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Axilla swelling after COVID booster puts focus on mammogram timing
This inflammation is caused by the enlargement of lymph nodes and can show up as an abnormal finding on mammograms and other types of chest scans, causing concern and even the need for additional imaging and follow up, wrote Constance D. Lehman, MD, PhD, and colleagues in an article published in Journal of the American College of Radiology.
Lymph node swelling is a normal immune system reaction to vaccination, and “COVID-19 vaccinations in the arm are a well-documented cause of inflammatory unilateral axillary adenopathy,” noted Dr. Lehman, in an interview. The side effect will occur on the side of the body where the patient received a vaccine, and it is not always noticeable to the woman experiencing it, she said.
“We’re finding that the patients’ bodies are responding to the booster in many ways that are similar to the initial COVID vaccines, with lymph node swelling, muscle aches and pains, headaches, and so on,” said Dr. Lehman, who is chief of breast imaging at the Massachusetts General Hospital, Boston. There have been no real differences in reactions between the Moderna and Pfizer vaccines, she added.
Because axillary lymph node swelling can obscure mammogram results, staff of at least a few imaging centers, including Penn State Breast Center in Hershey, Pa., and Providence Women’s Imaging Center in Torrance, Calif., told this news organization that they are asking women to delay mammogram imaging either 6 weeks or 4-6 weeks after getting a COVID-19 booster.
Experts’ suggestions on mammograms, boosters timing
Other experts, including Jessica Leung, MD, acknowledged that vaccine-related reactive adenopathy is seen after the booster dose and provided recommendations for the timing of getting mammograms and the booster with this in mind.
“I would recommend getting the screening mammogram first, which can be followed immediately by vaccination, even on the same day,” said Jessica Leung, MD, a professor of diagnostic radiology at the University of Texas MD Anderson Cancer Center in Houston, Tex.
“If this is not possible from the scheduling perspective, then the patient should consult her health care provider regarding whether it is okay to wait a bit after receiving the vaccine before getting her screening mammogram.”
The answer to that question will likely depend on the time interval since the prior mammogram and the patient’s personal risk factors for developing breast cancer. Dr. Leung noted. “This is all predicated on the assumption that the patient is asymptomatic. If she has any symptoms, for example a palpable breast lump, then she should seek medical attention regardless of timing of vaccination.”
The same holds true for boosters, she said.
She emphasized that careful consideration should be given before delaying the mammogram. “The medical community has a great deal more knowledge at this time than in the early days of COVID-19 vaccination, so we are often able to identify reactive adenopathy related to vaccination. If patients were to delay the mammogram, any reactive adenopathy may persist, on average, for 4-6 weeks.”
Debra Patt, MD, PhD, MBA, executive vice president at Texas Oncology, professor at the University of Texas at Austin, provided a specific example of when a patient should not delay the diagnostic imaging, which is “in the event that there is an abnormal mass in the breast that requires evaluation.”
Providers are now prepared to address these issues, she added.
Dr. Lehman’s nuanced recommendations
“It’s easy to get both a mammogram and booster, and just a matter of timing them – so that the reaction doesn’t interfere with the mammography results,” Dr. Lehman said.
But she emphasized that women should not be choosing between their mammograms or a booster. “We are now saying the same thing that we did with the initial vaccine,” said Dr. Lehman. “We don’t want patients delaying their mammograms, and we don’t want them delaying their boosters – both are critical to staying healthy.”
In her center, a model was developed to navigate vaccine-associated adenopathy. While this approach was developed for the primary vaccine series, the same applies for the booster, which is essentially a third dose of the same vaccine, explained Dr. Lehman.
When patients present for mammography, ultrasound, or MRI, the technologist will document their COVID-19 vaccination status (first or second dose or booster), the date it was given, and the location. Adding vaccination documentation to intake forms helps to support appropriate management of patients who undergo imaging after COVID-19 vaccination. Six weeks is used as the cutoff point for defining “recent” vaccination.
For patients who are getting a screening mammography or MRI, and who have no symptoms beyond unilateral axillary adenopathy on the same side of the body where they received the COVID-19 vaccination (given in the arm) within a 6-week period, the following is included in the screening mammography or screening MRI report: “In the specific setting of a patient with documented recent (within the past 6 weeks) COVID-19 vaccination in the ipsilateral arm, axillary adenopathy is a benign imaging finding. No further imaging is indicated at this time. If there is clinical concern that persists more than 6 weeks after the patient received the final vaccine dose, axillary ultrasound is recommended.”
The experts interviewed reported no conflicts of interest.
This inflammation is caused by the enlargement of lymph nodes and can show up as an abnormal finding on mammograms and other types of chest scans, causing concern and even the need for additional imaging and follow up, wrote Constance D. Lehman, MD, PhD, and colleagues in an article published in Journal of the American College of Radiology.
Lymph node swelling is a normal immune system reaction to vaccination, and “COVID-19 vaccinations in the arm are a well-documented cause of inflammatory unilateral axillary adenopathy,” noted Dr. Lehman, in an interview. The side effect will occur on the side of the body where the patient received a vaccine, and it is not always noticeable to the woman experiencing it, she said.
“We’re finding that the patients’ bodies are responding to the booster in many ways that are similar to the initial COVID vaccines, with lymph node swelling, muscle aches and pains, headaches, and so on,” said Dr. Lehman, who is chief of breast imaging at the Massachusetts General Hospital, Boston. There have been no real differences in reactions between the Moderna and Pfizer vaccines, she added.
Because axillary lymph node swelling can obscure mammogram results, staff of at least a few imaging centers, including Penn State Breast Center in Hershey, Pa., and Providence Women’s Imaging Center in Torrance, Calif., told this news organization that they are asking women to delay mammogram imaging either 6 weeks or 4-6 weeks after getting a COVID-19 booster.
Experts’ suggestions on mammograms, boosters timing
Other experts, including Jessica Leung, MD, acknowledged that vaccine-related reactive adenopathy is seen after the booster dose and provided recommendations for the timing of getting mammograms and the booster with this in mind.
“I would recommend getting the screening mammogram first, which can be followed immediately by vaccination, even on the same day,” said Jessica Leung, MD, a professor of diagnostic radiology at the University of Texas MD Anderson Cancer Center in Houston, Tex.
“If this is not possible from the scheduling perspective, then the patient should consult her health care provider regarding whether it is okay to wait a bit after receiving the vaccine before getting her screening mammogram.”
The answer to that question will likely depend on the time interval since the prior mammogram and the patient’s personal risk factors for developing breast cancer. Dr. Leung noted. “This is all predicated on the assumption that the patient is asymptomatic. If she has any symptoms, for example a palpable breast lump, then she should seek medical attention regardless of timing of vaccination.”
The same holds true for boosters, she said.
She emphasized that careful consideration should be given before delaying the mammogram. “The medical community has a great deal more knowledge at this time than in the early days of COVID-19 vaccination, so we are often able to identify reactive adenopathy related to vaccination. If patients were to delay the mammogram, any reactive adenopathy may persist, on average, for 4-6 weeks.”
Debra Patt, MD, PhD, MBA, executive vice president at Texas Oncology, professor at the University of Texas at Austin, provided a specific example of when a patient should not delay the diagnostic imaging, which is “in the event that there is an abnormal mass in the breast that requires evaluation.”
Providers are now prepared to address these issues, she added.
Dr. Lehman’s nuanced recommendations
“It’s easy to get both a mammogram and booster, and just a matter of timing them – so that the reaction doesn’t interfere with the mammography results,” Dr. Lehman said.
But she emphasized that women should not be choosing between their mammograms or a booster. “We are now saying the same thing that we did with the initial vaccine,” said Dr. Lehman. “We don’t want patients delaying their mammograms, and we don’t want them delaying their boosters – both are critical to staying healthy.”
In her center, a model was developed to navigate vaccine-associated adenopathy. While this approach was developed for the primary vaccine series, the same applies for the booster, which is essentially a third dose of the same vaccine, explained Dr. Lehman.
When patients present for mammography, ultrasound, or MRI, the technologist will document their COVID-19 vaccination status (first or second dose or booster), the date it was given, and the location. Adding vaccination documentation to intake forms helps to support appropriate management of patients who undergo imaging after COVID-19 vaccination. Six weeks is used as the cutoff point for defining “recent” vaccination.
For patients who are getting a screening mammography or MRI, and who have no symptoms beyond unilateral axillary adenopathy on the same side of the body where they received the COVID-19 vaccination (given in the arm) within a 6-week period, the following is included in the screening mammography or screening MRI report: “In the specific setting of a patient with documented recent (within the past 6 weeks) COVID-19 vaccination in the ipsilateral arm, axillary adenopathy is a benign imaging finding. No further imaging is indicated at this time. If there is clinical concern that persists more than 6 weeks after the patient received the final vaccine dose, axillary ultrasound is recommended.”
The experts interviewed reported no conflicts of interest.
This inflammation is caused by the enlargement of lymph nodes and can show up as an abnormal finding on mammograms and other types of chest scans, causing concern and even the need for additional imaging and follow up, wrote Constance D. Lehman, MD, PhD, and colleagues in an article published in Journal of the American College of Radiology.
Lymph node swelling is a normal immune system reaction to vaccination, and “COVID-19 vaccinations in the arm are a well-documented cause of inflammatory unilateral axillary adenopathy,” noted Dr. Lehman, in an interview. The side effect will occur on the side of the body where the patient received a vaccine, and it is not always noticeable to the woman experiencing it, she said.
“We’re finding that the patients’ bodies are responding to the booster in many ways that are similar to the initial COVID vaccines, with lymph node swelling, muscle aches and pains, headaches, and so on,” said Dr. Lehman, who is chief of breast imaging at the Massachusetts General Hospital, Boston. There have been no real differences in reactions between the Moderna and Pfizer vaccines, she added.
Because axillary lymph node swelling can obscure mammogram results, staff of at least a few imaging centers, including Penn State Breast Center in Hershey, Pa., and Providence Women’s Imaging Center in Torrance, Calif., told this news organization that they are asking women to delay mammogram imaging either 6 weeks or 4-6 weeks after getting a COVID-19 booster.
Experts’ suggestions on mammograms, boosters timing
Other experts, including Jessica Leung, MD, acknowledged that vaccine-related reactive adenopathy is seen after the booster dose and provided recommendations for the timing of getting mammograms and the booster with this in mind.
“I would recommend getting the screening mammogram first, which can be followed immediately by vaccination, even on the same day,” said Jessica Leung, MD, a professor of diagnostic radiology at the University of Texas MD Anderson Cancer Center in Houston, Tex.
“If this is not possible from the scheduling perspective, then the patient should consult her health care provider regarding whether it is okay to wait a bit after receiving the vaccine before getting her screening mammogram.”
The answer to that question will likely depend on the time interval since the prior mammogram and the patient’s personal risk factors for developing breast cancer. Dr. Leung noted. “This is all predicated on the assumption that the patient is asymptomatic. If she has any symptoms, for example a palpable breast lump, then she should seek medical attention regardless of timing of vaccination.”
The same holds true for boosters, she said.
She emphasized that careful consideration should be given before delaying the mammogram. “The medical community has a great deal more knowledge at this time than in the early days of COVID-19 vaccination, so we are often able to identify reactive adenopathy related to vaccination. If patients were to delay the mammogram, any reactive adenopathy may persist, on average, for 4-6 weeks.”
Debra Patt, MD, PhD, MBA, executive vice president at Texas Oncology, professor at the University of Texas at Austin, provided a specific example of when a patient should not delay the diagnostic imaging, which is “in the event that there is an abnormal mass in the breast that requires evaluation.”
Providers are now prepared to address these issues, she added.
Dr. Lehman’s nuanced recommendations
“It’s easy to get both a mammogram and booster, and just a matter of timing them – so that the reaction doesn’t interfere with the mammography results,” Dr. Lehman said.
But she emphasized that women should not be choosing between their mammograms or a booster. “We are now saying the same thing that we did with the initial vaccine,” said Dr. Lehman. “We don’t want patients delaying their mammograms, and we don’t want them delaying their boosters – both are critical to staying healthy.”
In her center, a model was developed to navigate vaccine-associated adenopathy. While this approach was developed for the primary vaccine series, the same applies for the booster, which is essentially a third dose of the same vaccine, explained Dr. Lehman.
When patients present for mammography, ultrasound, or MRI, the technologist will document their COVID-19 vaccination status (first or second dose or booster), the date it was given, and the location. Adding vaccination documentation to intake forms helps to support appropriate management of patients who undergo imaging after COVID-19 vaccination. Six weeks is used as the cutoff point for defining “recent” vaccination.
For patients who are getting a screening mammography or MRI, and who have no symptoms beyond unilateral axillary adenopathy on the same side of the body where they received the COVID-19 vaccination (given in the arm) within a 6-week period, the following is included in the screening mammography or screening MRI report: “In the specific setting of a patient with documented recent (within the past 6 weeks) COVID-19 vaccination in the ipsilateral arm, axillary adenopathy is a benign imaging finding. No further imaging is indicated at this time. If there is clinical concern that persists more than 6 weeks after the patient received the final vaccine dose, axillary ultrasound is recommended.”
The experts interviewed reported no conflicts of interest.
FDA agrees that mifepristone is safe enough to dispense by mail
The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.
In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.
As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”
That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
Decision comes amid Supreme Court debate
The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.
Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.
Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”
Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”
Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”
Others expressed doubt or outrage.
Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”
“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”
The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.
The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.
The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”
The modifications include:
- “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
- Adding a requirement that pharmacies must be certified to dispense the drug.
The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.
In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.
Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
Many states bar mailing of abortion pills
However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.
Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.
“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.
Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
Positive results when Canada lifted restrictions
As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.
A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.
Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”
Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.
The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”
The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.
In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.
As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”
That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
Decision comes amid Supreme Court debate
The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.
Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.
Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”
Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”
Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”
Others expressed doubt or outrage.
Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”
“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”
The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.
The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.
The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”
The modifications include:
- “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
- Adding a requirement that pharmacies must be certified to dispense the drug.
The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.
In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.
Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
Many states bar mailing of abortion pills
However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.
Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.
“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.
Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
Positive results when Canada lifted restrictions
As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.
A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.
Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”
Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.
The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”
The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.
In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.
As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”
That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
Decision comes amid Supreme Court debate
The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.
Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.
Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”
Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”
Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”
Others expressed doubt or outrage.
Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”
“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”
The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.
The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.
The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”
The modifications include:
- “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
- Adding a requirement that pharmacies must be certified to dispense the drug.
The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.
In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.
Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
Many states bar mailing of abortion pills
However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.
Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.
“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.
Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
Positive results when Canada lifted restrictions
As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.
A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.
Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”
Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.
The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”
Postmenopausal women with early breast cancer can go chemo-free
New results from the phase 3 RxPONDER trial add to mounting evidence that most postmenopausal women with early-stage breast cancer derive no added benefits from chemotherapy and can be effectively treated with endocrine therapy alone.
The study, published in The New England Journal of Medicine, conversely shows that premenopausal women do benefit from adjuvant chemotherapy, theorized by many to largely be the result of chemotherapy-induced ovarian function suppression.
The RxPONDER trial results are in line with those from the practice-changing TAILORx trial and underscore that “postmenopausal women with 1 to 3 positive nodes and [a recurrence score] of 0 to 25 can likely safely forgo adjuvant chemotherapy without compromising invasive disease-free survival,” first author Kevin Kalinsky, MD, of the Winship Cancer Institute at Emory University, Atlanta, told this news organization. “This will save tens of thousands of women the time, expense, and potentially harmful side effects that can be associated with chemotherapy infusions.”
However, the authors note, “premenopausal women with 1-3 positive lymph nodes had a significant benefit from chemotherapy.”
The study, conducted by the Southwest Oncology Group (SWOG) Cancer Research Network, involved 5,018 women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with one to three positive axillary lymph nodes – a breast cancer profile that represents approximately 20% of cases in the U.S.
All women had recurrence scores on the 100-point 21-gene breast cancer assay (Oncotype Dx) under 25, which is considered the lowest risk of recurrence. Patients were randomized to treatment with endocrine therapy only (n = 2,507) or chemotherapy followed by endocrine therapy (n = 2,511).
After a median follow-up of 5.3 years, women treated with adjunctive chemotherapy plus endocrine therapy exhibited no significant improvements in invasive disease-free survival compared to those who received endocrine therapy alone.
A prespecified analysis stratifying women by menopausal status underscored those results among postmenopausal women. In this cohort, researchers reported invasive disease-free survival was 91.9% in the endocrine-only group and 91.3% in the chemotherapy group (HR, 1.02; P = .89), indicating no benefit of the adjunctive chemotherapy.
However, among premenopausal women, the invasive disease-free survival rate was significantly higher with the addition of chemotherapy – 89.0% with endocrine-only therapy and 93.9% with both therapies (HR, 0.60; P = .002). Increases in distant relapse-free survival observed in the dual-therapy group similarly favored adding chemotherapy (HR, 0.58; P = .009).
Even when the authors further stratified the women into recurrence scores of 0 to 13 or 14 to 25, the results remained consistent. Postmenopausal women in each of the recurrence score groups continued to show no difference in invasive disease recurrence, new primary cancer, or death from chemotherapy (HR, 1.01 for each score group). Conversely, premenopausal women showed significant improvements in those outcomes when chemotherapy was added to endocrine therapy.
To what degree were the effects observed in premenopausal women the result of chemotherapy-induced ovarian suppression?
“I think it’s fair to say it’s the most interesting question right now in early-stage breast cancer for ER-positive tumors,” Harold Burstein, MD, of the Dana-Farber Cancer Institute and Harvard Medical School, Boston, said during a debate at the recent San Antonio Breast Cancer Symposium.
According to Sibylle Loibl, MD, PhD, when it comes to the use of chemotherapy, “age matters.”
“I strongly believe the biology of tumors is different in younger women with HR-positive/HER2-negative breast cancer,” Dr. Loibl, an associate professor at the University of Frankfurt, said during the debate. “It’s a different disease and the effects of chemotherapy are different.”
In young women, chemotherapy has “a direct cytotoxic effect, which cannot be neglected, and an endocrine effect on ovarian function suppression,” Dr. Loibl added. “I think both are needed in young premenopausal patients.”
According to the RxPONDER authors, “whether a chemotherapy benefit in premenopausal women is due to both direct cytocidal effects and treatment-induced menopause remains unclear,” but they noted that “it is possible that the contribution of these mechanisms may vary according to age.”
Further complicating matters, Dr. Loibl added, is that age appears to be poorly represented in genetic diagnostic tools.
“I think the gene expression profiles we are currently using as standard diagnostic tools do not capture the right biology for our premenopausal patients,” she said. “We have to keep in mind that these tests were designed and validated in postmenopausal patients and were only retrospectively used in premenopausal patients.”
The study was funded by the National Cancer Institute and others. Dr. Loibl has received honoraria from Prime and Chugai and numerous institutional research grants.
A version of this article first appeared on Medscape.com.
New results from the phase 3 RxPONDER trial add to mounting evidence that most postmenopausal women with early-stage breast cancer derive no added benefits from chemotherapy and can be effectively treated with endocrine therapy alone.
The study, published in The New England Journal of Medicine, conversely shows that premenopausal women do benefit from adjuvant chemotherapy, theorized by many to largely be the result of chemotherapy-induced ovarian function suppression.
The RxPONDER trial results are in line with those from the practice-changing TAILORx trial and underscore that “postmenopausal women with 1 to 3 positive nodes and [a recurrence score] of 0 to 25 can likely safely forgo adjuvant chemotherapy without compromising invasive disease-free survival,” first author Kevin Kalinsky, MD, of the Winship Cancer Institute at Emory University, Atlanta, told this news organization. “This will save tens of thousands of women the time, expense, and potentially harmful side effects that can be associated with chemotherapy infusions.”
However, the authors note, “premenopausal women with 1-3 positive lymph nodes had a significant benefit from chemotherapy.”
The study, conducted by the Southwest Oncology Group (SWOG) Cancer Research Network, involved 5,018 women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with one to three positive axillary lymph nodes – a breast cancer profile that represents approximately 20% of cases in the U.S.
All women had recurrence scores on the 100-point 21-gene breast cancer assay (Oncotype Dx) under 25, which is considered the lowest risk of recurrence. Patients were randomized to treatment with endocrine therapy only (n = 2,507) or chemotherapy followed by endocrine therapy (n = 2,511).
After a median follow-up of 5.3 years, women treated with adjunctive chemotherapy plus endocrine therapy exhibited no significant improvements in invasive disease-free survival compared to those who received endocrine therapy alone.
A prespecified analysis stratifying women by menopausal status underscored those results among postmenopausal women. In this cohort, researchers reported invasive disease-free survival was 91.9% in the endocrine-only group and 91.3% in the chemotherapy group (HR, 1.02; P = .89), indicating no benefit of the adjunctive chemotherapy.
However, among premenopausal women, the invasive disease-free survival rate was significantly higher with the addition of chemotherapy – 89.0% with endocrine-only therapy and 93.9% with both therapies (HR, 0.60; P = .002). Increases in distant relapse-free survival observed in the dual-therapy group similarly favored adding chemotherapy (HR, 0.58; P = .009).
Even when the authors further stratified the women into recurrence scores of 0 to 13 or 14 to 25, the results remained consistent. Postmenopausal women in each of the recurrence score groups continued to show no difference in invasive disease recurrence, new primary cancer, or death from chemotherapy (HR, 1.01 for each score group). Conversely, premenopausal women showed significant improvements in those outcomes when chemotherapy was added to endocrine therapy.
To what degree were the effects observed in premenopausal women the result of chemotherapy-induced ovarian suppression?
“I think it’s fair to say it’s the most interesting question right now in early-stage breast cancer for ER-positive tumors,” Harold Burstein, MD, of the Dana-Farber Cancer Institute and Harvard Medical School, Boston, said during a debate at the recent San Antonio Breast Cancer Symposium.
According to Sibylle Loibl, MD, PhD, when it comes to the use of chemotherapy, “age matters.”
“I strongly believe the biology of tumors is different in younger women with HR-positive/HER2-negative breast cancer,” Dr. Loibl, an associate professor at the University of Frankfurt, said during the debate. “It’s a different disease and the effects of chemotherapy are different.”
In young women, chemotherapy has “a direct cytotoxic effect, which cannot be neglected, and an endocrine effect on ovarian function suppression,” Dr. Loibl added. “I think both are needed in young premenopausal patients.”
According to the RxPONDER authors, “whether a chemotherapy benefit in premenopausal women is due to both direct cytocidal effects and treatment-induced menopause remains unclear,” but they noted that “it is possible that the contribution of these mechanisms may vary according to age.”
Further complicating matters, Dr. Loibl added, is that age appears to be poorly represented in genetic diagnostic tools.
“I think the gene expression profiles we are currently using as standard diagnostic tools do not capture the right biology for our premenopausal patients,” she said. “We have to keep in mind that these tests were designed and validated in postmenopausal patients and were only retrospectively used in premenopausal patients.”
The study was funded by the National Cancer Institute and others. Dr. Loibl has received honoraria from Prime and Chugai and numerous institutional research grants.
A version of this article first appeared on Medscape.com.
New results from the phase 3 RxPONDER trial add to mounting evidence that most postmenopausal women with early-stage breast cancer derive no added benefits from chemotherapy and can be effectively treated with endocrine therapy alone.
The study, published in The New England Journal of Medicine, conversely shows that premenopausal women do benefit from adjuvant chemotherapy, theorized by many to largely be the result of chemotherapy-induced ovarian function suppression.
The RxPONDER trial results are in line with those from the practice-changing TAILORx trial and underscore that “postmenopausal women with 1 to 3 positive nodes and [a recurrence score] of 0 to 25 can likely safely forgo adjuvant chemotherapy without compromising invasive disease-free survival,” first author Kevin Kalinsky, MD, of the Winship Cancer Institute at Emory University, Atlanta, told this news organization. “This will save tens of thousands of women the time, expense, and potentially harmful side effects that can be associated with chemotherapy infusions.”
However, the authors note, “premenopausal women with 1-3 positive lymph nodes had a significant benefit from chemotherapy.”
The study, conducted by the Southwest Oncology Group (SWOG) Cancer Research Network, involved 5,018 women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with one to three positive axillary lymph nodes – a breast cancer profile that represents approximately 20% of cases in the U.S.
All women had recurrence scores on the 100-point 21-gene breast cancer assay (Oncotype Dx) under 25, which is considered the lowest risk of recurrence. Patients were randomized to treatment with endocrine therapy only (n = 2,507) or chemotherapy followed by endocrine therapy (n = 2,511).
After a median follow-up of 5.3 years, women treated with adjunctive chemotherapy plus endocrine therapy exhibited no significant improvements in invasive disease-free survival compared to those who received endocrine therapy alone.
A prespecified analysis stratifying women by menopausal status underscored those results among postmenopausal women. In this cohort, researchers reported invasive disease-free survival was 91.9% in the endocrine-only group and 91.3% in the chemotherapy group (HR, 1.02; P = .89), indicating no benefit of the adjunctive chemotherapy.
However, among premenopausal women, the invasive disease-free survival rate was significantly higher with the addition of chemotherapy – 89.0% with endocrine-only therapy and 93.9% with both therapies (HR, 0.60; P = .002). Increases in distant relapse-free survival observed in the dual-therapy group similarly favored adding chemotherapy (HR, 0.58; P = .009).
Even when the authors further stratified the women into recurrence scores of 0 to 13 or 14 to 25, the results remained consistent. Postmenopausal women in each of the recurrence score groups continued to show no difference in invasive disease recurrence, new primary cancer, or death from chemotherapy (HR, 1.01 for each score group). Conversely, premenopausal women showed significant improvements in those outcomes when chemotherapy was added to endocrine therapy.
To what degree were the effects observed in premenopausal women the result of chemotherapy-induced ovarian suppression?
“I think it’s fair to say it’s the most interesting question right now in early-stage breast cancer for ER-positive tumors,” Harold Burstein, MD, of the Dana-Farber Cancer Institute and Harvard Medical School, Boston, said during a debate at the recent San Antonio Breast Cancer Symposium.
According to Sibylle Loibl, MD, PhD, when it comes to the use of chemotherapy, “age matters.”
“I strongly believe the biology of tumors is different in younger women with HR-positive/HER2-negative breast cancer,” Dr. Loibl, an associate professor at the University of Frankfurt, said during the debate. “It’s a different disease and the effects of chemotherapy are different.”
In young women, chemotherapy has “a direct cytotoxic effect, which cannot be neglected, and an endocrine effect on ovarian function suppression,” Dr. Loibl added. “I think both are needed in young premenopausal patients.”
According to the RxPONDER authors, “whether a chemotherapy benefit in premenopausal women is due to both direct cytocidal effects and treatment-induced menopause remains unclear,” but they noted that “it is possible that the contribution of these mechanisms may vary according to age.”
Further complicating matters, Dr. Loibl added, is that age appears to be poorly represented in genetic diagnostic tools.
“I think the gene expression profiles we are currently using as standard diagnostic tools do not capture the right biology for our premenopausal patients,” she said. “We have to keep in mind that these tests were designed and validated in postmenopausal patients and were only retrospectively used in premenopausal patients.”
The study was funded by the National Cancer Institute and others. Dr. Loibl has received honoraria from Prime and Chugai and numerous institutional research grants.
A version of this article first appeared on Medscape.com.
Study finds more adverse maternal outcomes in women with disabilities
Women with physical, intellectual, and sensory disabilities had higher risk for almost all pregnancy complications, obstetric interventions, and adverse outcomes, including severe maternal morbidity (SMM) and mortality compared to women without disabilities, according to an analysis of a large, retrospective cohort.
The findings, published in JAMA Network Open (2021;4[12]:e2138414 doi: 10.1001/jamanetworkopen.2021.38414), “may be a direct reflection of the challenges women with all types of disabilities face when accessing and receiving care, which is likely compounded by poorer preconception health,” suggested lead author Jessica L. Gleason, PhD, MPH, and co-authors, all from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.
“Women with disabilities have long been ignored in obstetric research and clinical practice,” added Hilary K. Brown, PhD, from the University of Toronto, in an accompanying editorial. “Inclusion of disability indicators needs to be the norm – not the exception – in health administrative data so that these disparities can be regularly tracked and addressed.”
The investigators used data from the Consortium on Safe Labor (CSL), a retrospective cohort of deliveries from 12 U.S. clinical centers between Jan. 2002 and Jan. 2008, to analyze obstetric interventions and adverse maternal outcomes in women with and without disabilities.
The analysis included a total of 223,385 women, mean age 27.6 years, of whom 2,074 (0.9%) had a disability, and 221,311 did not. Among those with disabilities, 1,733 (83.5%) were physical, 91 (4.4%) were intellectual, and 250 (12.1%) were sensory. While almost half (49.4%) of the women were White, 22.5% were Black, 17.5% were Hispanic, and 4.1% were Asian or Pacific Islander.
Outcomes were analyzed with three composite measures:
- Pregnancy-related complications (pregnancy-related hypertensive diseases, gestational diabetes, placental abruption, placenta previa, premature rupture of membranes, preterm PROM);
- All labor, delivery, and postpartum complications (chorioamnionitis, hemorrhage, blood transfusion, thromboembolism, postpartum fever, infection, cardiovascular events, cardiomyopathy, and maternal death);
- SMM only, including severe pre-eclampsia/eclampsia, hemorrhage, thromboembolism, fever, infection, cardiomyopathy, and cardiovascular events during labor and delivery.
After adjustment for covariates, women with disabilities had higher risk of pregnancy-related complications. This included a 48% higher risk of mild pre-eclampsia and double the risk of severe pre-eclampsia/eclampsia. The composite risk of any pregnancy complication was 27% higher for women with physical disabilities, 49% higher for women with intellectual disabilities, and 53% higher for women with sensory disabilities.
The findings were similar for labor, delivery, and postpartum complications, showing women with disabilities had higher risk for a range of obstetrical interventions, including cesarean delivery – both planned and intrapartum (aRR, 1.34). Additionally, women with disabilities were less likely to have a cesarean delivery that was “solely clinically indicated” (aRR, 0.79), and more likely to have a cesarean delivery for “softer” mixed indication (aRR, 1.16), “supporting a possible overuse of cesarean delivery among women with disability,” they suggested.
Women with disabilities also had a higher risk of postpartum hemorrhage (aRR, 1.27), blood transfusion (aRR, 1.64), and maternal mortality (aRR, 11.19), as well as individual markers of severe maternal morbidity, such as cardiovascular events (aRR, 4.02), infection (aRR, 2.69), and venous thromboembolism (aRR, 6.08).
The authors speculate that the increased risks for women with disabilities “may be the result of a combination of independent risk factors, including the higher rate of obstetric intervention via cesarean delivery, under-recognition of women with disabilities as a population with higher-risk pregnancies, and lack of health care practitioner knowledge or comfort in managing pregnancies among women with disabilities.”
Dr. Brown noted in her commentary that there is a need for better education of health care professionals in this area. “Given that 12% of reproductive-aged women have a disability, that pregnancy rates are similar among women with and without disabilities, and that women with disabilities are at elevated risk of a range of adverse maternal outcomes, including severe maternal morbidity and maternal mortality, disability modules should be a mandatory component of education for obstetricians and midwives as well as other obstetrical health care professionals.”
Calling the study “a serious wake-up call,” Monika Mitra, PhD, told this publication that the findings highlight the need for “urgent attention” on improving obstetric care for people with disabilities “with a focus on accessibility and inclusion, changing clinical practice to better serve disabled people, integrating disability-related training for health care practitioners, and developing evidence-based interventions to support people with disabilities during this time.” The associate professor and director of the Lurie Institute for Disability Policy, in Brandeis University, Waltham, Mass. said the risk factors for poor outcomes are present early in pregnancy or even preconception. “We know that disabled women report barriers in accessing health care and receive lower-quality care compared to nondisabled women and are more likely to experience poverty, housing and food insecurity, educational and employment barriers, abuse, chronic health conditions, and mental illness than women without disabilities.”
She noted that the study’s sample of people with disabilities was small, and the measure of disability used was based on ICD-9 codes, which captures only severe disabilities. “As noted in the commentary by [Dr.] Brown, our standard sources of health administrative data do not give us the full picture on disability, and we need other, more equitable ways of identifying disability based, for example, on self-reports of activity or participation limitations if we are to be able to understand the effects on obstetric outcomes of health and health care disparities and of social determinants of health. Moreover, researchers have generally not yet begun to incorporate knowledge of the experiences of transgender people during pregnancy, which will impact our measures and study of obstetric outcomes among people with disabilities as well as the language we use.”
The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study authors and Dr. Brown reported no conflicts of interest. Dr. Mitra receives funding from the NICHD and the National Institute on Disability, Independent Living for research on pregnancy outcomes among people with disabilities.
obnews@mdedge.com
Women with physical, intellectual, and sensory disabilities had higher risk for almost all pregnancy complications, obstetric interventions, and adverse outcomes, including severe maternal morbidity (SMM) and mortality compared to women without disabilities, according to an analysis of a large, retrospective cohort.
The findings, published in JAMA Network Open (2021;4[12]:e2138414 doi: 10.1001/jamanetworkopen.2021.38414), “may be a direct reflection of the challenges women with all types of disabilities face when accessing and receiving care, which is likely compounded by poorer preconception health,” suggested lead author Jessica L. Gleason, PhD, MPH, and co-authors, all from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.
“Women with disabilities have long been ignored in obstetric research and clinical practice,” added Hilary K. Brown, PhD, from the University of Toronto, in an accompanying editorial. “Inclusion of disability indicators needs to be the norm – not the exception – in health administrative data so that these disparities can be regularly tracked and addressed.”
The investigators used data from the Consortium on Safe Labor (CSL), a retrospective cohort of deliveries from 12 U.S. clinical centers between Jan. 2002 and Jan. 2008, to analyze obstetric interventions and adverse maternal outcomes in women with and without disabilities.
The analysis included a total of 223,385 women, mean age 27.6 years, of whom 2,074 (0.9%) had a disability, and 221,311 did not. Among those with disabilities, 1,733 (83.5%) were physical, 91 (4.4%) were intellectual, and 250 (12.1%) were sensory. While almost half (49.4%) of the women were White, 22.5% were Black, 17.5% were Hispanic, and 4.1% were Asian or Pacific Islander.
Outcomes were analyzed with three composite measures:
- Pregnancy-related complications (pregnancy-related hypertensive diseases, gestational diabetes, placental abruption, placenta previa, premature rupture of membranes, preterm PROM);
- All labor, delivery, and postpartum complications (chorioamnionitis, hemorrhage, blood transfusion, thromboembolism, postpartum fever, infection, cardiovascular events, cardiomyopathy, and maternal death);
- SMM only, including severe pre-eclampsia/eclampsia, hemorrhage, thromboembolism, fever, infection, cardiomyopathy, and cardiovascular events during labor and delivery.
After adjustment for covariates, women with disabilities had higher risk of pregnancy-related complications. This included a 48% higher risk of mild pre-eclampsia and double the risk of severe pre-eclampsia/eclampsia. The composite risk of any pregnancy complication was 27% higher for women with physical disabilities, 49% higher for women with intellectual disabilities, and 53% higher for women with sensory disabilities.
The findings were similar for labor, delivery, and postpartum complications, showing women with disabilities had higher risk for a range of obstetrical interventions, including cesarean delivery – both planned and intrapartum (aRR, 1.34). Additionally, women with disabilities were less likely to have a cesarean delivery that was “solely clinically indicated” (aRR, 0.79), and more likely to have a cesarean delivery for “softer” mixed indication (aRR, 1.16), “supporting a possible overuse of cesarean delivery among women with disability,” they suggested.
Women with disabilities also had a higher risk of postpartum hemorrhage (aRR, 1.27), blood transfusion (aRR, 1.64), and maternal mortality (aRR, 11.19), as well as individual markers of severe maternal morbidity, such as cardiovascular events (aRR, 4.02), infection (aRR, 2.69), and venous thromboembolism (aRR, 6.08).
The authors speculate that the increased risks for women with disabilities “may be the result of a combination of independent risk factors, including the higher rate of obstetric intervention via cesarean delivery, under-recognition of women with disabilities as a population with higher-risk pregnancies, and lack of health care practitioner knowledge or comfort in managing pregnancies among women with disabilities.”
Dr. Brown noted in her commentary that there is a need for better education of health care professionals in this area. “Given that 12% of reproductive-aged women have a disability, that pregnancy rates are similar among women with and without disabilities, and that women with disabilities are at elevated risk of a range of adverse maternal outcomes, including severe maternal morbidity and maternal mortality, disability modules should be a mandatory component of education for obstetricians and midwives as well as other obstetrical health care professionals.”
Calling the study “a serious wake-up call,” Monika Mitra, PhD, told this publication that the findings highlight the need for “urgent attention” on improving obstetric care for people with disabilities “with a focus on accessibility and inclusion, changing clinical practice to better serve disabled people, integrating disability-related training for health care practitioners, and developing evidence-based interventions to support people with disabilities during this time.” The associate professor and director of the Lurie Institute for Disability Policy, in Brandeis University, Waltham, Mass. said the risk factors for poor outcomes are present early in pregnancy or even preconception. “We know that disabled women report barriers in accessing health care and receive lower-quality care compared to nondisabled women and are more likely to experience poverty, housing and food insecurity, educational and employment barriers, abuse, chronic health conditions, and mental illness than women without disabilities.”
She noted that the study’s sample of people with disabilities was small, and the measure of disability used was based on ICD-9 codes, which captures only severe disabilities. “As noted in the commentary by [Dr.] Brown, our standard sources of health administrative data do not give us the full picture on disability, and we need other, more equitable ways of identifying disability based, for example, on self-reports of activity or participation limitations if we are to be able to understand the effects on obstetric outcomes of health and health care disparities and of social determinants of health. Moreover, researchers have generally not yet begun to incorporate knowledge of the experiences of transgender people during pregnancy, which will impact our measures and study of obstetric outcomes among people with disabilities as well as the language we use.”
The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study authors and Dr. Brown reported no conflicts of interest. Dr. Mitra receives funding from the NICHD and the National Institute on Disability, Independent Living for research on pregnancy outcomes among people with disabilities.
obnews@mdedge.com
Women with physical, intellectual, and sensory disabilities had higher risk for almost all pregnancy complications, obstetric interventions, and adverse outcomes, including severe maternal morbidity (SMM) and mortality compared to women without disabilities, according to an analysis of a large, retrospective cohort.
The findings, published in JAMA Network Open (2021;4[12]:e2138414 doi: 10.1001/jamanetworkopen.2021.38414), “may be a direct reflection of the challenges women with all types of disabilities face when accessing and receiving care, which is likely compounded by poorer preconception health,” suggested lead author Jessica L. Gleason, PhD, MPH, and co-authors, all from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.
“Women with disabilities have long been ignored in obstetric research and clinical practice,” added Hilary K. Brown, PhD, from the University of Toronto, in an accompanying editorial. “Inclusion of disability indicators needs to be the norm – not the exception – in health administrative data so that these disparities can be regularly tracked and addressed.”
The investigators used data from the Consortium on Safe Labor (CSL), a retrospective cohort of deliveries from 12 U.S. clinical centers between Jan. 2002 and Jan. 2008, to analyze obstetric interventions and adverse maternal outcomes in women with and without disabilities.
The analysis included a total of 223,385 women, mean age 27.6 years, of whom 2,074 (0.9%) had a disability, and 221,311 did not. Among those with disabilities, 1,733 (83.5%) were physical, 91 (4.4%) were intellectual, and 250 (12.1%) were sensory. While almost half (49.4%) of the women were White, 22.5% were Black, 17.5% were Hispanic, and 4.1% were Asian or Pacific Islander.
Outcomes were analyzed with three composite measures:
- Pregnancy-related complications (pregnancy-related hypertensive diseases, gestational diabetes, placental abruption, placenta previa, premature rupture of membranes, preterm PROM);
- All labor, delivery, and postpartum complications (chorioamnionitis, hemorrhage, blood transfusion, thromboembolism, postpartum fever, infection, cardiovascular events, cardiomyopathy, and maternal death);
- SMM only, including severe pre-eclampsia/eclampsia, hemorrhage, thromboembolism, fever, infection, cardiomyopathy, and cardiovascular events during labor and delivery.
After adjustment for covariates, women with disabilities had higher risk of pregnancy-related complications. This included a 48% higher risk of mild pre-eclampsia and double the risk of severe pre-eclampsia/eclampsia. The composite risk of any pregnancy complication was 27% higher for women with physical disabilities, 49% higher for women with intellectual disabilities, and 53% higher for women with sensory disabilities.
The findings were similar for labor, delivery, and postpartum complications, showing women with disabilities had higher risk for a range of obstetrical interventions, including cesarean delivery – both planned and intrapartum (aRR, 1.34). Additionally, women with disabilities were less likely to have a cesarean delivery that was “solely clinically indicated” (aRR, 0.79), and more likely to have a cesarean delivery for “softer” mixed indication (aRR, 1.16), “supporting a possible overuse of cesarean delivery among women with disability,” they suggested.
Women with disabilities also had a higher risk of postpartum hemorrhage (aRR, 1.27), blood transfusion (aRR, 1.64), and maternal mortality (aRR, 11.19), as well as individual markers of severe maternal morbidity, such as cardiovascular events (aRR, 4.02), infection (aRR, 2.69), and venous thromboembolism (aRR, 6.08).
The authors speculate that the increased risks for women with disabilities “may be the result of a combination of independent risk factors, including the higher rate of obstetric intervention via cesarean delivery, under-recognition of women with disabilities as a population with higher-risk pregnancies, and lack of health care practitioner knowledge or comfort in managing pregnancies among women with disabilities.”
Dr. Brown noted in her commentary that there is a need for better education of health care professionals in this area. “Given that 12% of reproductive-aged women have a disability, that pregnancy rates are similar among women with and without disabilities, and that women with disabilities are at elevated risk of a range of adverse maternal outcomes, including severe maternal morbidity and maternal mortality, disability modules should be a mandatory component of education for obstetricians and midwives as well as other obstetrical health care professionals.”
Calling the study “a serious wake-up call,” Monika Mitra, PhD, told this publication that the findings highlight the need for “urgent attention” on improving obstetric care for people with disabilities “with a focus on accessibility and inclusion, changing clinical practice to better serve disabled people, integrating disability-related training for health care practitioners, and developing evidence-based interventions to support people with disabilities during this time.” The associate professor and director of the Lurie Institute for Disability Policy, in Brandeis University, Waltham, Mass. said the risk factors for poor outcomes are present early in pregnancy or even preconception. “We know that disabled women report barriers in accessing health care and receive lower-quality care compared to nondisabled women and are more likely to experience poverty, housing and food insecurity, educational and employment barriers, abuse, chronic health conditions, and mental illness than women without disabilities.”
She noted that the study’s sample of people with disabilities was small, and the measure of disability used was based on ICD-9 codes, which captures only severe disabilities. “As noted in the commentary by [Dr.] Brown, our standard sources of health administrative data do not give us the full picture on disability, and we need other, more equitable ways of identifying disability based, for example, on self-reports of activity or participation limitations if we are to be able to understand the effects on obstetric outcomes of health and health care disparities and of social determinants of health. Moreover, researchers have generally not yet begun to incorporate knowledge of the experiences of transgender people during pregnancy, which will impact our measures and study of obstetric outcomes among people with disabilities as well as the language we use.”
The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study authors and Dr. Brown reported no conflicts of interest. Dr. Mitra receives funding from the NICHD and the National Institute on Disability, Independent Living for research on pregnancy outcomes among people with disabilities.
obnews@mdedge.com
Delayed umbilical cord clamping improves outcomes in very preterm infants
Delayed umbilical cord clamping for at least 60 seconds after birth significantly reduced death or disability in infants of less than 30 weeks’ gestation, according to data from nearly 1,500 infants.
The burden of disability and mortality for babies born before 30 weeks’ gestation remains high, especially in low- and middle-income countries, wrote Kristy P. Robledo, PhD, of the University of Sydney, Australia, and colleagues. Delayed clamping of the umbilical cord is a simple procedure that may improve mortality in this population, but more research is needed; recommended times to delayed clamping range from 30 seconds to 3 minutes, they noted.
In a study published in The Lancet Child & Adolescent Health, the researchers randomized 767 very preterm infants to delayed clamping at least 60 seconds after birth and 764 to immediate clamping. Of these, 384 were multiple births (who were individually randomized), 862 were male, and 505 were born before 27 weeks’ gestation. The primary outcome was death or disability at 2 years of age. Major disability was defined as cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay at 2 years corrected age. The median time to clamping was 60 seconds in the delayed group and 5 seconds in the immediate group.
Primary outcome data were available for 1,419 infants. Death or major disability occurred in 29% of infants assigned to delayed clamping compared to 34% of those assigned to immediate clamping (relative risk 0.83, P = .010). The infants were part of the APTS Childhood Follow-Up Study, an open-label superiority trial conducted in Australia and New Zealand.
By age 2 years, 8% of infants in the delayed group and 11% of those in the immediate group had died; 23% and 26%, respectively, met criteria for major disability. The impact of delayed clamping translates to a 30% reduction in relative risk of mortality at 2 years of age, but no significant impact on major disability, the researchers wrote.
The findings were limited by several factors including the unblinded study design, lack of data on heart rate or time to first breath, and the clamping prior to 60 seconds in 26% of infants in the delayed group based on clinical concerns for these specific infants, the researchers noted.
However, the results were strengthened by the large size, low risk of bias, and specific primary outcome, they said. The data support findings from recent systematic reviews and highlight the need for further trials to evaluate delayed clamping at different time points, with larger populations, inclusion of time to first breath and heart rate, and improved measures of disability, the researchers added.
In clinical practice, “Given that aiming to delay cord clamping for 60 seconds or more improved 2-year outcomes and short-term hematological measures with no evidence of significant harm, it seems reasonable to conclude that delayed clamping is appropriate as standard care in very preterm infants,” they concluded.
Accepting simple intervention could have great impact
This study is important in light of the overwhelming burden of preterm birth on the health care system and society as a whole, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview.
“Preterm birth is associated with billions in health care costs each year, and a large portion of that money is directed to the complications associated with preterm birth, such as early intervention services, educational support, and ongoing medical care,” Dr. Tanner said. “This study is particularly timely, as we are quickly approaching 2030, the deadline for achieving the United Nations Sustainable Development Goal of ending preventable deaths of newborns and children under 5 years of age,” she said. The goal involves “all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births. Effective treatments to reduce infant and child mortality would make strong inroads toward this goal,” she explained.
Dr. Tanner said she was not surprised by the findings because previous studies have shown similar results. “However, the large, multicenter nature of this study provides additional weight to recommendations to delay cord clamping as standard practice,” she said.
“The findings of this study support the recommendations of a number of large organizations,” said Dr. Tanner. “The World Health Organization recommends that the umbilical cord not be clamped earlier than 1 minute after birth in term or preterm infants who do not require positive pressure ventilation. The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics now recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at least 30–60 seconds after birth,” she said. “The Royal College of Obstetricians and Gynaecologists also recommends deferring umbilical cord clamping for healthy term and preterm infants for at least 2 minutes after birth,” she added.
However, “the delay in adoption of this guidelines in practice appears to be related to some concerns regarding universal adoption of this approach,” Dr. Tanner noted. “Some clinicians have suggested that delayed cord clamping could delay vital neonatal resuscitative efforts, leading to worse neonatal outcomes, but this concern has not been borne out in the data, as all guidelines specifically state that this intervention is for vigorous newborns,” she said. “In fact, in preterm infants, delayed cord clamping is associated with improved transitional circulation, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage,” Dr. Tanner emphasized. “Additionally, concerns persist that delayed cord clamping could lead to excessive transfusion with resultant polycythemia. Again, no data have supported this claim to date,” she said.
“Finally, some clinicians are concerned that delayed clamping could lead to delay in addressing maternal complications of birth such as hemorrhage, but studies have shown the opposite; delayed umbilical cord clamping has not been associated with an increased risk of postpartum hemorrhage or increased blood loss at delivery, nor has it been with a difference in the need for blood transfusion,” said Dr. Tanner.
Ideally, practitioners will become more comfortable in delaying cord clamping as a routine practice as more data demonstrating the safety and benefit of this easy intervention are disseminated, she said.
Additional research delineating which gestational ages benefit most from delayed cord clamping would help direct education efforts to implement this intervention, Dr. Tanner noted.
The study was funded by the Australian National Health and Medical Research Council. The researchers and Dr. Tanner had no financial conflicts to disclose.
Delayed umbilical cord clamping for at least 60 seconds after birth significantly reduced death or disability in infants of less than 30 weeks’ gestation, according to data from nearly 1,500 infants.
The burden of disability and mortality for babies born before 30 weeks’ gestation remains high, especially in low- and middle-income countries, wrote Kristy P. Robledo, PhD, of the University of Sydney, Australia, and colleagues. Delayed clamping of the umbilical cord is a simple procedure that may improve mortality in this population, but more research is needed; recommended times to delayed clamping range from 30 seconds to 3 minutes, they noted.
In a study published in The Lancet Child & Adolescent Health, the researchers randomized 767 very preterm infants to delayed clamping at least 60 seconds after birth and 764 to immediate clamping. Of these, 384 were multiple births (who were individually randomized), 862 were male, and 505 were born before 27 weeks’ gestation. The primary outcome was death or disability at 2 years of age. Major disability was defined as cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay at 2 years corrected age. The median time to clamping was 60 seconds in the delayed group and 5 seconds in the immediate group.
Primary outcome data were available for 1,419 infants. Death or major disability occurred in 29% of infants assigned to delayed clamping compared to 34% of those assigned to immediate clamping (relative risk 0.83, P = .010). The infants were part of the APTS Childhood Follow-Up Study, an open-label superiority trial conducted in Australia and New Zealand.
By age 2 years, 8% of infants in the delayed group and 11% of those in the immediate group had died; 23% and 26%, respectively, met criteria for major disability. The impact of delayed clamping translates to a 30% reduction in relative risk of mortality at 2 years of age, but no significant impact on major disability, the researchers wrote.
The findings were limited by several factors including the unblinded study design, lack of data on heart rate or time to first breath, and the clamping prior to 60 seconds in 26% of infants in the delayed group based on clinical concerns for these specific infants, the researchers noted.
However, the results were strengthened by the large size, low risk of bias, and specific primary outcome, they said. The data support findings from recent systematic reviews and highlight the need for further trials to evaluate delayed clamping at different time points, with larger populations, inclusion of time to first breath and heart rate, and improved measures of disability, the researchers added.
In clinical practice, “Given that aiming to delay cord clamping for 60 seconds or more improved 2-year outcomes and short-term hematological measures with no evidence of significant harm, it seems reasonable to conclude that delayed clamping is appropriate as standard care in very preterm infants,” they concluded.
Accepting simple intervention could have great impact
This study is important in light of the overwhelming burden of preterm birth on the health care system and society as a whole, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview.
“Preterm birth is associated with billions in health care costs each year, and a large portion of that money is directed to the complications associated with preterm birth, such as early intervention services, educational support, and ongoing medical care,” Dr. Tanner said. “This study is particularly timely, as we are quickly approaching 2030, the deadline for achieving the United Nations Sustainable Development Goal of ending preventable deaths of newborns and children under 5 years of age,” she said. The goal involves “all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births. Effective treatments to reduce infant and child mortality would make strong inroads toward this goal,” she explained.
Dr. Tanner said she was not surprised by the findings because previous studies have shown similar results. “However, the large, multicenter nature of this study provides additional weight to recommendations to delay cord clamping as standard practice,” she said.
“The findings of this study support the recommendations of a number of large organizations,” said Dr. Tanner. “The World Health Organization recommends that the umbilical cord not be clamped earlier than 1 minute after birth in term or preterm infants who do not require positive pressure ventilation. The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics now recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at least 30–60 seconds after birth,” she said. “The Royal College of Obstetricians and Gynaecologists also recommends deferring umbilical cord clamping for healthy term and preterm infants for at least 2 minutes after birth,” she added.
However, “the delay in adoption of this guidelines in practice appears to be related to some concerns regarding universal adoption of this approach,” Dr. Tanner noted. “Some clinicians have suggested that delayed cord clamping could delay vital neonatal resuscitative efforts, leading to worse neonatal outcomes, but this concern has not been borne out in the data, as all guidelines specifically state that this intervention is for vigorous newborns,” she said. “In fact, in preterm infants, delayed cord clamping is associated with improved transitional circulation, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage,” Dr. Tanner emphasized. “Additionally, concerns persist that delayed cord clamping could lead to excessive transfusion with resultant polycythemia. Again, no data have supported this claim to date,” she said.
“Finally, some clinicians are concerned that delayed clamping could lead to delay in addressing maternal complications of birth such as hemorrhage, but studies have shown the opposite; delayed umbilical cord clamping has not been associated with an increased risk of postpartum hemorrhage or increased blood loss at delivery, nor has it been with a difference in the need for blood transfusion,” said Dr. Tanner.
Ideally, practitioners will become more comfortable in delaying cord clamping as a routine practice as more data demonstrating the safety and benefit of this easy intervention are disseminated, she said.
Additional research delineating which gestational ages benefit most from delayed cord clamping would help direct education efforts to implement this intervention, Dr. Tanner noted.
The study was funded by the Australian National Health and Medical Research Council. The researchers and Dr. Tanner had no financial conflicts to disclose.
Delayed umbilical cord clamping for at least 60 seconds after birth significantly reduced death or disability in infants of less than 30 weeks’ gestation, according to data from nearly 1,500 infants.
The burden of disability and mortality for babies born before 30 weeks’ gestation remains high, especially in low- and middle-income countries, wrote Kristy P. Robledo, PhD, of the University of Sydney, Australia, and colleagues. Delayed clamping of the umbilical cord is a simple procedure that may improve mortality in this population, but more research is needed; recommended times to delayed clamping range from 30 seconds to 3 minutes, they noted.
In a study published in The Lancet Child & Adolescent Health, the researchers randomized 767 very preterm infants to delayed clamping at least 60 seconds after birth and 764 to immediate clamping. Of these, 384 were multiple births (who were individually randomized), 862 were male, and 505 were born before 27 weeks’ gestation. The primary outcome was death or disability at 2 years of age. Major disability was defined as cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay at 2 years corrected age. The median time to clamping was 60 seconds in the delayed group and 5 seconds in the immediate group.
Primary outcome data were available for 1,419 infants. Death or major disability occurred in 29% of infants assigned to delayed clamping compared to 34% of those assigned to immediate clamping (relative risk 0.83, P = .010). The infants were part of the APTS Childhood Follow-Up Study, an open-label superiority trial conducted in Australia and New Zealand.
By age 2 years, 8% of infants in the delayed group and 11% of those in the immediate group had died; 23% and 26%, respectively, met criteria for major disability. The impact of delayed clamping translates to a 30% reduction in relative risk of mortality at 2 years of age, but no significant impact on major disability, the researchers wrote.
The findings were limited by several factors including the unblinded study design, lack of data on heart rate or time to first breath, and the clamping prior to 60 seconds in 26% of infants in the delayed group based on clinical concerns for these specific infants, the researchers noted.
However, the results were strengthened by the large size, low risk of bias, and specific primary outcome, they said. The data support findings from recent systematic reviews and highlight the need for further trials to evaluate delayed clamping at different time points, with larger populations, inclusion of time to first breath and heart rate, and improved measures of disability, the researchers added.
In clinical practice, “Given that aiming to delay cord clamping for 60 seconds or more improved 2-year outcomes and short-term hematological measures with no evidence of significant harm, it seems reasonable to conclude that delayed clamping is appropriate as standard care in very preterm infants,” they concluded.
Accepting simple intervention could have great impact
This study is important in light of the overwhelming burden of preterm birth on the health care system and society as a whole, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview.
“Preterm birth is associated with billions in health care costs each year, and a large portion of that money is directed to the complications associated with preterm birth, such as early intervention services, educational support, and ongoing medical care,” Dr. Tanner said. “This study is particularly timely, as we are quickly approaching 2030, the deadline for achieving the United Nations Sustainable Development Goal of ending preventable deaths of newborns and children under 5 years of age,” she said. The goal involves “all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births. Effective treatments to reduce infant and child mortality would make strong inroads toward this goal,” she explained.
Dr. Tanner said she was not surprised by the findings because previous studies have shown similar results. “However, the large, multicenter nature of this study provides additional weight to recommendations to delay cord clamping as standard practice,” she said.
“The findings of this study support the recommendations of a number of large organizations,” said Dr. Tanner. “The World Health Organization recommends that the umbilical cord not be clamped earlier than 1 minute after birth in term or preterm infants who do not require positive pressure ventilation. The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics now recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at least 30–60 seconds after birth,” she said. “The Royal College of Obstetricians and Gynaecologists also recommends deferring umbilical cord clamping for healthy term and preterm infants for at least 2 minutes after birth,” she added.
However, “the delay in adoption of this guidelines in practice appears to be related to some concerns regarding universal adoption of this approach,” Dr. Tanner noted. “Some clinicians have suggested that delayed cord clamping could delay vital neonatal resuscitative efforts, leading to worse neonatal outcomes, but this concern has not been borne out in the data, as all guidelines specifically state that this intervention is for vigorous newborns,” she said. “In fact, in preterm infants, delayed cord clamping is associated with improved transitional circulation, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage,” Dr. Tanner emphasized. “Additionally, concerns persist that delayed cord clamping could lead to excessive transfusion with resultant polycythemia. Again, no data have supported this claim to date,” she said.
“Finally, some clinicians are concerned that delayed clamping could lead to delay in addressing maternal complications of birth such as hemorrhage, but studies have shown the opposite; delayed umbilical cord clamping has not been associated with an increased risk of postpartum hemorrhage or increased blood loss at delivery, nor has it been with a difference in the need for blood transfusion,” said Dr. Tanner.
Ideally, practitioners will become more comfortable in delaying cord clamping as a routine practice as more data demonstrating the safety and benefit of this easy intervention are disseminated, she said.
Additional research delineating which gestational ages benefit most from delayed cord clamping would help direct education efforts to implement this intervention, Dr. Tanner noted.
The study was funded by the Australian National Health and Medical Research Council. The researchers and Dr. Tanner had no financial conflicts to disclose.
FROM THE LANCET CHILD & ADOLESCENT HEALTH
Fixing the maternal health problem in the U.S.: Signs of hope?
In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. And another 60,000 have pregnancy-related or childbirth-related health issues.
Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.
In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.
“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”
“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.
As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:
U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.
At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.
A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.
President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.
Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
Best hospitals for maternity
For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.
To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.
Of those, 237 were identified as best for maternity.
As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.
On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.
The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
A call to action: Expand coverage
Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”
Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.
“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.
“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.
A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.
The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.
According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
Congressional actions
Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.
“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.
Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
Explaining and fixing the disparities
No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.
Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.
According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
When statistics hit home
Many who work to improve maternal health have gone through issues themselves or had loved ones who did.
Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.
For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.
“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”
She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.
“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.
Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.
U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.
Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.
In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.
The child’s question is understandable and heartbreaking: She wants to know where her mommy is.
“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”
A version of this article first appeared on WebMD.com.
In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. And another 60,000 have pregnancy-related or childbirth-related health issues.
Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.
In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.
“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”
“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.
As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:
U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.
At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.
A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.
President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.
Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
Best hospitals for maternity
For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.
To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.
Of those, 237 were identified as best for maternity.
As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.
On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.
The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
A call to action: Expand coverage
Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”
Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.
“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.
“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.
A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.
The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.
According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
Congressional actions
Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.
“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.
Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
Explaining and fixing the disparities
No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.
Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.
According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
When statistics hit home
Many who work to improve maternal health have gone through issues themselves or had loved ones who did.
Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.
For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.
“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”
She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.
“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.
Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.
U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.
Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.
In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.
The child’s question is understandable and heartbreaking: She wants to know where her mommy is.
“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”
A version of this article first appeared on WebMD.com.
In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. And another 60,000 have pregnancy-related or childbirth-related health issues.
Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.
In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.
“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”
“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.
As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:
U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.
At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.
A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.
President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.
Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
Best hospitals for maternity
For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.
To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.
Of those, 237 were identified as best for maternity.
As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.
On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.
The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
A call to action: Expand coverage
Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”
Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.
“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.
“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.
A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.
The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.
According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
Congressional actions
Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.
“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.
Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
Explaining and fixing the disparities
No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.
Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.
According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
When statistics hit home
Many who work to improve maternal health have gone through issues themselves or had loved ones who did.
Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.
For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.
“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”
She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.
“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.
Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.
U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.
Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.
In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.
The child’s question is understandable and heartbreaking: She wants to know where her mommy is.
“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”
A version of this article first appeared on WebMD.com.
Spice in breast milk could shape taste preferences later
They say you are what you eat, but scientists have long wondered whether breastfeeding babies are what their mothers eat, too. Their question: How much of a nursing mother’s diet eventually plays a role in a child’s food preferences later in life?
The aroma, taste, and makeup of breast milk change from day to day, based mostly on the mother’s diet. But previous research has already shown that the foods a mother eats do not directly translate into the same smells and tastes of that food in breast milk. Some substances from the mother’s diet enter her breast milk, some don’t, and even ones that do may have a different scent or flavor than what the mother experiences.
But a new study suggests that the active ingredient in black pepper makes its way into breast milk and may help the infant develop a tolerance to pepper later. The researchers published their findings in the journal Molecular Nutrition & Food Research.
Pinch of pepper
The study authors thought that maybe some food preferences could result from sensory programming that occurs through breast milk in the first few months of life. Though past studies have looked at which odor-producing substances transfer into breast milk, not many have explored specific substances that give food its distinctive flavor, or even what makes up the taste of breast milk. So they decided to investigate what happens when a mother consumes a meal containing three specific compounds: those that give pepper, chili, and ginger their particularly pungent flavors.
The researchers recruited 18 healthy, nonsmoking, nursing mothers who were producing more than enough milk for their baby’s needs. Their breastfeeding children ranged in age from 8 weeks to 1 year old. The women all ate a curry dish after having spent 2 days avoiding onion, garlic, and the spices in the curry. Then they provided pumped breast milk samples at 1, 2, and 3 hours after eating the curry.
Within an hour of the women eating the curry, the scientists were able to detect piperine, the compound that gives black pepper its bite, in the mothers’ breast milk. They did not find the compounds from ginger, chili, or curcumin – the main active ingredient in turmeric – in the breast milk. The piperine remained there for several hours, but there wasn’t enough for an adult to be able to taste it. It wasn’t possible to reliably tell whether the infants could consciously detect the flavor, but the researchers don’t think it’s likely they did.
But the scientists do suggest it’s possible that the piperine in breast milk could regularly activate a protein that detects pungent or potentially harmful substances. This is the same protein that produces the sensation of heat when eating a spicy food. If the piperine frequently activates that protein in a nursing baby at levels too low for the baby to notice, it may increase the baby’s tolerance for similar spicy substances later in life.
Ultimately, the findings suggest that .
A version of this story first appeared on WebMD.com.
They say you are what you eat, but scientists have long wondered whether breastfeeding babies are what their mothers eat, too. Their question: How much of a nursing mother’s diet eventually plays a role in a child’s food preferences later in life?
The aroma, taste, and makeup of breast milk change from day to day, based mostly on the mother’s diet. But previous research has already shown that the foods a mother eats do not directly translate into the same smells and tastes of that food in breast milk. Some substances from the mother’s diet enter her breast milk, some don’t, and even ones that do may have a different scent or flavor than what the mother experiences.
But a new study suggests that the active ingredient in black pepper makes its way into breast milk and may help the infant develop a tolerance to pepper later. The researchers published their findings in the journal Molecular Nutrition & Food Research.
Pinch of pepper
The study authors thought that maybe some food preferences could result from sensory programming that occurs through breast milk in the first few months of life. Though past studies have looked at which odor-producing substances transfer into breast milk, not many have explored specific substances that give food its distinctive flavor, or even what makes up the taste of breast milk. So they decided to investigate what happens when a mother consumes a meal containing three specific compounds: those that give pepper, chili, and ginger their particularly pungent flavors.
The researchers recruited 18 healthy, nonsmoking, nursing mothers who were producing more than enough milk for their baby’s needs. Their breastfeeding children ranged in age from 8 weeks to 1 year old. The women all ate a curry dish after having spent 2 days avoiding onion, garlic, and the spices in the curry. Then they provided pumped breast milk samples at 1, 2, and 3 hours after eating the curry.
Within an hour of the women eating the curry, the scientists were able to detect piperine, the compound that gives black pepper its bite, in the mothers’ breast milk. They did not find the compounds from ginger, chili, or curcumin – the main active ingredient in turmeric – in the breast milk. The piperine remained there for several hours, but there wasn’t enough for an adult to be able to taste it. It wasn’t possible to reliably tell whether the infants could consciously detect the flavor, but the researchers don’t think it’s likely they did.
But the scientists do suggest it’s possible that the piperine in breast milk could regularly activate a protein that detects pungent or potentially harmful substances. This is the same protein that produces the sensation of heat when eating a spicy food. If the piperine frequently activates that protein in a nursing baby at levels too low for the baby to notice, it may increase the baby’s tolerance for similar spicy substances later in life.
Ultimately, the findings suggest that .
A version of this story first appeared on WebMD.com.
They say you are what you eat, but scientists have long wondered whether breastfeeding babies are what their mothers eat, too. Their question: How much of a nursing mother’s diet eventually plays a role in a child’s food preferences later in life?
The aroma, taste, and makeup of breast milk change from day to day, based mostly on the mother’s diet. But previous research has already shown that the foods a mother eats do not directly translate into the same smells and tastes of that food in breast milk. Some substances from the mother’s diet enter her breast milk, some don’t, and even ones that do may have a different scent or flavor than what the mother experiences.
But a new study suggests that the active ingredient in black pepper makes its way into breast milk and may help the infant develop a tolerance to pepper later. The researchers published their findings in the journal Molecular Nutrition & Food Research.
Pinch of pepper
The study authors thought that maybe some food preferences could result from sensory programming that occurs through breast milk in the first few months of life. Though past studies have looked at which odor-producing substances transfer into breast milk, not many have explored specific substances that give food its distinctive flavor, or even what makes up the taste of breast milk. So they decided to investigate what happens when a mother consumes a meal containing three specific compounds: those that give pepper, chili, and ginger their particularly pungent flavors.
The researchers recruited 18 healthy, nonsmoking, nursing mothers who were producing more than enough milk for their baby’s needs. Their breastfeeding children ranged in age from 8 weeks to 1 year old. The women all ate a curry dish after having spent 2 days avoiding onion, garlic, and the spices in the curry. Then they provided pumped breast milk samples at 1, 2, and 3 hours after eating the curry.
Within an hour of the women eating the curry, the scientists were able to detect piperine, the compound that gives black pepper its bite, in the mothers’ breast milk. They did not find the compounds from ginger, chili, or curcumin – the main active ingredient in turmeric – in the breast milk. The piperine remained there for several hours, but there wasn’t enough for an adult to be able to taste it. It wasn’t possible to reliably tell whether the infants could consciously detect the flavor, but the researchers don’t think it’s likely they did.
But the scientists do suggest it’s possible that the piperine in breast milk could regularly activate a protein that detects pungent or potentially harmful substances. This is the same protein that produces the sensation of heat when eating a spicy food. If the piperine frequently activates that protein in a nursing baby at levels too low for the baby to notice, it may increase the baby’s tolerance for similar spicy substances later in life.
Ultimately, the findings suggest that .
A version of this story first appeared on WebMD.com.
FROM MOLECULAR NUTRITION & FOOD RESEARCH
Unrestricted prescribing of mifepristone: Safe and effective, says study
Abortion rates remained stable and adverse events were rare after removal of mifepristone prescribing restrictions in Canada, a new study shows.
“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a press release.
“This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions – meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when, and where they choose,” said lead author Laura Schummers, ScD, a postdoctoral fellow in the same department.
The findings “add to the accumulating evidence that removing restrictions from medication abortion is safe, effective, and improves access,” agreed Eve Espey, MD, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, who was not part of the research team. “This is additional confirmation that it is safe for patients to receive abortion care medications in the ‘normal’ fashion, through a prescription available at a pharmacy,” she said in an interview.
The study, published in the New England Journal of Medicine, compared medical abortion use, safety, and effectiveness in the province of Ontario before the Canadian availability of mifepristone and after it became available without restrictions that are similar to the Risk Evaluation and Mitigation Strategy (REMS) restrictions in place for mifepristone in the United States.
Using linked administrative health data, the researchers created a population-based cohort of all Ontario residents aged 12-49 years who had received abortion services during the study period. In total, 195,183 abortions were performed in the period before mifepristone was approved (January 2012–December 2016), and 84,032 were performed after it was made available without restrictions (Nov. 7, 2017, through March 15, 2020). The vast majority of these abortions (89.3%) were surgical, with about 10% being medically induced, the authors reported.
The study found that, while the overall abortion rate declined over the study period (from 11.9 to 11.3 per 1,000 female residents), the proportion of medical abortions jumped sharply from 2.2% to 31.4%, and the rate of second-trimester abortions declined from 5.5% of all abortions to 5.1%.
Abortion safety outcomes within 6 weeks of abortion remained stable over the two study periods. This included severe adverse events (0.03% vs. 0.04%) such as blood transfusions, abdominal surgery, admission to an ICU, or sepsis during an abortion-related hospitalization; and complications (0.74% vs. 0.69%,) such as genital tract or pelvic infection, hemorrhage, embolism, shock, renal failure, damage to pelvic organs or tissues, and venous complications among other things.
There were slight declines in overall abortion effectiveness, but ongoing pregnancy rates “remained infrequent,” the authors noted. While there was a modest rise in the rates of subsequent uterine evacuation (from 1.0% to 2.2%), and ongoing intrauterine pregnancy continuing until delivery (from 0.03% to 0.08%), the rate of ectopic pregnancy diagnosed within 6 weeks after the abortion date remained stable (from 0.15% to 0.22%).
Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone, according to the press release. And while professional organizations have called for the removal of such restrictions “because they impede access to abortion services without improving safety,” high-quality data on this are lacking, they added.
The study’s finding are consistent with existing U.S. and U.K. data showing Food and Drug Administration REMS restrictions requiring abortion care medications to be dispensed in a clinic by a certified provider “are unnecessary and create obstacles to early abortion access,” said Dr. Espey. “For clinicians and patients in the U.S., it’s important to note that the increasing number of legislative restrictions on abortion, including medication abortion, are non–evidence based. Politically motivated false claims of safety concerns are countered by this study and others conducted during the pandemic when both the U.S. and U.K. removed REMS-type restrictions. These studies show that receiving abortion care through usual pharmacy channels and through telemedicine is safe, effective, and reduces barriers to care.”
Dr. Norman reported receiving grants from the Canadian Institutes of Health Research, providing expert witness services to the government of Ontario and Office of the Attorney General, and serving on the board of directors of the Society of Family Planning. No other researchers reported conflicts of interest. Dr. Espey reported no conflicts of interest. The Canadian Institutes of Health Research and the Women’s Health Research Institute with the support of ICES (formerly known as the Institute for Clinical Evaluative Sciences).
Abortion rates remained stable and adverse events were rare after removal of mifepristone prescribing restrictions in Canada, a new study shows.
“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a press release.
“This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions – meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when, and where they choose,” said lead author Laura Schummers, ScD, a postdoctoral fellow in the same department.
The findings “add to the accumulating evidence that removing restrictions from medication abortion is safe, effective, and improves access,” agreed Eve Espey, MD, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, who was not part of the research team. “This is additional confirmation that it is safe for patients to receive abortion care medications in the ‘normal’ fashion, through a prescription available at a pharmacy,” she said in an interview.
The study, published in the New England Journal of Medicine, compared medical abortion use, safety, and effectiveness in the province of Ontario before the Canadian availability of mifepristone and after it became available without restrictions that are similar to the Risk Evaluation and Mitigation Strategy (REMS) restrictions in place for mifepristone in the United States.
Using linked administrative health data, the researchers created a population-based cohort of all Ontario residents aged 12-49 years who had received abortion services during the study period. In total, 195,183 abortions were performed in the period before mifepristone was approved (January 2012–December 2016), and 84,032 were performed after it was made available without restrictions (Nov. 7, 2017, through March 15, 2020). The vast majority of these abortions (89.3%) were surgical, with about 10% being medically induced, the authors reported.
The study found that, while the overall abortion rate declined over the study period (from 11.9 to 11.3 per 1,000 female residents), the proportion of medical abortions jumped sharply from 2.2% to 31.4%, and the rate of second-trimester abortions declined from 5.5% of all abortions to 5.1%.
Abortion safety outcomes within 6 weeks of abortion remained stable over the two study periods. This included severe adverse events (0.03% vs. 0.04%) such as blood transfusions, abdominal surgery, admission to an ICU, or sepsis during an abortion-related hospitalization; and complications (0.74% vs. 0.69%,) such as genital tract or pelvic infection, hemorrhage, embolism, shock, renal failure, damage to pelvic organs or tissues, and venous complications among other things.
There were slight declines in overall abortion effectiveness, but ongoing pregnancy rates “remained infrequent,” the authors noted. While there was a modest rise in the rates of subsequent uterine evacuation (from 1.0% to 2.2%), and ongoing intrauterine pregnancy continuing until delivery (from 0.03% to 0.08%), the rate of ectopic pregnancy diagnosed within 6 weeks after the abortion date remained stable (from 0.15% to 0.22%).
Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone, according to the press release. And while professional organizations have called for the removal of such restrictions “because they impede access to abortion services without improving safety,” high-quality data on this are lacking, they added.
The study’s finding are consistent with existing U.S. and U.K. data showing Food and Drug Administration REMS restrictions requiring abortion care medications to be dispensed in a clinic by a certified provider “are unnecessary and create obstacles to early abortion access,” said Dr. Espey. “For clinicians and patients in the U.S., it’s important to note that the increasing number of legislative restrictions on abortion, including medication abortion, are non–evidence based. Politically motivated false claims of safety concerns are countered by this study and others conducted during the pandemic when both the U.S. and U.K. removed REMS-type restrictions. These studies show that receiving abortion care through usual pharmacy channels and through telemedicine is safe, effective, and reduces barriers to care.”
Dr. Norman reported receiving grants from the Canadian Institutes of Health Research, providing expert witness services to the government of Ontario and Office of the Attorney General, and serving on the board of directors of the Society of Family Planning. No other researchers reported conflicts of interest. Dr. Espey reported no conflicts of interest. The Canadian Institutes of Health Research and the Women’s Health Research Institute with the support of ICES (formerly known as the Institute for Clinical Evaluative Sciences).
Abortion rates remained stable and adverse events were rare after removal of mifepristone prescribing restrictions in Canada, a new study shows.
“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a press release.
“This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions – meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when, and where they choose,” said lead author Laura Schummers, ScD, a postdoctoral fellow in the same department.
The findings “add to the accumulating evidence that removing restrictions from medication abortion is safe, effective, and improves access,” agreed Eve Espey, MD, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, who was not part of the research team. “This is additional confirmation that it is safe for patients to receive abortion care medications in the ‘normal’ fashion, through a prescription available at a pharmacy,” she said in an interview.
The study, published in the New England Journal of Medicine, compared medical abortion use, safety, and effectiveness in the province of Ontario before the Canadian availability of mifepristone and after it became available without restrictions that are similar to the Risk Evaluation and Mitigation Strategy (REMS) restrictions in place for mifepristone in the United States.
Using linked administrative health data, the researchers created a population-based cohort of all Ontario residents aged 12-49 years who had received abortion services during the study period. In total, 195,183 abortions were performed in the period before mifepristone was approved (January 2012–December 2016), and 84,032 were performed after it was made available without restrictions (Nov. 7, 2017, through March 15, 2020). The vast majority of these abortions (89.3%) were surgical, with about 10% being medically induced, the authors reported.
The study found that, while the overall abortion rate declined over the study period (from 11.9 to 11.3 per 1,000 female residents), the proportion of medical abortions jumped sharply from 2.2% to 31.4%, and the rate of second-trimester abortions declined from 5.5% of all abortions to 5.1%.
Abortion safety outcomes within 6 weeks of abortion remained stable over the two study periods. This included severe adverse events (0.03% vs. 0.04%) such as blood transfusions, abdominal surgery, admission to an ICU, or sepsis during an abortion-related hospitalization; and complications (0.74% vs. 0.69%,) such as genital tract or pelvic infection, hemorrhage, embolism, shock, renal failure, damage to pelvic organs or tissues, and venous complications among other things.
There were slight declines in overall abortion effectiveness, but ongoing pregnancy rates “remained infrequent,” the authors noted. While there was a modest rise in the rates of subsequent uterine evacuation (from 1.0% to 2.2%), and ongoing intrauterine pregnancy continuing until delivery (from 0.03% to 0.08%), the rate of ectopic pregnancy diagnosed within 6 weeks after the abortion date remained stable (from 0.15% to 0.22%).
Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone, according to the press release. And while professional organizations have called for the removal of such restrictions “because they impede access to abortion services without improving safety,” high-quality data on this are lacking, they added.
The study’s finding are consistent with existing U.S. and U.K. data showing Food and Drug Administration REMS restrictions requiring abortion care medications to be dispensed in a clinic by a certified provider “are unnecessary and create obstacles to early abortion access,” said Dr. Espey. “For clinicians and patients in the U.S., it’s important to note that the increasing number of legislative restrictions on abortion, including medication abortion, are non–evidence based. Politically motivated false claims of safety concerns are countered by this study and others conducted during the pandemic when both the U.S. and U.K. removed REMS-type restrictions. These studies show that receiving abortion care through usual pharmacy channels and through telemedicine is safe, effective, and reduces barriers to care.”
Dr. Norman reported receiving grants from the Canadian Institutes of Health Research, providing expert witness services to the government of Ontario and Office of the Attorney General, and serving on the board of directors of the Society of Family Planning. No other researchers reported conflicts of interest. Dr. Espey reported no conflicts of interest. The Canadian Institutes of Health Research and the Women’s Health Research Institute with the support of ICES (formerly known as the Institute for Clinical Evaluative Sciences).
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Booster recommendations for pregnant women, teens, and other groups explained
These recommendations have been widened because of the continued emergence of new variants of the virus and the wane of protection over time for both vaccinations and previous disease.
The new recommendations take away some of the questions surrounding eligibility for booster vaccinations while potentially leaving some additional questions. All in all, they provide flexibility for individuals to help protect themselves against the COVID-19 virus, as many are considering celebrating the holidays with friends and family.
The first item that has become clear is that all individuals over 18 are now not only eligible for a booster vaccination a certain time after they have completed their series, but have a recommendation for one.1
But what about a fourth dose? There is a possibility that some patients should be receiving one. For those who require a three-dose series due to a condition that makes them immunocompromised, they should receive their booster vaccination six months after completion of the three-dose series. This distinction may cause confusion for some, but is important for those immunocompromised.
Boosters in women who are pregnant
The recommendations also include specific comments about individuals who are pregnant. Although initial studies did not include pregnant individuals, there has been increasing real world data that vaccination against COVID, including booster vaccinations, is safe and recommended. As pregnancy increases the risk of severe disease if infected by COVID-19, both the CDC and the American College of Obstetricians and Gynecologists,2 along with other specialty organizations, such as the Royal College of Obstetricians and Gynaecologists, recommend vaccinations for pregnant individuals.
The CDC goes on to describe that there is no evidence of vaccination increasing the risk of infertility. The vaccine protects the pregnant individual and also provides protection to the baby once born. The same is true of breastfeeding individuals.3
I hope that this information allows physicians to feel comfortable recommending vaccinations and boosters to those who are pregnant and breast feeding.
Expanded recommendations for those aged 16-17 years
Recently, the CDC also expanded booster recommendations to include those aged 16-17 years, 6 months after completing their vaccine series.
Those under 18 are currently only able to receive the Pfizer-BioNtech vaccine. This new guidance has left some parents wondering if there will also be approval for booster vaccinations soon for those aged 12-16 who are approaching or have reached six months past the initial vaccine.1
Booster brand for those over 18 years?
Although the recommendation has been simplified for all over age 18 years, there is still a decision to be made about which vaccine to use as the booster.
The recommendations allow individuals to decide which brand of vaccine they would like to have as a booster. They may choose to be vaccinated with the same vaccine they originally received or with a different vaccine. This vaccine flexibility may cause confusion, but ultimately is a good thing as it allows individuals to receive whatever vaccine is available and most convenient. This also allows individuals who have been vaccinated outside of the United States by a different brand of vaccine to also receive a booster vaccination with one of the options available here.
Take home message
Overall, the expansion of booster recommendations will help everyone avoid severe disease from COVID-19 infections. Physicians now have more clarity on who should be receiving these vaccines. Along with testing, masking, and appropriate distancing, these recommendations should help prevent severe disease and death from COVID-19.
Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program, also in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.
References
1. COVID-19 Vaccine Booster Shots. Centers for Disease Control and Prevention. 2021 Dec 9.
2. COVID-19 Vaccines and Pregnancy: Conversation Guide. American College of Obstetricians and Gynecologists. 2021 November.
3. COVID-19 Vaccines While Pregnant or Breastfeeding. Centers for Disease Control and Prevention. 2021 Dec 6.
These recommendations have been widened because of the continued emergence of new variants of the virus and the wane of protection over time for both vaccinations and previous disease.
The new recommendations take away some of the questions surrounding eligibility for booster vaccinations while potentially leaving some additional questions. All in all, they provide flexibility for individuals to help protect themselves against the COVID-19 virus, as many are considering celebrating the holidays with friends and family.
The first item that has become clear is that all individuals over 18 are now not only eligible for a booster vaccination a certain time after they have completed their series, but have a recommendation for one.1
But what about a fourth dose? There is a possibility that some patients should be receiving one. For those who require a three-dose series due to a condition that makes them immunocompromised, they should receive their booster vaccination six months after completion of the three-dose series. This distinction may cause confusion for some, but is important for those immunocompromised.
Boosters in women who are pregnant
The recommendations also include specific comments about individuals who are pregnant. Although initial studies did not include pregnant individuals, there has been increasing real world data that vaccination against COVID, including booster vaccinations, is safe and recommended. As pregnancy increases the risk of severe disease if infected by COVID-19, both the CDC and the American College of Obstetricians and Gynecologists,2 along with other specialty organizations, such as the Royal College of Obstetricians and Gynaecologists, recommend vaccinations for pregnant individuals.
The CDC goes on to describe that there is no evidence of vaccination increasing the risk of infertility. The vaccine protects the pregnant individual and also provides protection to the baby once born. The same is true of breastfeeding individuals.3
I hope that this information allows physicians to feel comfortable recommending vaccinations and boosters to those who are pregnant and breast feeding.
Expanded recommendations for those aged 16-17 years
Recently, the CDC also expanded booster recommendations to include those aged 16-17 years, 6 months after completing their vaccine series.
Those under 18 are currently only able to receive the Pfizer-BioNtech vaccine. This new guidance has left some parents wondering if there will also be approval for booster vaccinations soon for those aged 12-16 who are approaching or have reached six months past the initial vaccine.1
Booster brand for those over 18 years?
Although the recommendation has been simplified for all over age 18 years, there is still a decision to be made about which vaccine to use as the booster.
The recommendations allow individuals to decide which brand of vaccine they would like to have as a booster. They may choose to be vaccinated with the same vaccine they originally received or with a different vaccine. This vaccine flexibility may cause confusion, but ultimately is a good thing as it allows individuals to receive whatever vaccine is available and most convenient. This also allows individuals who have been vaccinated outside of the United States by a different brand of vaccine to also receive a booster vaccination with one of the options available here.
Take home message
Overall, the expansion of booster recommendations will help everyone avoid severe disease from COVID-19 infections. Physicians now have more clarity on who should be receiving these vaccines. Along with testing, masking, and appropriate distancing, these recommendations should help prevent severe disease and death from COVID-19.
Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program, also in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.
References
1. COVID-19 Vaccine Booster Shots. Centers for Disease Control and Prevention. 2021 Dec 9.
2. COVID-19 Vaccines and Pregnancy: Conversation Guide. American College of Obstetricians and Gynecologists. 2021 November.
3. COVID-19 Vaccines While Pregnant or Breastfeeding. Centers for Disease Control and Prevention. 2021 Dec 6.
These recommendations have been widened because of the continued emergence of new variants of the virus and the wane of protection over time for both vaccinations and previous disease.
The new recommendations take away some of the questions surrounding eligibility for booster vaccinations while potentially leaving some additional questions. All in all, they provide flexibility for individuals to help protect themselves against the COVID-19 virus, as many are considering celebrating the holidays with friends and family.
The first item that has become clear is that all individuals over 18 are now not only eligible for a booster vaccination a certain time after they have completed their series, but have a recommendation for one.1
But what about a fourth dose? There is a possibility that some patients should be receiving one. For those who require a three-dose series due to a condition that makes them immunocompromised, they should receive their booster vaccination six months after completion of the three-dose series. This distinction may cause confusion for some, but is important for those immunocompromised.
Boosters in women who are pregnant
The recommendations also include specific comments about individuals who are pregnant. Although initial studies did not include pregnant individuals, there has been increasing real world data that vaccination against COVID, including booster vaccinations, is safe and recommended. As pregnancy increases the risk of severe disease if infected by COVID-19, both the CDC and the American College of Obstetricians and Gynecologists,2 along with other specialty organizations, such as the Royal College of Obstetricians and Gynaecologists, recommend vaccinations for pregnant individuals.
The CDC goes on to describe that there is no evidence of vaccination increasing the risk of infertility. The vaccine protects the pregnant individual and also provides protection to the baby once born. The same is true of breastfeeding individuals.3
I hope that this information allows physicians to feel comfortable recommending vaccinations and boosters to those who are pregnant and breast feeding.
Expanded recommendations for those aged 16-17 years
Recently, the CDC also expanded booster recommendations to include those aged 16-17 years, 6 months after completing their vaccine series.
Those under 18 are currently only able to receive the Pfizer-BioNtech vaccine. This new guidance has left some parents wondering if there will also be approval for booster vaccinations soon for those aged 12-16 who are approaching or have reached six months past the initial vaccine.1
Booster brand for those over 18 years?
Although the recommendation has been simplified for all over age 18 years, there is still a decision to be made about which vaccine to use as the booster.
The recommendations allow individuals to decide which brand of vaccine they would like to have as a booster. They may choose to be vaccinated with the same vaccine they originally received or with a different vaccine. This vaccine flexibility may cause confusion, but ultimately is a good thing as it allows individuals to receive whatever vaccine is available and most convenient. This also allows individuals who have been vaccinated outside of the United States by a different brand of vaccine to also receive a booster vaccination with one of the options available here.
Take home message
Overall, the expansion of booster recommendations will help everyone avoid severe disease from COVID-19 infections. Physicians now have more clarity on who should be receiving these vaccines. Along with testing, masking, and appropriate distancing, these recommendations should help prevent severe disease and death from COVID-19.
Dr. Wheat is a family physician at Erie Family Health Center in Chicago. She is program director of Northwestern’s McGaw Family Medicine residency program, also in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at fpnews@mdedge.com.
References
1. COVID-19 Vaccine Booster Shots. Centers for Disease Control and Prevention. 2021 Dec 9.
2. COVID-19 Vaccines and Pregnancy: Conversation Guide. American College of Obstetricians and Gynecologists. 2021 November.
3. COVID-19 Vaccines While Pregnant or Breastfeeding. Centers for Disease Control and Prevention. 2021 Dec 6.
Supreme Court leaves Texas abortion law in place
In a highly anticipated decision, the U.S. Supreme Court ruled Dec. 10 that the controversial Texas abortion law that restricts the procedure to women pregnant for 6 weeks or less may continue to be enforced, but allowed for state and federal courts to hear challenges to whether it violates the Constitution.
As anti-abortion organizations celebrate and abortion rights groups confer on what the decision could mean for women not only in Texas but across the United States, there is another, bigger implication as well.
The Texas law generated a lot of controversy, in part, because it took an unusual approach. In authorizing essentially anyone across the nation to file a lawsuit against a woman in the lone star state who seeks the procedure outside the law, or anyone who assists her -- including healthcare professionals, it opens up the potential for similar legal challenges to other Supreme Court rulings on marriage, guns, and other rights.
The vote was 5-4, with Chief Justice John Roberts joining the liberal members of the court in dissenting.
The ruling allows abortion rights supporters to sue in state court, where a Texas judge on Dec. 9 ruled the law unconstitutional. He stopped short, however, of issuing an injunction against. Abortion rights opponents have vowed to appeal District Judge David Peeples’ ruling.
A timeline on the case
The law took effect on Sept. 1, 2021. The day before, the Supreme Court did not act to put a hold on the law as requested by abortion rights organizations. As a result, many Texas women seeking the procedure after 6 weeks traveled to nearby states. On Oct. 25, the Court agreed to hear a challenge to the law by the Biden Administration.
The Dec. 10 Supreme Court decision to uphold the Texas law contrasts with a general consensus among many legal observers that the justices were receptive to blocking the law, based on questions and issues the judges raised during oral arguments on Nov. 1, 2021.
A separate legal challenge to abortion rights involves a Mississippi law banning the procedure starting at 15 weeks of pregnancy. The Supreme Court justices scheduled oral arguments in that case for Dec. 1, and are expected to issue a ruling in that case in June 2022.
A version of this article first appeared on WebMD.com .
In a highly anticipated decision, the U.S. Supreme Court ruled Dec. 10 that the controversial Texas abortion law that restricts the procedure to women pregnant for 6 weeks or less may continue to be enforced, but allowed for state and federal courts to hear challenges to whether it violates the Constitution.
As anti-abortion organizations celebrate and abortion rights groups confer on what the decision could mean for women not only in Texas but across the United States, there is another, bigger implication as well.
The Texas law generated a lot of controversy, in part, because it took an unusual approach. In authorizing essentially anyone across the nation to file a lawsuit against a woman in the lone star state who seeks the procedure outside the law, or anyone who assists her -- including healthcare professionals, it opens up the potential for similar legal challenges to other Supreme Court rulings on marriage, guns, and other rights.
The vote was 5-4, with Chief Justice John Roberts joining the liberal members of the court in dissenting.
The ruling allows abortion rights supporters to sue in state court, where a Texas judge on Dec. 9 ruled the law unconstitutional. He stopped short, however, of issuing an injunction against. Abortion rights opponents have vowed to appeal District Judge David Peeples’ ruling.
A timeline on the case
The law took effect on Sept. 1, 2021. The day before, the Supreme Court did not act to put a hold on the law as requested by abortion rights organizations. As a result, many Texas women seeking the procedure after 6 weeks traveled to nearby states. On Oct. 25, the Court agreed to hear a challenge to the law by the Biden Administration.
The Dec. 10 Supreme Court decision to uphold the Texas law contrasts with a general consensus among many legal observers that the justices were receptive to blocking the law, based on questions and issues the judges raised during oral arguments on Nov. 1, 2021.
A separate legal challenge to abortion rights involves a Mississippi law banning the procedure starting at 15 weeks of pregnancy. The Supreme Court justices scheduled oral arguments in that case for Dec. 1, and are expected to issue a ruling in that case in June 2022.
A version of this article first appeared on WebMD.com .
In a highly anticipated decision, the U.S. Supreme Court ruled Dec. 10 that the controversial Texas abortion law that restricts the procedure to women pregnant for 6 weeks or less may continue to be enforced, but allowed for state and federal courts to hear challenges to whether it violates the Constitution.
As anti-abortion organizations celebrate and abortion rights groups confer on what the decision could mean for women not only in Texas but across the United States, there is another, bigger implication as well.
The Texas law generated a lot of controversy, in part, because it took an unusual approach. In authorizing essentially anyone across the nation to file a lawsuit against a woman in the lone star state who seeks the procedure outside the law, or anyone who assists her -- including healthcare professionals, it opens up the potential for similar legal challenges to other Supreme Court rulings on marriage, guns, and other rights.
The vote was 5-4, with Chief Justice John Roberts joining the liberal members of the court in dissenting.
The ruling allows abortion rights supporters to sue in state court, where a Texas judge on Dec. 9 ruled the law unconstitutional. He stopped short, however, of issuing an injunction against. Abortion rights opponents have vowed to appeal District Judge David Peeples’ ruling.
A timeline on the case
The law took effect on Sept. 1, 2021. The day before, the Supreme Court did not act to put a hold on the law as requested by abortion rights organizations. As a result, many Texas women seeking the procedure after 6 weeks traveled to nearby states. On Oct. 25, the Court agreed to hear a challenge to the law by the Biden Administration.
The Dec. 10 Supreme Court decision to uphold the Texas law contrasts with a general consensus among many legal observers that the justices were receptive to blocking the law, based on questions and issues the judges raised during oral arguments on Nov. 1, 2021.
A separate legal challenge to abortion rights involves a Mississippi law banning the procedure starting at 15 weeks of pregnancy. The Supreme Court justices scheduled oral arguments in that case for Dec. 1, and are expected to issue a ruling in that case in June 2022.
A version of this article first appeared on WebMD.com .