. Circulation. 2020 May 4. doi: 10.1161/CIR.0000000000000772.

Women with cardiovascular conditions who are planning pregnancy should be assessed and managed by a multidisciplinary team to ensure the best outcomes, according to a statement from the American Heart Association.

©American Heart Association

Cardiovascular disease (CVD) remains the leading cause of pregnancy-related mortality in the United States, and accounted for approximately 17 deaths per 100,000 live births in 2015, wrote Laxmi S. Mehta, MD, of The Ohio State University, Columbus, and colleagues.

Ideally, a woman with CVD at the time of pregnancy should be managed by a multidisciplinary cardio-obstetrics team that can assess cardiovascular risk, obstetric risk, and fetal risk throughout pregnancy, delivery, and up to a year post partum. The team should develop a shared strategy to promote best outcomes, according to the statement. The cardio-obstetrics team may include obstetricians, cardiologists, anesthesiologists, maternal-fetal medicine specialists, geneticists, neurologists, nurses, and pharmacists, according to the statement.

Women with preexisting CVD should receive counseling about maternal and fetal risks before conception, if possible, to involve the women in shared decision-making and to develop strategies for each stage of pregnancy and delivery, Dr. Mehta and associates said. Such counseling should include a review of all medications and assessment of risk factors.

However, some women present already in the early stages of pregnancy even with severe conditions such as pulmonary arterial hypertension, severe ventricular dysfunction, severe left-sided heart obstruction, and significant aortic dilatation with underlying connective tissue disease. Women with these conditions often are counseled to avoid pregnancy, but if they already are pregnant, a high-risk cardio-obstetrics team will need to work together to discover the best strategies going forward to mitigate risk, Dr. Mehta and associates said.

Common CVD conditions that affect pregnancy include hypertensive disorders, notably preeclampsia, defined as systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg in women after 20 weeks of gestation whose blood pressure was normal prior to pregnancy. A management strategy to reduce the risk of pregnancy-related complications from hypertension includes healthy lifestyle behaviors such as exercise, nutrition, and smoking cessation, according to the statement. However, patients with severe hypertension may require intravenous labetalol or hydralazine. The statement gives more information about handling preeclampsia with pulmonary edema, and prevention of eclampsia and treatment of seizures.

It is important to recognize that severe hypertension or superimposed preeclampsia may occur for the first time post partum. Early ambulatory visits in the first 1-2 weeks are sensible. Medications may be needed to keep a systolic blood pressure not higher than 150 mm Hg and a diastolic blood pressure not higher than 100 mm Hg, Dr. Mehta and associates said.

According to the statement, severe hypertriglyceridemia and familial hypercholesterolemia are the two most common conditions in which lipids should be addressed during pregnancy, with consideration of the fetal risks associated with certain medications.

“Statins are contraindicated during pregnancy, and all women who are on any lipid-lowering agents should review with their physician the safety of treatment during pregnancy and whether to discontinue treatment before pregnancy,” according to the statement. A heart-healthy lifestyle can help improve lipid profiles in all pregnant patients, Dr. Mehta and associates said. Patients with extremely high triglycerides above 500 mg/dL are at risk of pancreatitis and “may benefit from pharmacological agents (omega-3 fatty acids with or without fenofibrate or gemfibrozil) during the second trimester,” they noted. Pregnant women with familial hypercholesterolemia might take bile acid sequestrants, or as a last resort, low-density lipoprotein apheresis.

Other conditions calling for a multidisciplinary cardio-obstetric approach include preexisting coronary artery disease, cardiomyopathies, arrhythmias, valvular heart disease, cerebrovascular disease, and deep venous thrombosis, according to the statement, which provides information about the risks, diagnosis, and management.

When it is time for delivery, spontaneous labor and vaginal birth are preferable for most women with heart disease, as cesarean delivery is associated with increased risk of infection, thrombotic complications, and blood loss, according to the statement.

Women with CVD and associated complications will require “specialized long-term cardiovascular follow-up,” Dr. Mehta and associates said. “In women with a high-risk pregnancy, a cardio-obstetrics team is essential to prevent maternal morbidity and mortality during the length of the pregnancy and post partum.”

“The release of this document demonstrates the AHA’s recognition of the importance of CVD in pregnancy-related death and their commitment to education and ensuring best practices in this field,” said Lisa M. Hollier, MD, past president of the American College of Obstetricians and Gynecologists and chief medical officer at Texas Children’s Health Plan, Bellaire.

“I think one of the most important outcomes from the release of this scientific statement from AHA will be increased implementation of cardio-obstetrics teams,” she said in an interview.

“In the United States, cardiovascular disease and cardiomyopathy together are now the leading cause of death in pregnancy and the postpartum period, and constitute 26.5% of pregnancy-related deaths, with higher rates of mortality among women of color and women with lower incomes,” she said. “The rising trend in cardiovascular-related maternal deaths appears to be due to acquired, not congenital, heart disease.”

During her tenure as president of ACOG, Dr. Hollier convened a task force on cardiovascular disease in pregnancy that developed guidance that outlines screening, diagnosis, and management of CVD for women from prepregnancy through post partum.

Dr. Hollier noted that COVID-19 emphasizes racial disparities for maternal mortality.

“Pregnant patients with comorbidities, like heart conditions, may be at increased risk for severe illness from COVID-19 – consistent with the general population with similar comorbidities,” she said. “And as we know, black women’s risk of dying from CVD-related pregnancy complications is 3.4 times higher than that of white women. During the COVID-19 pandemic, we are seeing these racial health disparities exacerbated.”

However, any pregnant patients should not hesitate to communicate with their health care providers despite the pandemic situation, Dr. Hollier emphasized. “Communication between a patient and her ob.gyn., cardiologist, or other clinician is even more critical now during the COVID-19 pandemic. We’re hearing reports that patients who are experiencing symptoms or those with known cardiac conditions are avoiding the hospital and delaying or not seeking necessary treatment. This has the very real possibility of worsening the devastating maternal mortality crisis that we’re already experiencing in this country.”

To help overcome barriers to treatment, “collaboration between ob.gyns. and cardiologists, such as the cardio-obstetrics team or pregnancy heart team, is critical,” said Dr. Hollier. “These collaborative teams with a multidisciplinary approach can prospectively reduce the communication gaps across specialties when patients are seen separately. They can also improve the communication during care transitions such as between outpatient and inpatient care.


“In reviews of maternal deaths, we have found that there are often delays in diagnosis of heart conditions during and after pregnancy,” Dr. Hollier added. “Most maternal deaths from CVD are due to either undiagnosed cardiovascular disease or new-onset cardiomyopathy. ACOG recommends that all women be assessed for cardiovascular disease in the antepartum and postpartum periods using a recently developed algorithm,” she said. “Women who have known CVD and women who have concerning symptoms should have a consultation with this team. With increased awareness and screening, women can receive the additional care that they need.

“Because management of cardiac conditions in pregnancy is so complex, it is important to ensure that women receive care with teams and in facilities that have appropriate resources,” explained Dr. Hollier. “Women with known heart disease should see a cardiologist prior to pregnancy and receive prepregnancy counseling,” as noted in the AHA statement. “Patients determined to have moderate and high-risk CVD should be managed during pregnancy, delivery, and post partum in a medical center that is able to provide a higher level of care, including a cardio-obstetrics team.”

Early recognition of cardiovascular conditions is essential to help manage care and reduce risks to mother and baby, said Dr. Hollier. “Identification before a woman becomes pregnant means the patient’s care can be properly managed throughout the pregnancy and a detailed delivery plan can be developed through shared decision making between the patient and provider. We must think of heart disease as a possibility in every pregnant or postpartum patient we see to detect and treat at-risk mothers,” she said.

Additional research should focus on identifying risk factors prior to pregnancy, said Dr. Hollier. “There are often delays in recognizing symptoms during pregnancy and post partum, particularly for black women. We need data to understand which protocols are best to identify heart disease,”

Dr. Hollier had no financial conflicts to disclose. The authors of the AHA statement had no financial conflicts to disclose. The scientific statement was produced on behalf of the American Heart Association Council on Clinical Cardiology; Council on Atherosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and the Stroke Council.

SOURCE: Mehta LS et al. Circulation. 2020 May 4. doi: 10.1161/CIR.0000000000000772.

The meteoric rise in the number of test-positive and clinical cases of COVID-19 because of infection with the SARS coronavirus (SARS-CoV-2) in states and cities across the United States has added urgency to the efforts to develop protocols for hospital triage, admission, labor and delivery management, and other aspects of obstetrical care.

Emerging data suggest that, while SARS-CoV-2 is less lethal overall than the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) proved to be, it is significantly more contagious. Although a severe disease, the limited worldwide data so far available (as of early May) do not indicate that pregnant women are at greater risk of severe disease, compared with the general population. However, there remains a critical need for data on maternal and perinatal outcomes in women infected with SARS-CoV-2.

Multiple physiological changes in pregnancy, from reduced cell-based immune competence to changes in respiratory tract and pulmonary function – e.g., edema of the respiratory tract, increases in secretions and oxygen consumption, elevation of the diaphragm, and decrease in functional residual capacity – have historically contributed to worse obstetric outcomes in pregnant women who have had viral pneumonias. Furthermore, limited published experience with COVID-19 in China suggests worse perinatal outcomes in some affected pregnancies, including prematurity and perinatal death.

With evolution of the pandemic and accumulation of experience, it is expected that data-driven guidelines on assessment and management of infected pregnant women will contribute to improved maternal and perinatal outcomes. What is clear now, however, is that, without protecting the health of obstetricians and other health care workers, urgently needed gains in patient outcomes will not be realized.

Here are my recommendations, based on a currently limited body of literature on COVID-19 and other communicable viral respiratory disorders, as well my experience in the greater Detroit area, a COVID-19 hot spot.
 

Preparing for hospital evaluation and admission

The obstetric triage or labor and delivery (L&D) unit should be notified prior to the arrival of a patient suspected of or known to be infected with the virus. This will minimize staff exposure and allow sufficient time to prepare appropriate accommodations, equipment, and supplies for the patient’s care. Hospital infection control should be promptly notified by L&D of the expected arrival of such a patient. Placement ideally should be in a negative-pressure room, which allows outside air to flow into the room but prevents contaminated air from escaping. In the absence of a negative-pressure room, an infection isolation area should be utilized.

The patient and one accompanying support individual should wear either medical-grade masks brought from home or supplied upon entry to the hospital or homemade masks or bandanas. This will reduce the risk of viral transmission to hospital workers and other individuals encountered in the hospital prior to arriving in L&D. An ideal setup is to have separate entry areas, access corridors, and elevators for patients known or suspected to have COVID-19 infection. The patient and visitor should be expeditiously escorted to the prepared area for evaluation. Patients who are not known or suspected to be infected ideally should be tested.
 

Screening of patients & support individuals

Proper screening of patients and support individuals is critical to protecting both patients and staff in the L&D unit. This should include an expanded questionnaire that asks about disturbances of smell and taste and GI symptoms like loss of appetite – not only the more commonly queried symptoms of fever, shortness of breath, coughing, and exposure to someone who may have been ill.

Recent studies regarding presenting symptoms cast significant doubt, in fact, on the validity of patients with “asymptomatic COVID-19.” Over 15% of patients with confirmed infection in one published case series had solely GI symptoms and almost all had some digestive symptoms, for example, and almost 90% in another study had absent or reduced sense of smell and/or taste.^1,2 In fact, the use of the term “paucisymptomatic” rather than “asymptomatic” may be most appropriate.

Support individuals also should undergo temperature screening, ideally with laser noncontact thermometers on entry to the hospital or triage.
 

Visitor policy

The number of visitors/support individuals should be kept to a minimum to reduce transmission risk. The actual number will be determined by hospital or state policy, but up to one visitor in the labor room appears reasonable. Very strong individual justification should be required to exceed this threshold! The visitor should not only be screened for an expanded list of symptoms, but they also should be queried for underlying illnesses (e.g., diabetes, cardiovascular disease, significant lung disease, undergoing cancer therapy) as well as for age over 65 years, each of which increase the chances of severe COVID-19 disease should infection occur. The visitor should be informed of such risks and, especially when accompanying a patient with known or suspected COVID-19, provided the option of voluntarily revoking their visitor status. A visitor with known or suspected COVID-19 infection based on testing or screening should not be allowed into the L&D unit.

In addition, institutions may be considered to have obligations to the visitor/support person beyond screening. These include instructions in proper mask usage, hand washing, and limiting the touching of surfaces to lower infection risk.

“Visitor relays” where one visitor replaces another should be strongly discouraged. Visitors should similarly not be allowed to wander around the hospital (to use phones, for instance); transiting back and forth to obtain food and coffee should be kept to a strict minimum. For visitors accompanying COVID-19–-infected women, “visitor’s plates” provided by the hospital at reasonable cost is a much-preferred arrangement for obtaining meals during the course of the hospital stay. In addition, visitors should be sent out of the room during the performance of aerosolizing procedures.
 

Labor and delivery management

The successful management of patients with COVID-19 requires a rigorous infection control protocol informed by guidelines from national entities, such as the Centers for Disease Control and Prevention, the Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists, and by state health departments when available.

Strict limits on the number of obstetricians and other health care workers (HCWs) entering the patient’s room should be enforced and documented to minimize risk to the HCWs attending to patients who have a positive diagnosis or who are under investigation. Only in cases of demonstrable clinical benefit should repeat visits by the same or additional HCWs be permitted. Conventional and electronic tablets present an excellent opportunity for patient follow-up visits without room entry. In our institution, this has been successfully piloted in nonpregnant patients. Obstetricians and others caring for obstetrical patients – especially those who are infected or under investigation for infection – should always wear a properly fitted N95 mask.

Because patients with COVID-19 may have or go on to develop a constellation of organ abnormalities (e.g., cardiovascular, renal, pulmonary), it is vital that a standardized panel of baseline laboratory studies be developed for pregnant patients. This will minimize the need for repeated blood draws and other testing which may increase HCW exposure.

A negative screen based on nonreport of symptoms, lack of temperature elevation, and reported nonexposure to individuals with COVID-19 symptoms still has limitations in terms of disease detection. A recent report from a tertiary care hospital in New York City found that close to one-third of pregnant patients with confirmed COVID-19 admitted over a 2-week period had no viral symptoms or instructive history on initial admission.³ This is consistent with our clinical experience. Most importantly, therefore, routine quantitative reverse transcription polymerase chain reaction testing should be performed on all patients admitted to the L&D unit.

Given the reported variability in the accuracy of polymerase chain reaction testing induced by variable effectiveness of sampling techniques, stage of infection, and inherent test accuracy issues, symptomatic patients with a negative test should first obtain clearance from infectious disease specialists before isolation precautions are discontinued. Repeat testing in 24 hours, including testing of multiple sites, may subsequently yield a positive result in persistently symptomatic patients.
 

Intrapartum management

As much as possible, standard obstetric indications should guide the timing and route of delivery. In the case of a COVID-19–positive patient or a patient under investigation, nonobstetric factors may bear heavily on decision making, and management flexibility is of great value. For example, in cases of severe or critical disease status, evidence suggests that early delivery regardless of gestational age can improve maternal oxygenation; this supports the liberal use of C-sections in these circumstances. In addition, shortening labor length as well as duration of hospitalization may be expected to reduce the risk of transmission to HCWs, other staff, and other patients.

High rates of cesarean delivery unsurprisingly have been reported thus far: One review of 108 case reports and series of test-positive COVID-19 pregnancies found a 92% C-section rate, and another review and meta-analysis of studies of SARS, MERS, and COVID-19 during pregnancy similarly found that the majority of patients – 84% across all coronavirus infections and 91% in COVID-19 pregnancies – were delivered by C-section.4,5 Given these high rates of cesarean deliveries, the early placement of neuraxial anesthesia while the patient is stable appears to be prudent and obviates the need for intubation, the latter of which is associated with increased aerosol generation and increased virus transmission risk.

Strict protocols for the optimal protection of staff should be observed, including proper personal protective equipment (PPE) protection. Protocols have been detailed in various guidelines and publications; they include the wearing of shoe covers, gowns, N95 masks, goggles, face shields, and two layers of gloves.

For institutions that currently do not offer routine COVID-19 testing to pregnant patients – especially those in areas of outbreaks – N95 masks and eye protection should still be provided to all HCWs involved in the intrapartum management of untested asymptomatic patients, particularly those in the active phase of labor. This protection is justified given the limitations of symptom- and history-based screening and the not-uncommon experience of the patient with a negative screen who subsequently develops the clinical syndrome.

Obstetric management of labor requires close patient contact that potentially elevates the risk of contamination and infection. During the active stage of labor, patient shouting, rapid mouth breathing, and other behaviors inherent to labor all increase the risk of aerosolization of oronasal secretions. In addition, nasal-prong oxygen administration is believed to independently increase the risk of aerosolization of secretions. The casual practice of nasal oxygen application should thus be discontinued and, where felt to be absolutely necessary, a mask should be worn on top of the prongs.

Regarding operative delivery, each participating obstetric surgeon should observe guidelines and recommendations of governing national organizations and professional groups – including the American College of Surgeons – regarding the safe conduct of operations on patients with COVID-19. Written guidelines should be tailored as needed to the performance of C-sections and readily available in L&D. Drills and simulations are generally valuable, and expertise and support should always be available in the labor room to assist with donning and doffing of PPE.
 

Postpartum care

Expeditious separation of the COVID-19–positive mother from her infant is recommended, including avoidance of delayed cord clamping because of insufficient evidence of benefit to the infant. Insufficient evidence exists to support vertical transmission, but the possibility of maternal-infant transmission is clinically accepted based on small case reports of infection in a neonate at 30 hours of life and in infants of mothers with suspected or confirmed COVID-19.6,7 Accordingly, it is recommended that the benefit of early infant separation should be discussed with the mother. If approved, the infant should be kept in a separate isolation area and observed.

There is no evidence of breast milk transmission of the virus. For those electing to breastfeed, the patient should be provided with a breast pump to express and store the milk for subsequent bottle feeding. For mothers who elect to room in with the infant, a separation distance of 6 feet is recommended with an intervening barrier curtain. For COVID-19–positive mothers who elect breastfeeding, meticulous hand and face washing, continuous wearing of a mask, and cleansing of the breast prior to feeding needs to be maintained.

Restrictive visiting policies of no more than one visitor should be maintained. For severely or critically ill patients with COVID-19, it has been suggested that no visitors be allowed. As with other hospitalizations of COVID-19 patients, the HCW contact should be kept at a justifiable minimum to reduce the risk of transmission.
 

Protecting the obstetrician and other HCWs

Protecting the health of obstetricians and other HCWs is central to any successful strategy to fight the COVID-19 epidemic. For the individual obstetrician, careful attention to national and local hospital guidelines is required as these are rapidly evolving.

Physicians and their leadership must maintain an ongoing dialogue with hospital leadership to continually upgrade and optimize infection prevention and control measures, and to uphold best practices. The experience in Wuhan, China, illustrates the effectiveness of the proper use of PPE along with population control measures to reduce infections in HCWs. Prior to understanding the mechanism of virus transmission and using protective equipment, infection rates of 3%-29% were reported among HCWs. With the meticulous utilization of mitigation strategies and population control measures – including consistent use of PPE – the rate of infection of HCWs reportedly fell to zero.

In outpatient offices, all staff and HCWs should wear masks at all times and engage in social distancing and in frequent hand sanitization. Patients should be strongly encouraged to wear masks during office visits and on all other occasions when they will be in physical proximity to other individuals outside of the home.

Reports from epidemic areas describe transmission from household sources as a significant cause of HCW infection. The information emphasizes the need for ongoing vigilance and attention to sanitization measures even when at home with one’s family. An additional benefit is reduced risk of transmission from HCWs to family members.

Dr. Bahado-Singh is professor and chair of obstetrics and gynecology at Oakland University, Rochester, Mich., and health system chair for obstetrics and gynecology at Beaumont Health System.

References

1. Luo S et al. Clin Gastroenterol Hepatol. 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.043.

2. Lechien JR et al. Eur Arch Otorhinolaryngol. 2020 Apr 6. doi: 10.1007/s00405-020-05965-1.

3. Breslin N et al. Am J Obstet Gynecol MFM. 2020 Apr 9. doi: 10.1016/j.ajogmf.2020.100118.

4. Zaigham M, Andersson O. Acta Obstet Gynecol Scand. 2020 Apr 7. doi: 10.1111/aogs.13867.

5. Di Mascio D et al. Am J Obstet Gynecol MFM. 2020 Mar 25. doi: 10.1016/j.ajogmf.2020.100107.

6. Ital J. Pediatr 2020;46(1) doi: 10.1186/s13052-020-0820-x. 

7. Int J Gynaecol Obstet. 2020;149(2):130-6. 

*This article was updated 5/6/2020. 

The meteoric rise in the number of test-positive and clinical cases of COVID-19 because of infection with the SARS coronavirus (SARS-CoV-2) in states and cities across the United States has added urgency to the efforts to develop protocols for hospital triage, admission, labor and delivery management, and other aspects of obstetrical care.

Emerging data suggest that, while SARS-CoV-2 is less lethal overall than the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) proved to be, it is significantly more contagious. Although a severe disease, the limited worldwide data so far available (as of early May) do not indicate that pregnant women are at greater risk of severe disease, compared with the general population. However, there remains a critical need for data on maternal and perinatal outcomes in women infected with SARS-CoV-2.

Multiple physiological changes in pregnancy, from reduced cell-based immune competence to changes in respiratory tract and pulmonary function – e.g., edema of the respiratory tract, increases in secretions and oxygen consumption, elevation of the diaphragm, and decrease in functional residual capacity – have historically contributed to worse obstetric outcomes in pregnant women who have had viral pneumonias. Furthermore, limited published experience with COVID-19 in China suggests worse perinatal outcomes in some affected pregnancies, including prematurity and perinatal death.

With evolution of the pandemic and accumulation of experience, it is expected that data-driven guidelines on assessment and management of infected pregnant women will contribute to improved maternal and perinatal outcomes. What is clear now, however, is that, without protecting the health of obstetricians and other health care workers, urgently needed gains in patient outcomes will not be realized.

Here are my recommendations, based on a currently limited body of literature on COVID-19 and other communicable viral respiratory disorders, as well my experience in the greater Detroit area, a COVID-19 hot spot.
 

Preparing for hospital evaluation and admission

The obstetric triage or labor and delivery (L&D) unit should be notified prior to the arrival of a patient suspected of or known to be infected with the virus. This will minimize staff exposure and allow sufficient time to prepare appropriate accommodations, equipment, and supplies for the patient’s care. Hospital infection control should be promptly notified by L&D of the expected arrival of such a patient. Placement ideally should be in a negative-pressure room, which allows outside air to flow into the room but prevents contaminated air from escaping. In the absence of a negative-pressure room, an infection isolation area should be utilized.

The patient and one accompanying support individual should wear either medical-grade masks brought from home or supplied upon entry to the hospital or homemade masks or bandanas. This will reduce the risk of viral transmission to hospital workers and other individuals encountered in the hospital prior to arriving in L&D. An ideal setup is to have separate entry areas, access corridors, and elevators for patients known or suspected to have COVID-19 infection. The patient and visitor should be expeditiously escorted to the prepared area for evaluation. Patients who are not known or suspected to be infected ideally should be tested.
 

Screening of patients & support individuals

Proper screening of patients and support individuals is critical to protecting both patients and staff in the L&D unit. This should include an expanded questionnaire that asks about disturbances of smell and taste and GI symptoms like loss of appetite – not only the more commonly queried symptoms of fever, shortness of breath, coughing, and exposure to someone who may have been ill.

Recent studies regarding presenting symptoms cast significant doubt, in fact, on the validity of patients with “asymptomatic COVID-19.” Over 15% of patients with confirmed infection in one published case series had solely GI symptoms and almost all had some digestive symptoms, for example, and almost 90% in another study had absent or reduced sense of smell and/or taste.^1,2 In fact, the use of the term “paucisymptomatic” rather than “asymptomatic” may be most appropriate.

Support individuals also should undergo temperature screening, ideally with laser noncontact thermometers on entry to the hospital or triage.
 

Visitor policy

The number of visitors/support individuals should be kept to a minimum to reduce transmission risk. The actual number will be determined by hospital or state policy, but up to one visitor in the labor room appears reasonable. Very strong individual justification should be required to exceed this threshold! The visitor should not only be screened for an expanded list of symptoms, but they also should be queried for underlying illnesses (e.g., diabetes, cardiovascular disease, significant lung disease, undergoing cancer therapy) as well as for age over 65 years, each of which increase the chances of severe COVID-19 disease should infection occur. The visitor should be informed of such risks and, especially when accompanying a patient with known or suspected COVID-19, provided the option of voluntarily revoking their visitor status. A visitor with known or suspected COVID-19 infection based on testing or screening should not be allowed into the L&D unit.

In addition, institutions may be considered to have obligations to the visitor/support person beyond screening. These include instructions in proper mask usage, hand washing, and limiting the touching of surfaces to lower infection risk.

“Visitor relays” where one visitor replaces another should be strongly discouraged. Visitors should similarly not be allowed to wander around the hospital (to use phones, for instance); transiting back and forth to obtain food and coffee should be kept to a strict minimum. For visitors accompanying COVID-19–-infected women, “visitor’s plates” provided by the hospital at reasonable cost is a much-preferred arrangement for obtaining meals during the course of the hospital stay. In addition, visitors should be sent out of the room during the performance of aerosolizing procedures.
 

Labor and delivery management

The successful management of patients with COVID-19 requires a rigorous infection control protocol informed by guidelines from national entities, such as the Centers for Disease Control and Prevention, the Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists, and by state health departments when available.

Strict limits on the number of obstetricians and other health care workers (HCWs) entering the patient’s room should be enforced and documented to minimize risk to the HCWs attending to patients who have a positive diagnosis or who are under investigation. Only in cases of demonstrable clinical benefit should repeat visits by the same or additional HCWs be permitted. Conventional and electronic tablets present an excellent opportunity for patient follow-up visits without room entry. In our institution, this has been successfully piloted in nonpregnant patients. Obstetricians and others caring for obstetrical patients – especially those who are infected or under investigation for infection – should always wear a properly fitted N95 mask.

Because patients with COVID-19 may have or go on to develop a constellation of organ abnormalities (e.g., cardiovascular, renal, pulmonary), it is vital that a standardized panel of baseline laboratory studies be developed for pregnant patients. This will minimize the need for repeated blood draws and other testing which may increase HCW exposure.

A negative screen based on nonreport of symptoms, lack of temperature elevation, and reported nonexposure to individuals with COVID-19 symptoms still has limitations in terms of disease detection. A recent report from a tertiary care hospital in New York City found that close to one-third of pregnant patients with confirmed COVID-19 admitted over a 2-week period had no viral symptoms or instructive history on initial admission.³ This is consistent with our clinical experience. Most importantly, therefore, routine quantitative reverse transcription polymerase chain reaction testing should be performed on all patients admitted to the L&D unit.

Given the reported variability in the accuracy of polymerase chain reaction testing induced by variable effectiveness of sampling techniques, stage of infection, and inherent test accuracy issues, symptomatic patients with a negative test should first obtain clearance from infectious disease specialists before isolation precautions are discontinued. Repeat testing in 24 hours, including testing of multiple sites, may subsequently yield a positive result in persistently symptomatic patients.
 

Intrapartum management

As much as possible, standard obstetric indications should guide the timing and route of delivery. In the case of a COVID-19–positive patient or a patient under investigation, nonobstetric factors may bear heavily on decision making, and management flexibility is of great value. For example, in cases of severe or critical disease status, evidence suggests that early delivery regardless of gestational age can improve maternal oxygenation; this supports the liberal use of C-sections in these circumstances. In addition, shortening labor length as well as duration of hospitalization may be expected to reduce the risk of transmission to HCWs, other staff, and other patients.

High rates of cesarean delivery unsurprisingly have been reported thus far: One review of 108 case reports and series of test-positive COVID-19 pregnancies found a 92% C-section rate, and another review and meta-analysis of studies of SARS, MERS, and COVID-19 during pregnancy similarly found that the majority of patients – 84% across all coronavirus infections and 91% in COVID-19 pregnancies – were delivered by C-section.4,5 Given these high rates of cesarean deliveries, the early placement of neuraxial anesthesia while the patient is stable appears to be prudent and obviates the need for intubation, the latter of which is associated with increased aerosol generation and increased virus transmission risk.

Strict protocols for the optimal protection of staff should be observed, including proper personal protective equipment (PPE) protection. Protocols have been detailed in various guidelines and publications; they include the wearing of shoe covers, gowns, N95 masks, goggles, face shields, and two layers of gloves.

For institutions that currently do not offer routine COVID-19 testing to pregnant patients – especially those in areas of outbreaks – N95 masks and eye protection should still be provided to all HCWs involved in the intrapartum management of untested asymptomatic patients, particularly those in the active phase of labor. This protection is justified given the limitations of symptom- and history-based screening and the not-uncommon experience of the patient with a negative screen who subsequently develops the clinical syndrome.

Obstetric management of labor requires close patient contact that potentially elevates the risk of contamination and infection. During the active stage of labor, patient shouting, rapid mouth breathing, and other behaviors inherent to labor all increase the risk of aerosolization of oronasal secretions. In addition, nasal-prong oxygen administration is believed to independently increase the risk of aerosolization of secretions. The casual practice of nasal oxygen application should thus be discontinued and, where felt to be absolutely necessary, a mask should be worn on top of the prongs.

Regarding operative delivery, each participating obstetric surgeon should observe guidelines and recommendations of governing national organizations and professional groups – including the American College of Surgeons – regarding the safe conduct of operations on patients with COVID-19. Written guidelines should be tailored as needed to the performance of C-sections and readily available in L&D. Drills and simulations are generally valuable, and expertise and support should always be available in the labor room to assist with donning and doffing of PPE.
 

Postpartum care

Expeditious separation of the COVID-19–positive mother from her infant is recommended, including avoidance of delayed cord clamping because of insufficient evidence of benefit to the infant. Insufficient evidence exists to support vertical transmission, but the possibility of maternal-infant transmission is clinically accepted based on small case reports of infection in a neonate at 30 hours of life and in infants of mothers with suspected or confirmed COVID-19.6,7 Accordingly, it is recommended that the benefit of early infant separation should be discussed with the mother. If approved, the infant should be kept in a separate isolation area and observed.

There is no evidence of breast milk transmission of the virus. For those electing to breastfeed, the patient should be provided with a breast pump to express and store the milk for subsequent bottle feeding. For mothers who elect to room in with the infant, a separation distance of 6 feet is recommended with an intervening barrier curtain. For COVID-19–positive mothers who elect breastfeeding, meticulous hand and face washing, continuous wearing of a mask, and cleansing of the breast prior to feeding needs to be maintained.

Restrictive visiting policies of no more than one visitor should be maintained. For severely or critically ill patients with COVID-19, it has been suggested that no visitors be allowed. As with other hospitalizations of COVID-19 patients, the HCW contact should be kept at a justifiable minimum to reduce the risk of transmission.
 

Protecting the obstetrician and other HCWs

Protecting the health of obstetricians and other HCWs is central to any successful strategy to fight the COVID-19 epidemic. For the individual obstetrician, careful attention to national and local hospital guidelines is required as these are rapidly evolving.

Physicians and their leadership must maintain an ongoing dialogue with hospital leadership to continually upgrade and optimize infection prevention and control measures, and to uphold best practices. The experience in Wuhan, China, illustrates the effectiveness of the proper use of PPE along with population control measures to reduce infections in HCWs. Prior to understanding the mechanism of virus transmission and using protective equipment, infection rates of 3%-29% were reported among HCWs. With the meticulous utilization of mitigation strategies and population control measures – including consistent use of PPE – the rate of infection of HCWs reportedly fell to zero.

In outpatient offices, all staff and HCWs should wear masks at all times and engage in social distancing and in frequent hand sanitization. Patients should be strongly encouraged to wear masks during office visits and on all other occasions when they will be in physical proximity to other individuals outside of the home.

Reports from epidemic areas describe transmission from household sources as a significant cause of HCW infection. The information emphasizes the need for ongoing vigilance and attention to sanitization measures even when at home with one’s family. An additional benefit is reduced risk of transmission from HCWs to family members.

Dr. Bahado-Singh is professor and chair of obstetrics and gynecology at Oakland University, Rochester, Mich., and health system chair for obstetrics and gynecology at Beaumont Health System.

References

1. Luo S et al. Clin Gastroenterol Hepatol. 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.043.

2. Lechien JR et al. Eur Arch Otorhinolaryngol. 2020 Apr 6. doi: 10.1007/s00405-020-05965-1.

3. Breslin N et al. Am J Obstet Gynecol MFM. 2020 Apr 9. doi: 10.1016/j.ajogmf.2020.100118.

4. Zaigham M, Andersson O. Acta Obstet Gynecol Scand. 2020 Apr 7. doi: 10.1111/aogs.13867.

5. Di Mascio D et al. Am J Obstet Gynecol MFM. 2020 Mar 25. doi: 10.1016/j.ajogmf.2020.100107.

6. Ital J. Pediatr 2020;46(1) doi: 10.1186/s13052-020-0820-x. 

7. Int J Gynaecol Obstet. 2020;149(2):130-6. 

*This article was updated 5/6/2020. 

The meteoric rise in the number of test-positive and clinical cases of COVID-19 because of infection with the SARS coronavirus (SARS-CoV-2) in states and cities across the United States has added urgency to the efforts to develop protocols for hospital triage, admission, labor and delivery management, and other aspects of obstetrical care.

Emerging data suggest that, while SARS-CoV-2 is less lethal overall than the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) proved to be, it is significantly more contagious. Although a severe disease, the limited worldwide data so far available (as of early May) do not indicate that pregnant women are at greater risk of severe disease, compared with the general population. However, there remains a critical need for data on maternal and perinatal outcomes in women infected with SARS-CoV-2.

Multiple physiological changes in pregnancy, from reduced cell-based immune competence to changes in respiratory tract and pulmonary function – e.g., edema of the respiratory tract, increases in secretions and oxygen consumption, elevation of the diaphragm, and decrease in functional residual capacity – have historically contributed to worse obstetric outcomes in pregnant women who have had viral pneumonias. Furthermore, limited published experience with COVID-19 in China suggests worse perinatal outcomes in some affected pregnancies, including prematurity and perinatal death.

With evolution of the pandemic and accumulation of experience, it is expected that data-driven guidelines on assessment and management of infected pregnant women will contribute to improved maternal and perinatal outcomes. What is clear now, however, is that, without protecting the health of obstetricians and other health care workers, urgently needed gains in patient outcomes will not be realized.

Here are my recommendations, based on a currently limited body of literature on COVID-19 and other communicable viral respiratory disorders, as well my experience in the greater Detroit area, a COVID-19 hot spot.
 

Preparing for hospital evaluation and admission

The obstetric triage or labor and delivery (L&D) unit should be notified prior to the arrival of a patient suspected of or known to be infected with the virus. This will minimize staff exposure and allow sufficient time to prepare appropriate accommodations, equipment, and supplies for the patient’s care. Hospital infection control should be promptly notified by L&D of the expected arrival of such a patient. Placement ideally should be in a negative-pressure room, which allows outside air to flow into the room but prevents contaminated air from escaping. In the absence of a negative-pressure room, an infection isolation area should be utilized.

The patient and one accompanying support individual should wear either medical-grade masks brought from home or supplied upon entry to the hospital or homemade masks or bandanas. This will reduce the risk of viral transmission to hospital workers and other individuals encountered in the hospital prior to arriving in L&D. An ideal setup is to have separate entry areas, access corridors, and elevators for patients known or suspected to have COVID-19 infection. The patient and visitor should be expeditiously escorted to the prepared area for evaluation. Patients who are not known or suspected to be infected ideally should be tested.
 

Screening of patients & support individuals

Proper screening of patients and support individuals is critical to protecting both patients and staff in the L&D unit. This should include an expanded questionnaire that asks about disturbances of smell and taste and GI symptoms like loss of appetite – not only the more commonly queried symptoms of fever, shortness of breath, coughing, and exposure to someone who may have been ill.

Recent studies regarding presenting symptoms cast significant doubt, in fact, on the validity of patients with “asymptomatic COVID-19.” Over 15% of patients with confirmed infection in one published case series had solely GI symptoms and almost all had some digestive symptoms, for example, and almost 90% in another study had absent or reduced sense of smell and/or taste.^1,2 In fact, the use of the term “paucisymptomatic” rather than “asymptomatic” may be most appropriate.

Support individuals also should undergo temperature screening, ideally with laser noncontact thermometers on entry to the hospital or triage.
 

Visitor policy

The number of visitors/support individuals should be kept to a minimum to reduce transmission risk. The actual number will be determined by hospital or state policy, but up to one visitor in the labor room appears reasonable. Very strong individual justification should be required to exceed this threshold! The visitor should not only be screened for an expanded list of symptoms, but they also should be queried for underlying illnesses (e.g., diabetes, cardiovascular disease, significant lung disease, undergoing cancer therapy) as well as for age over 65 years, each of which increase the chances of severe COVID-19 disease should infection occur. The visitor should be informed of such risks and, especially when accompanying a patient with known or suspected COVID-19, provided the option of voluntarily revoking their visitor status. A visitor with known or suspected COVID-19 infection based on testing or screening should not be allowed into the L&D unit.

In addition, institutions may be considered to have obligations to the visitor/support person beyond screening. These include instructions in proper mask usage, hand washing, and limiting the touching of surfaces to lower infection risk.

“Visitor relays” where one visitor replaces another should be strongly discouraged. Visitors should similarly not be allowed to wander around the hospital (to use phones, for instance); transiting back and forth to obtain food and coffee should be kept to a strict minimum. For visitors accompanying COVID-19–-infected women, “visitor’s plates” provided by the hospital at reasonable cost is a much-preferred arrangement for obtaining meals during the course of the hospital stay. In addition, visitors should be sent out of the room during the performance of aerosolizing procedures.
 

Labor and delivery management

The successful management of patients with COVID-19 requires a rigorous infection control protocol informed by guidelines from national entities, such as the Centers for Disease Control and Prevention, the Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists, and by state health departments when available.

Strict limits on the number of obstetricians and other health care workers (HCWs) entering the patient’s room should be enforced and documented to minimize risk to the HCWs attending to patients who have a positive diagnosis or who are under investigation. Only in cases of demonstrable clinical benefit should repeat visits by the same or additional HCWs be permitted. Conventional and electronic tablets present an excellent opportunity for patient follow-up visits without room entry. In our institution, this has been successfully piloted in nonpregnant patients. Obstetricians and others caring for obstetrical patients – especially those who are infected or under investigation for infection – should always wear a properly fitted N95 mask.

Because patients with COVID-19 may have or go on to develop a constellation of organ abnormalities (e.g., cardiovascular, renal, pulmonary), it is vital that a standardized panel of baseline laboratory studies be developed for pregnant patients. This will minimize the need for repeated blood draws and other testing which may increase HCW exposure.

A negative screen based on nonreport of symptoms, lack of temperature elevation, and reported nonexposure to individuals with COVID-19 symptoms still has limitations in terms of disease detection. A recent report from a tertiary care hospital in New York City found that close to one-third of pregnant patients with confirmed COVID-19 admitted over a 2-week period had no viral symptoms or instructive history on initial admission.³ This is consistent with our clinical experience. Most importantly, therefore, routine quantitative reverse transcription polymerase chain reaction testing should be performed on all patients admitted to the L&D unit.

Given the reported variability in the accuracy of polymerase chain reaction testing induced by variable effectiveness of sampling techniques, stage of infection, and inherent test accuracy issues, symptomatic patients with a negative test should first obtain clearance from infectious disease specialists before isolation precautions are discontinued. Repeat testing in 24 hours, including testing of multiple sites, may subsequently yield a positive result in persistently symptomatic patients.
 

Intrapartum management

As much as possible, standard obstetric indications should guide the timing and route of delivery. In the case of a COVID-19–positive patient or a patient under investigation, nonobstetric factors may bear heavily on decision making, and management flexibility is of great value. For example, in cases of severe or critical disease status, evidence suggests that early delivery regardless of gestational age can improve maternal oxygenation; this supports the liberal use of C-sections in these circumstances. In addition, shortening labor length as well as duration of hospitalization may be expected to reduce the risk of transmission to HCWs, other staff, and other patients.

High rates of cesarean delivery unsurprisingly have been reported thus far: One review of 108 case reports and series of test-positive COVID-19 pregnancies found a 92% C-section rate, and another review and meta-analysis of studies of SARS, MERS, and COVID-19 during pregnancy similarly found that the majority of patients – 84% across all coronavirus infections and 91% in COVID-19 pregnancies – were delivered by C-section.4,5 Given these high rates of cesarean deliveries, the early placement of neuraxial anesthesia while the patient is stable appears to be prudent and obviates the need for intubation, the latter of which is associated with increased aerosol generation and increased virus transmission risk.

Strict protocols for the optimal protection of staff should be observed, including proper personal protective equipment (PPE) protection. Protocols have been detailed in various guidelines and publications; they include the wearing of shoe covers, gowns, N95 masks, goggles, face shields, and two layers of gloves.

For institutions that currently do not offer routine COVID-19 testing to pregnant patients – especially those in areas of outbreaks – N95 masks and eye protection should still be provided to all HCWs involved in the intrapartum management of untested asymptomatic patients, particularly those in the active phase of labor. This protection is justified given the limitations of symptom- and history-based screening and the not-uncommon experience of the patient with a negative screen who subsequently develops the clinical syndrome.

Obstetric management of labor requires close patient contact that potentially elevates the risk of contamination and infection. During the active stage of labor, patient shouting, rapid mouth breathing, and other behaviors inherent to labor all increase the risk of aerosolization of oronasal secretions. In addition, nasal-prong oxygen administration is believed to independently increase the risk of aerosolization of secretions. The casual practice of nasal oxygen application should thus be discontinued and, where felt to be absolutely necessary, a mask should be worn on top of the prongs.

Regarding operative delivery, each participating obstetric surgeon should observe guidelines and recommendations of governing national organizations and professional groups – including the American College of Surgeons – regarding the safe conduct of operations on patients with COVID-19. Written guidelines should be tailored as needed to the performance of C-sections and readily available in L&D. Drills and simulations are generally valuable, and expertise and support should always be available in the labor room to assist with donning and doffing of PPE.
 

Postpartum care

Expeditious separation of the COVID-19–positive mother from her infant is recommended, including avoidance of delayed cord clamping because of insufficient evidence of benefit to the infant. Insufficient evidence exists to support vertical transmission, but the possibility of maternal-infant transmission is clinically accepted based on small case reports of infection in a neonate at 30 hours of life and in infants of mothers with suspected or confirmed COVID-19.6,7 Accordingly, it is recommended that the benefit of early infant separation should be discussed with the mother. If approved, the infant should be kept in a separate isolation area and observed.

There is no evidence of breast milk transmission of the virus. For those electing to breastfeed, the patient should be provided with a breast pump to express and store the milk for subsequent bottle feeding. For mothers who elect to room in with the infant, a separation distance of 6 feet is recommended with an intervening barrier curtain. For COVID-19–positive mothers who elect breastfeeding, meticulous hand and face washing, continuous wearing of a mask, and cleansing of the breast prior to feeding needs to be maintained.

Restrictive visiting policies of no more than one visitor should be maintained. For severely or critically ill patients with COVID-19, it has been suggested that no visitors be allowed. As with other hospitalizations of COVID-19 patients, the HCW contact should be kept at a justifiable minimum to reduce the risk of transmission.
 

Protecting the obstetrician and other HCWs

Protecting the health of obstetricians and other HCWs is central to any successful strategy to fight the COVID-19 epidemic. For the individual obstetrician, careful attention to national and local hospital guidelines is required as these are rapidly evolving.

Physicians and their leadership must maintain an ongoing dialogue with hospital leadership to continually upgrade and optimize infection prevention and control measures, and to uphold best practices. The experience in Wuhan, China, illustrates the effectiveness of the proper use of PPE along with population control measures to reduce infections in HCWs. Prior to understanding the mechanism of virus transmission and using protective equipment, infection rates of 3%-29% were reported among HCWs. With the meticulous utilization of mitigation strategies and population control measures – including consistent use of PPE – the rate of infection of HCWs reportedly fell to zero.

In outpatient offices, all staff and HCWs should wear masks at all times and engage in social distancing and in frequent hand sanitization. Patients should be strongly encouraged to wear masks during office visits and on all other occasions when they will be in physical proximity to other individuals outside of the home.

Reports from epidemic areas describe transmission from household sources as a significant cause of HCW infection. The information emphasizes the need for ongoing vigilance and attention to sanitization measures even when at home with one’s family. An additional benefit is reduced risk of transmission from HCWs to family members.

Dr. Bahado-Singh is professor and chair of obstetrics and gynecology at Oakland University, Rochester, Mich., and health system chair for obstetrics and gynecology at Beaumont Health System.

References

1. Luo S et al. Clin Gastroenterol Hepatol. 2020 Mar 20. doi: 10.1016/j.cgh.2020.03.043.

2. Lechien JR et al. Eur Arch Otorhinolaryngol. 2020 Apr 6. doi: 10.1007/s00405-020-05965-1.

3. Breslin N et al. Am J Obstet Gynecol MFM. 2020 Apr 9. doi: 10.1016/j.ajogmf.2020.100118.

4. Zaigham M, Andersson O. Acta Obstet Gynecol Scand. 2020 Apr 7. doi: 10.1111/aogs.13867.

5. Di Mascio D et al. Am J Obstet Gynecol MFM. 2020 Mar 25. doi: 10.1016/j.ajogmf.2020.100107.

6. Ital J. Pediatr 2020;46(1) doi: 10.1186/s13052-020-0820-x. 

7. Int J Gynaecol Obstet. 2020;149(2):130-6. 

*This article was updated 5/6/2020.