OBG Management

Illustration: Kimberly Martens for OBG Management

Sexual function is a complex, multifaceted process mediated by neurologic functions, hormonal regulation, and psychological factors. What could possibly go wrong?

As it turns out, quite a lot. Female sexual dysfunction is a common, vastly undertreated sexual health problem that can have wide-reaching effects on a woman’s life. These effects may include impaired body image, self-confidence, and self-worth. Sexual dysfunction also can contribute to relationship dissatisfaction and leave one feeling less connected with her partner.^1,2 Studies have shown women with sexual dysfunction have higher health care expenditures³ and that depression and fatigue are common comorbidities, as is frequently seen in other chronic conditions such as diabetes and back pain.⁴

Understanding the pathogenesis of female sexual dysfunction helps to guide our approach to its management. Indeed, increased understanding of its pathology has helped to usher in new and emerging treatment options, as well as a personalized, biopsychosocial approach to its management.

Related article:
2016 Update on female sexual dysfunction

In this Update, I discuss the interplay of physiologic and psychological factors that affect female sexual function as well as the latest options for its management. I have also assembled a panel of experts to discuss 2 cases representative of sexual dysfunction that you may encounter in your clinical practice and how prescribing decisions are made for their management.

Read about factors that impact sexual function and agents to help manage dysfunction.

Multiple transmitters in the brain can increase or decrease sexual desire and function

Neurotransmitters involved in sexual excitation include brain dopamine, melanocortin, oxytocin, vasopressin, and norepinephrine, whereas brain opioids, serotonin, prolactin, and endocannabinoids function as sexual inhibitors. Inhibitory transmitters are activated normally during sexual refractoriness but also from primary aversion or secondary avoidance disorders.¹ Drugs or conditions that reduce brain dopamine levels, increase the action of brain serotonin, or enhance brain opioid pathways have been shown to inhibit sexual desire, while those that increase hypothalamic and mesolimbic dopamine or decrease serotonin release have been shown to stimulate sexual desire.¹ 

Estradiol and progesterone can impact sexual function and desire

In addition to the neurotransmitters, hormones are important modulators of female sexual function. Decreasing levels of circulating estrogen after menopause lead to physiologic, biologic, and clinical changes in the urogenital tissues, such as decreased elastin, thinning of the epithelium, reduced vaginal blood flow, diminished lubrication, and decreased flexibility and elasticity. These changes result in the symptoms of genitourinary syndrome of menopause (GSM), which affects as many as half of all menopausal women.^5,6 In clinical trials, dyspareunia and vaginal dryness are the most bothersome GSM symptoms reported.⁷

The role of hormonal regulation in sexual dysfunction among premenopausal women is not yet fully understood, but we do know that estradiol has been shown to improve sexual desire, progesterone tends to dampen sexual desire, and that testosterone at physiological levels has been shown in most studies to have a neutral effect on sexual desire in a well-estrogenized patient.⁸

Related article:
Focus on treating genital atrophy symptoms

Experience and behavior modulate or reinforce sexual dysfunction

The most common psychological factors that trigger or amplify female sexual dysfunction are depression, anxiety, distraction, negative body image, sexual abuse, and emotional neglect.⁹ Contextual or sociocultural factors, such as relationship discord, life-stage stressors (the empty nest syndrome or anxiety and sleep deprivation from a new baby), as well as cultural or religious values that suppress sexuality, also should be considered.⁹ Experience-based neuroplasticity (changes in brain pathways that become solidified by negative or positive experiences) may elucidate how a multimodal approach, utilizing medical and psychological treatment, can be beneficial for patients, particularly those with hypoactive sexual desire disorder (HSDD).¹

New and emerging approaches to managing female sexual dysfunction

Three agents, one of which has been available for prescription for some time, one that is newly available, and one in the pipeline, are or may soon be in the gynecologist's armamentarium.

Flibanserin

Medications that target excitatory pathways or blunt inhibitory pathways are in development, and one, flibanserin (Addyi), has been US Food and Drug Administration (FDA)-approved for the treatment of acquired, generalized HSDD in premenopausal women.^1,10 Flibanserin is a nonhormonal, centrally acting, postsynaptic serotonin 1A receptor agonist and a serotonin 2A receptor antagonist that is taken daily at bedtime (100 mg); several weeks are usually needed before any effects are noted.¹ It is not approved for postmenopausal women and has a boxed warning about the risks of hypotension and syncope; its use is contraindicated in women who drink alcohol, in those who have hepatic impairment, and with the use of moderate or strong CYP3A4 inhibitors.¹¹

Also keep in mind that flibanserin is only available through a Risk Evaluation and Mitigation Strategy program, so clinicians who wish to prescribe it must enroll in and complete training to become certified providers.⁹

Related article:
What you need to know (and do) to prescribe the new drug flibanserin

Prasterone

Prasterone (Intrarosa), a once-daily intravaginal dehydroepiandrosterone (DHEA) product, is a prohormone that increases local estrogen and testosterone and has the advantage of improved sexual function, desire, arousal, lubrication, orgasm, satisfaction, as well as pain at sexual activity.¹² It was approved by the FDA in November 2016 to treat moderate to severe dyspareunia and has been available for prescribing since July 2017. Its cost is comparable to topical estrogen products, with a $25 copay program.

Because prasterone is not an estrogen, it does not have the boxed warning that all estrogen products are mandated by the FDA to have. This may make it more acceptable to patients, who often decline to use an estrogen product after seeing the boxed warning on the package. The Centers for Medicare and Medicaid Services (CMS) does not have prasterone on its list of potentially hazardous drugs for the elderly. However, keep in mind that because its label is for dyspareunia and not specifically for GSM, CMS considers it a drug of choice--in other words, like sildenafil (Viagra), a lifestyle choice and not for treatment of a medical condition. As such, at the present time, Medicare does not cover it.

Bremelanotide

Late-stage trials of bremelanotide, a melanocortin receptor agonist, are underway. Its mechanism of action is somewhat like that of flibanserin in that both drugs increase dopamine and norepinephrine levels. The advantage of bremelanotide is that it is used as needed. It is dosed subcutaneously (1.75 mg) and it can be used as often as a woman would like to use it. The FDA is expected to consider it for approval in about a year. Unpublished data from poster sessions at recent meetings show that, in a phase 3 study of 1,247 premenopausal women with HSDD (who had already been screened for depression and were found to have a physiologic condition), improvements in desire, arousal, lubrication, and orgasm were shown with bremelanotide. About 18% of women stopped using the drug because of adverse effects (nausea, vomiting, flushing, or headache) versus 2% for placebo. Like flibanserin, it is expected to be approved for premenopausal women only. 

Read how 3 experts would manage differing GSM symptoms.

What would you prescribe for these patients? 

CASE Genitourinary syndrome of menopause (GSM) in a 55-year-old woman

A 55-year-old widow is beginning a new relationship. She has not had partnered sexual activity for several years, but she recently has begun a relationship. She describes pain with attempted penetration with her new partner. Her last menstrual period was 3 years ago and she has experienced very minor menopausal symptoms, which are not bothersome. On examination, the vulva and vagina are pale, with thin epithelium and absent rugae. The tissue lacks elasticity. A virginal speculum is needed to visualize the cervix.

How would you go about deciding which of the many options for management of GSM you will recommend for this patient? What do you weigh as you consider DHEA versus estrogen and topical versus oral therapy?
 
JoAnn V. Pinkerton, MD: Vulvovaginal atrophy (VVA), part of GSM, is associated with postmenopausal estrogen deficiency and includes the signs and symptoms seen on this patient's physical exam: vaginal narrowing, pallor, loss of elasticity, as well as pain with intercourse.⁶ Estrogen therapy is the most effective treatment for vaginal atrophy.¹³ Since she does not have significant menopausal symptoms, low-dose vaginal estrogen preparations are effective and generally safe treatments for VVA; these include creams, tablets containing estradiol or conjugated equine estrogen (CEE), and a low-dose vaginal estradiol ring--all available at doses that result in minimal systemic absorption.

Choice is usually made based on patient desire and likely adherence. If the patient prefers nonestrogen therapies that improve VVA and have been approved for relief of dyspareunia in postmenopausal women, I would discuss with the patient the oral selective estrogen receptor modulator ospemifene,¹⁴ and the new intravaginal DHEA suppositories, prasterone.¹⁵ Ospemifene is taken daily as an oral tablet, has a small risk of blood clots, and is my choice for women who do not need systemic hormone therapy and prefer to avoid vaginal therapy.

Andrew M. Kaunitz, MD: GSM is prevalent in menopausal women and, if not treated, causes progressive vaginal dryness and sexual discomfort. When the main indication for hormonal management in a menopausal woman is GSM (as opposed to treatment of vasomotor symptoms or prevention of osteoporosis), the treatment of choice is low-dose local vaginal estrogen, ospemifene, or prasterone (DHEA). Prasterone is a vaginally administered nonestrogen steroid that was approved by the FDA to treat dyspareunia associated with GSM. DHEA is an endogenous inactive steroid that is converted locally into androgens and estrogens; one vaginal insert is placed nightly.^16,17

This 55-year-old widow has not been sexually active for some time. The facts that attempted penetration was painful and only an ultrathin (virginal) speculum could be used for examination indicate that contraction of the pelvic floor muscles is likely present. Simply starting medical management may not lead to comfortable/successful penetrative sex for this woman. In addition to  medical management, she would likely benefit from referral for physical therapy. Using dilators and other strategies, along with the positive impact that medical management will have on the vaginal mucosa, a woman's physical therapist can work with this patient to help the pelvic floor muscles relax and facilitate comfortable penetrative sex.

James A. Simon, MD: With only minor vasomotor symptoms, I would assess the other potential benefits of a systemic therapy. These might include cardiovascular risk reduction (systemic estrogens or estrogens/progesterone in some), breast cancer risk reduction (some data suggesting ospemifene can accomplish this), osteoporosis prevention (systemic estrogens and estrogen/androgens), etc. If there is an option for a treatment to address more than one symptom, in this case GSM, assessing the risks/benefits of each of these therapies should be estimated for this specific patient.

If there are no systemic benefits to be had, then any of the local treatments should be helpful. As there are no head-to-head comparisons available, local estrogen cream, tablets, rings, local DHEA, or systemic ospemifene each should be considered possible treatments. I also feel this patient may benefit from supplementary self-dilation and/or physical therapy.

Related article:
2017 Update on menopause

 
CASE Dyspareunia and vasomotor symptoms in a 42-year-old breast cancer survivor

A 42-year-old woman with a BRCA1 mutation has undergone prophylactic mastectomies as well as hysterectomy with bilateral salpingo-oophorectomy. She reports mild to moderate hot flashes and bothersome vaginal dryness and dyspareunia. Examination confirms GSM.

Would you advise systemic hormone therapy for this patient? What would your recommendation be for management of her GSM symptoms?

Dr. Simon: While one's gut reaction would be to avoid systemic estrogen therapy in a patient with a BRCA1 mutation, the scientific information confirming this fear is lacking.¹⁸ Such patients may benefit significantly from systemic estrogen therapy (reduced risk of cardiovascular disease and cognitive decline, etc.), and with both breasts and both ovaries removed, estrogen's breast cancer risks, if any in this population, are largely avoided. The patient also may benefit from additional local therapy with either estrogens or DHEA.

Dr. Kaunitz: Due to her high lifetime risk of breast and ovarian cancer, this woman has proceeded with risk-reducing breast and gynecologic surgery. As more BRCA mutation carriers are being identified and undergo risk-reducing bilateral mastectomy (usually with reconstruction) and salpingo-oophorectomy, clinicians and mutation carriers more frequently face decisions regarding use of systemic hormone therapy.

Mutation carriers who have undergone bilateral risk-reducing mastectomy experience a very low baseline future risk for breast cancer; accordingly, concerns regarding this disease should not prevent use of systemic hormone therapy. Furthermore, without hormone replacement, induced menopause in women this age is associated with an elevated risk of osteoporosis, persistent vasomotor symptoms, cardiovascular disease, stroke, mood changes, dementia, Parkinson disease, and overall mortality. Recognizing the safety of estrogen therapy in this setting, this 42-year-old BRCA1 mutation carrier can initiate estrogen therapy. Standard dose estrogen therapy refers to oral estradiol 1.0 mg, conjugated equine estrogen 0.625 mg,or transdermal estradiol 0.05 mg. In younger women like this 42-year-old with surgically induced menopause, higher than standard replacement doses of estrogen are often appropriate.¹⁷

Due to concerns the hormone therapy might further increase future risk of breast cancer, some mutation carriers may delay or avoid risk-reducing bilateral salpingo-oophorectomy, a potentially lifesaving surgery which reduces not only future risk of ovarian cancer but also future risk for breast cancer.

Among mutation carriers with intact breasts, several studies address risk of breast cancer with use of systemic hormone therapy. Although limited in numbers of participants and years of follow-up, in aggregate, these studies provide reassurance that short-term use of systemic hormone therapy does not increase breast cancer risk in women with BRCA1 or BRCA2 mutations and intact breasts.¹⁹

Dr. Pinkerton: For this woman with early surgical menopause and hysterectomy, estrogen therapy could improve her vasomotor symptoms and decrease her risk of bone loss and GSM.¹⁷ In the Women's Health Initiative trial, there were 7 fewer breast cancers per 10,000 women-years in the estrogen-onlyarm.²⁰ Observational studies suggest that hormone therapy, when given to the average age of menopause, decreases the risks of heart disease, Parkinson disease, and dementia.²¹ Limited observational evidence suggests that hormone therapy use does not further increase risk of breast cancer in women following oophorectomy for BRCA1 or BRCA2 gene mutation.²²

The absolute risks observed with hormone therapy tended to be small, especially in younger, healthy women. Systemic hormone therapy could treat her hot flashes and her GSM symptoms and potentially decrease health risks associated with premature estrogen deficiency. Nonestrogen therapies for hot flashes include low-dose antidepressants, gabapentin, and mind-body options, such as cognitive behavioral therapy and hypnosis, but these would not decrease her health risks or treat her GSM.

If she only requests treatment of her GSM symptoms, she would be a candidate for low-dose vaginal estrogen therapy, given as a cream, tablet, or ring depending on her choice. I would not choose ospemifene as my first choice as she is having hot flashes, and there are no data yet on the drug's health benefits in early menopause. If she prefers nonestrogen vaginal therapy, the new intravaginal DHEA might be a good choice as both estrogen and testosterone are increased locally in the vagina while hormone levels remain in the postmenopausal range. There is no boxed warning on the patient insert, although safety in women with breast cancer or in those with elevated risk of breast cancer has not been tested.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Illustration: Kimberly Martens for OBG Management

Sexual function is a complex, multifaceted process mediated by neurologic functions, hormonal regulation, and psychological factors. What could possibly go wrong?

As it turns out, quite a lot. Female sexual dysfunction is a common, vastly undertreated sexual health problem that can have wide-reaching effects on a woman’s life. These effects may include impaired body image, self-confidence, and self-worth. Sexual dysfunction also can contribute to relationship dissatisfaction and leave one feeling less connected with her partner.^1,2 Studies have shown women with sexual dysfunction have higher health care expenditures³ and that depression and fatigue are common comorbidities, as is frequently seen in other chronic conditions such as diabetes and back pain.⁴

Understanding the pathogenesis of female sexual dysfunction helps to guide our approach to its management. Indeed, increased understanding of its pathology has helped to usher in new and emerging treatment options, as well as a personalized, biopsychosocial approach to its management.

Related article:
2016 Update on female sexual dysfunction

In this Update, I discuss the interplay of physiologic and psychological factors that affect female sexual function as well as the latest options for its management. I have also assembled a panel of experts to discuss 2 cases representative of sexual dysfunction that you may encounter in your clinical practice and how prescribing decisions are made for their management.

Read about factors that impact sexual function and agents to help manage dysfunction.

Multiple transmitters in the brain can increase or decrease sexual desire and function

Neurotransmitters involved in sexual excitation include brain dopamine, melanocortin, oxytocin, vasopressin, and norepinephrine, whereas brain opioids, serotonin, prolactin, and endocannabinoids function as sexual inhibitors. Inhibitory transmitters are activated normally during sexual refractoriness but also from primary aversion or secondary avoidance disorders.¹ Drugs or conditions that reduce brain dopamine levels, increase the action of brain serotonin, or enhance brain opioid pathways have been shown to inhibit sexual desire, while those that increase hypothalamic and mesolimbic dopamine or decrease serotonin release have been shown to stimulate sexual desire.¹ 

Estradiol and progesterone can impact sexual function and desire

In addition to the neurotransmitters, hormones are important modulators of female sexual function. Decreasing levels of circulating estrogen after menopause lead to physiologic, biologic, and clinical changes in the urogenital tissues, such as decreased elastin, thinning of the epithelium, reduced vaginal blood flow, diminished lubrication, and decreased flexibility and elasticity. These changes result in the symptoms of genitourinary syndrome of menopause (GSM), which affects as many as half of all menopausal women.^5,6 In clinical trials, dyspareunia and vaginal dryness are the most bothersome GSM symptoms reported.⁷

The role of hormonal regulation in sexual dysfunction among premenopausal women is not yet fully understood, but we do know that estradiol has been shown to improve sexual desire, progesterone tends to dampen sexual desire, and that testosterone at physiological levels has been shown in most studies to have a neutral effect on sexual desire in a well-estrogenized patient.⁸

Related article:
Focus on treating genital atrophy symptoms

Experience and behavior modulate or reinforce sexual dysfunction

The most common psychological factors that trigger or amplify female sexual dysfunction are depression, anxiety, distraction, negative body image, sexual abuse, and emotional neglect.⁹ Contextual or sociocultural factors, such as relationship discord, life-stage stressors (the empty nest syndrome or anxiety and sleep deprivation from a new baby), as well as cultural or religious values that suppress sexuality, also should be considered.⁹ Experience-based neuroplasticity (changes in brain pathways that become solidified by negative or positive experiences) may elucidate how a multimodal approach, utilizing medical and psychological treatment, can be beneficial for patients, particularly those with hypoactive sexual desire disorder (HSDD).¹

New and emerging approaches to managing female sexual dysfunction

Three agents, one of which has been available for prescription for some time, one that is newly available, and one in the pipeline, are or may soon be in the gynecologist's armamentarium.

Flibanserin

Medications that target excitatory pathways or blunt inhibitory pathways are in development, and one, flibanserin (Addyi), has been US Food and Drug Administration (FDA)-approved for the treatment of acquired, generalized HSDD in premenopausal women.^1,10 Flibanserin is a nonhormonal, centrally acting, postsynaptic serotonin 1A receptor agonist and a serotonin 2A receptor antagonist that is taken daily at bedtime (100 mg); several weeks are usually needed before any effects are noted.¹ It is not approved for postmenopausal women and has a boxed warning about the risks of hypotension and syncope; its use is contraindicated in women who drink alcohol, in those who have hepatic impairment, and with the use of moderate or strong CYP3A4 inhibitors.¹¹

Also keep in mind that flibanserin is only available through a Risk Evaluation and Mitigation Strategy program, so clinicians who wish to prescribe it must enroll in and complete training to become certified providers.⁹

Related article:
What you need to know (and do) to prescribe the new drug flibanserin

Prasterone

Prasterone (Intrarosa), a once-daily intravaginal dehydroepiandrosterone (DHEA) product, is a prohormone that increases local estrogen and testosterone and has the advantage of improved sexual function, desire, arousal, lubrication, orgasm, satisfaction, as well as pain at sexual activity.¹² It was approved by the FDA in November 2016 to treat moderate to severe dyspareunia and has been available for prescribing since July 2017. Its cost is comparable to topical estrogen products, with a $25 copay program.

Because prasterone is not an estrogen, it does not have the boxed warning that all estrogen products are mandated by the FDA to have. This may make it more acceptable to patients, who often decline to use an estrogen product after seeing the boxed warning on the package. The Centers for Medicare and Medicaid Services (CMS) does not have prasterone on its list of potentially hazardous drugs for the elderly. However, keep in mind that because its label is for dyspareunia and not specifically for GSM, CMS considers it a drug of choice--in other words, like sildenafil (Viagra), a lifestyle choice and not for treatment of a medical condition. As such, at the present time, Medicare does not cover it.

Bremelanotide

Late-stage trials of bremelanotide, a melanocortin receptor agonist, are underway. Its mechanism of action is somewhat like that of flibanserin in that both drugs increase dopamine and norepinephrine levels. The advantage of bremelanotide is that it is used as needed. It is dosed subcutaneously (1.75 mg) and it can be used as often as a woman would like to use it. The FDA is expected to consider it for approval in about a year. Unpublished data from poster sessions at recent meetings show that, in a phase 3 study of 1,247 premenopausal women with HSDD (who had already been screened for depression and were found to have a physiologic condition), improvements in desire, arousal, lubrication, and orgasm were shown with bremelanotide. About 18% of women stopped using the drug because of adverse effects (nausea, vomiting, flushing, or headache) versus 2% for placebo. Like flibanserin, it is expected to be approved for premenopausal women only. 

Read how 3 experts would manage differing GSM symptoms.

What would you prescribe for these patients? 

CASE Genitourinary syndrome of menopause (GSM) in a 55-year-old woman

A 55-year-old widow is beginning a new relationship. She has not had partnered sexual activity for several years, but she recently has begun a relationship. She describes pain with attempted penetration with her new partner. Her last menstrual period was 3 years ago and she has experienced very minor menopausal symptoms, which are not bothersome. On examination, the vulva and vagina are pale, with thin epithelium and absent rugae. The tissue lacks elasticity. A virginal speculum is needed to visualize the cervix.

How would you go about deciding which of the many options for management of GSM you will recommend for this patient? What do you weigh as you consider DHEA versus estrogen and topical versus oral therapy?
 
JoAnn V. Pinkerton, MD: Vulvovaginal atrophy (VVA), part of GSM, is associated with postmenopausal estrogen deficiency and includes the signs and symptoms seen on this patient's physical exam: vaginal narrowing, pallor, loss of elasticity, as well as pain with intercourse.⁶ Estrogen therapy is the most effective treatment for vaginal atrophy.¹³ Since she does not have significant menopausal symptoms, low-dose vaginal estrogen preparations are effective and generally safe treatments for VVA; these include creams, tablets containing estradiol or conjugated equine estrogen (CEE), and a low-dose vaginal estradiol ring--all available at doses that result in minimal systemic absorption.

Choice is usually made based on patient desire and likely adherence. If the patient prefers nonestrogen therapies that improve VVA and have been approved for relief of dyspareunia in postmenopausal women, I would discuss with the patient the oral selective estrogen receptor modulator ospemifene,¹⁴ and the new intravaginal DHEA suppositories, prasterone.¹⁵ Ospemifene is taken daily as an oral tablet, has a small risk of blood clots, and is my choice for women who do not need systemic hormone therapy and prefer to avoid vaginal therapy.

Andrew M. Kaunitz, MD: GSM is prevalent in menopausal women and, if not treated, causes progressive vaginal dryness and sexual discomfort. When the main indication for hormonal management in a menopausal woman is GSM (as opposed to treatment of vasomotor symptoms or prevention of osteoporosis), the treatment of choice is low-dose local vaginal estrogen, ospemifene, or prasterone (DHEA). Prasterone is a vaginally administered nonestrogen steroid that was approved by the FDA to treat dyspareunia associated with GSM. DHEA is an endogenous inactive steroid that is converted locally into androgens and estrogens; one vaginal insert is placed nightly.^16,17

This 55-year-old widow has not been sexually active for some time. The facts that attempted penetration was painful and only an ultrathin (virginal) speculum could be used for examination indicate that contraction of the pelvic floor muscles is likely present. Simply starting medical management may not lead to comfortable/successful penetrative sex for this woman. In addition to  medical management, she would likely benefit from referral for physical therapy. Using dilators and other strategies, along with the positive impact that medical management will have on the vaginal mucosa, a woman's physical therapist can work with this patient to help the pelvic floor muscles relax and facilitate comfortable penetrative sex.

James A. Simon, MD: With only minor vasomotor symptoms, I would assess the other potential benefits of a systemic therapy. These might include cardiovascular risk reduction (systemic estrogens or estrogens/progesterone in some), breast cancer risk reduction (some data suggesting ospemifene can accomplish this), osteoporosis prevention (systemic estrogens and estrogen/androgens), etc. If there is an option for a treatment to address more than one symptom, in this case GSM, assessing the risks/benefits of each of these therapies should be estimated for this specific patient.

If there are no systemic benefits to be had, then any of the local treatments should be helpful. As there are no head-to-head comparisons available, local estrogen cream, tablets, rings, local DHEA, or systemic ospemifene each should be considered possible treatments. I also feel this patient may benefit from supplementary self-dilation and/or physical therapy.

Related article:
2017 Update on menopause

 
CASE Dyspareunia and vasomotor symptoms in a 42-year-old breast cancer survivor

A 42-year-old woman with a BRCA1 mutation has undergone prophylactic mastectomies as well as hysterectomy with bilateral salpingo-oophorectomy. She reports mild to moderate hot flashes and bothersome vaginal dryness and dyspareunia. Examination confirms GSM.

Would you advise systemic hormone therapy for this patient? What would your recommendation be for management of her GSM symptoms?

Dr. Simon: While one's gut reaction would be to avoid systemic estrogen therapy in a patient with a BRCA1 mutation, the scientific information confirming this fear is lacking.¹⁸ Such patients may benefit significantly from systemic estrogen therapy (reduced risk of cardiovascular disease and cognitive decline, etc.), and with both breasts and both ovaries removed, estrogen's breast cancer risks, if any in this population, are largely avoided. The patient also may benefit from additional local therapy with either estrogens or DHEA.

Dr. Kaunitz: Due to her high lifetime risk of breast and ovarian cancer, this woman has proceeded with risk-reducing breast and gynecologic surgery. As more BRCA mutation carriers are being identified and undergo risk-reducing bilateral mastectomy (usually with reconstruction) and salpingo-oophorectomy, clinicians and mutation carriers more frequently face decisions regarding use of systemic hormone therapy.

Mutation carriers who have undergone bilateral risk-reducing mastectomy experience a very low baseline future risk for breast cancer; accordingly, concerns regarding this disease should not prevent use of systemic hormone therapy. Furthermore, without hormone replacement, induced menopause in women this age is associated with an elevated risk of osteoporosis, persistent vasomotor symptoms, cardiovascular disease, stroke, mood changes, dementia, Parkinson disease, and overall mortality. Recognizing the safety of estrogen therapy in this setting, this 42-year-old BRCA1 mutation carrier can initiate estrogen therapy. Standard dose estrogen therapy refers to oral estradiol 1.0 mg, conjugated equine estrogen 0.625 mg,or transdermal estradiol 0.05 mg. In younger women like this 42-year-old with surgically induced menopause, higher than standard replacement doses of estrogen are often appropriate.¹⁷

Due to concerns the hormone therapy might further increase future risk of breast cancer, some mutation carriers may delay or avoid risk-reducing bilateral salpingo-oophorectomy, a potentially lifesaving surgery which reduces not only future risk of ovarian cancer but also future risk for breast cancer.

Among mutation carriers with intact breasts, several studies address risk of breast cancer with use of systemic hormone therapy. Although limited in numbers of participants and years of follow-up, in aggregate, these studies provide reassurance that short-term use of systemic hormone therapy does not increase breast cancer risk in women with BRCA1 or BRCA2 mutations and intact breasts.¹⁹

Dr. Pinkerton: For this woman with early surgical menopause and hysterectomy, estrogen therapy could improve her vasomotor symptoms and decrease her risk of bone loss and GSM.¹⁷ In the Women's Health Initiative trial, there were 7 fewer breast cancers per 10,000 women-years in the estrogen-onlyarm.²⁰ Observational studies suggest that hormone therapy, when given to the average age of menopause, decreases the risks of heart disease, Parkinson disease, and dementia.²¹ Limited observational evidence suggests that hormone therapy use does not further increase risk of breast cancer in women following oophorectomy for BRCA1 or BRCA2 gene mutation.²²

The absolute risks observed with hormone therapy tended to be small, especially in younger, healthy women. Systemic hormone therapy could treat her hot flashes and her GSM symptoms and potentially decrease health risks associated with premature estrogen deficiency. Nonestrogen therapies for hot flashes include low-dose antidepressants, gabapentin, and mind-body options, such as cognitive behavioral therapy and hypnosis, but these would not decrease her health risks or treat her GSM.

If she only requests treatment of her GSM symptoms, she would be a candidate for low-dose vaginal estrogen therapy, given as a cream, tablet, or ring depending on her choice. I would not choose ospemifene as my first choice as she is having hot flashes, and there are no data yet on the drug's health benefits in early menopause. If she prefers nonestrogen vaginal therapy, the new intravaginal DHEA might be a good choice as both estrogen and testosterone are increased locally in the vagina while hormone levels remain in the postmenopausal range. There is no boxed warning on the patient insert, although safety in women with breast cancer or in those with elevated risk of breast cancer has not been tested.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Illustration: Kimberly Martens for OBG Management

Sexual function is a complex, multifaceted process mediated by neurologic functions, hormonal regulation, and psychological factors. What could possibly go wrong?

As it turns out, quite a lot. Female sexual dysfunction is a common, vastly undertreated sexual health problem that can have wide-reaching effects on a woman’s life. These effects may include impaired body image, self-confidence, and self-worth. Sexual dysfunction also can contribute to relationship dissatisfaction and leave one feeling less connected with her partner.^1,2 Studies have shown women with sexual dysfunction have higher health care expenditures³ and that depression and fatigue are common comorbidities, as is frequently seen in other chronic conditions such as diabetes and back pain.⁴

Understanding the pathogenesis of female sexual dysfunction helps to guide our approach to its management. Indeed, increased understanding of its pathology has helped to usher in new and emerging treatment options, as well as a personalized, biopsychosocial approach to its management.

Related article:
2016 Update on female sexual dysfunction

In this Update, I discuss the interplay of physiologic and psychological factors that affect female sexual function as well as the latest options for its management. I have also assembled a panel of experts to discuss 2 cases representative of sexual dysfunction that you may encounter in your clinical practice and how prescribing decisions are made for their management.

Read about factors that impact sexual function and agents to help manage dysfunction.

Multiple transmitters in the brain can increase or decrease sexual desire and function

Neurotransmitters involved in sexual excitation include brain dopamine, melanocortin, oxytocin, vasopressin, and norepinephrine, whereas brain opioids, serotonin, prolactin, and endocannabinoids function as sexual inhibitors. Inhibitory transmitters are activated normally during sexual refractoriness but also from primary aversion or secondary avoidance disorders.¹ Drugs or conditions that reduce brain dopamine levels, increase the action of brain serotonin, or enhance brain opioid pathways have been shown to inhibit sexual desire, while those that increase hypothalamic and mesolimbic dopamine or decrease serotonin release have been shown to stimulate sexual desire.¹ 

Estradiol and progesterone can impact sexual function and desire

In addition to the neurotransmitters, hormones are important modulators of female sexual function. Decreasing levels of circulating estrogen after menopause lead to physiologic, biologic, and clinical changes in the urogenital tissues, such as decreased elastin, thinning of the epithelium, reduced vaginal blood flow, diminished lubrication, and decreased flexibility and elasticity. These changes result in the symptoms of genitourinary syndrome of menopause (GSM), which affects as many as half of all menopausal women.^5,6 In clinical trials, dyspareunia and vaginal dryness are the most bothersome GSM symptoms reported.⁷

The role of hormonal regulation in sexual dysfunction among premenopausal women is not yet fully understood, but we do know that estradiol has been shown to improve sexual desire, progesterone tends to dampen sexual desire, and that testosterone at physiological levels has been shown in most studies to have a neutral effect on sexual desire in a well-estrogenized patient.⁸

Related article:
Focus on treating genital atrophy symptoms

Experience and behavior modulate or reinforce sexual dysfunction

The most common psychological factors that trigger or amplify female sexual dysfunction are depression, anxiety, distraction, negative body image, sexual abuse, and emotional neglect.⁹ Contextual or sociocultural factors, such as relationship discord, life-stage stressors (the empty nest syndrome or anxiety and sleep deprivation from a new baby), as well as cultural or religious values that suppress sexuality, also should be considered.⁹ Experience-based neuroplasticity (changes in brain pathways that become solidified by negative or positive experiences) may elucidate how a multimodal approach, utilizing medical and psychological treatment, can be beneficial for patients, particularly those with hypoactive sexual desire disorder (HSDD).¹

New and emerging approaches to managing female sexual dysfunction

Three agents, one of which has been available for prescription for some time, one that is newly available, and one in the pipeline, are or may soon be in the gynecologist's armamentarium.

Flibanserin

Medications that target excitatory pathways or blunt inhibitory pathways are in development, and one, flibanserin (Addyi), has been US Food and Drug Administration (FDA)-approved for the treatment of acquired, generalized HSDD in premenopausal women.^1,10 Flibanserin is a nonhormonal, centrally acting, postsynaptic serotonin 1A receptor agonist and a serotonin 2A receptor antagonist that is taken daily at bedtime (100 mg); several weeks are usually needed before any effects are noted.¹ It is not approved for postmenopausal women and has a boxed warning about the risks of hypotension and syncope; its use is contraindicated in women who drink alcohol, in those who have hepatic impairment, and with the use of moderate or strong CYP3A4 inhibitors.¹¹

Also keep in mind that flibanserin is only available through a Risk Evaluation and Mitigation Strategy program, so clinicians who wish to prescribe it must enroll in and complete training to become certified providers.⁹

Related article:
What you need to know (and do) to prescribe the new drug flibanserin

Prasterone

Prasterone (Intrarosa), a once-daily intravaginal dehydroepiandrosterone (DHEA) product, is a prohormone that increases local estrogen and testosterone and has the advantage of improved sexual function, desire, arousal, lubrication, orgasm, satisfaction, as well as pain at sexual activity.¹² It was approved by the FDA in November 2016 to treat moderate to severe dyspareunia and has been available for prescribing since July 2017. Its cost is comparable to topical estrogen products, with a $25 copay program.

Because prasterone is not an estrogen, it does not have the boxed warning that all estrogen products are mandated by the FDA to have. This may make it more acceptable to patients, who often decline to use an estrogen product after seeing the boxed warning on the package. The Centers for Medicare and Medicaid Services (CMS) does not have prasterone on its list of potentially hazardous drugs for the elderly. However, keep in mind that because its label is for dyspareunia and not specifically for GSM, CMS considers it a drug of choice--in other words, like sildenafil (Viagra), a lifestyle choice and not for treatment of a medical condition. As such, at the present time, Medicare does not cover it.

Bremelanotide

Late-stage trials of bremelanotide, a melanocortin receptor agonist, are underway. Its mechanism of action is somewhat like that of flibanserin in that both drugs increase dopamine and norepinephrine levels. The advantage of bremelanotide is that it is used as needed. It is dosed subcutaneously (1.75 mg) and it can be used as often as a woman would like to use it. The FDA is expected to consider it for approval in about a year. Unpublished data from poster sessions at recent meetings show that, in a phase 3 study of 1,247 premenopausal women with HSDD (who had already been screened for depression and were found to have a physiologic condition), improvements in desire, arousal, lubrication, and orgasm were shown with bremelanotide. About 18% of women stopped using the drug because of adverse effects (nausea, vomiting, flushing, or headache) versus 2% for placebo. Like flibanserin, it is expected to be approved for premenopausal women only. 

Read how 3 experts would manage differing GSM symptoms.

What would you prescribe for these patients? 

CASE Genitourinary syndrome of menopause (GSM) in a 55-year-old woman

A 55-year-old widow is beginning a new relationship. She has not had partnered sexual activity for several years, but she recently has begun a relationship. She describes pain with attempted penetration with her new partner. Her last menstrual period was 3 years ago and she has experienced very minor menopausal symptoms, which are not bothersome. On examination, the vulva and vagina are pale, with thin epithelium and absent rugae. The tissue lacks elasticity. A virginal speculum is needed to visualize the cervix.

How would you go about deciding which of the many options for management of GSM you will recommend for this patient? What do you weigh as you consider DHEA versus estrogen and topical versus oral therapy?
 
JoAnn V. Pinkerton, MD: Vulvovaginal atrophy (VVA), part of GSM, is associated with postmenopausal estrogen deficiency and includes the signs and symptoms seen on this patient's physical exam: vaginal narrowing, pallor, loss of elasticity, as well as pain with intercourse.⁶ Estrogen therapy is the most effective treatment for vaginal atrophy.¹³ Since she does not have significant menopausal symptoms, low-dose vaginal estrogen preparations are effective and generally safe treatments for VVA; these include creams, tablets containing estradiol or conjugated equine estrogen (CEE), and a low-dose vaginal estradiol ring--all available at doses that result in minimal systemic absorption.

Choice is usually made based on patient desire and likely adherence. If the patient prefers nonestrogen therapies that improve VVA and have been approved for relief of dyspareunia in postmenopausal women, I would discuss with the patient the oral selective estrogen receptor modulator ospemifene,¹⁴ and the new intravaginal DHEA suppositories, prasterone.¹⁵ Ospemifene is taken daily as an oral tablet, has a small risk of blood clots, and is my choice for women who do not need systemic hormone therapy and prefer to avoid vaginal therapy.

Andrew M. Kaunitz, MD: GSM is prevalent in menopausal women and, if not treated, causes progressive vaginal dryness and sexual discomfort. When the main indication for hormonal management in a menopausal woman is GSM (as opposed to treatment of vasomotor symptoms or prevention of osteoporosis), the treatment of choice is low-dose local vaginal estrogen, ospemifene, or prasterone (DHEA). Prasterone is a vaginally administered nonestrogen steroid that was approved by the FDA to treat dyspareunia associated with GSM. DHEA is an endogenous inactive steroid that is converted locally into androgens and estrogens; one vaginal insert is placed nightly.^16,17

This 55-year-old widow has not been sexually active for some time. The facts that attempted penetration was painful and only an ultrathin (virginal) speculum could be used for examination indicate that contraction of the pelvic floor muscles is likely present. Simply starting medical management may not lead to comfortable/successful penetrative sex for this woman. In addition to  medical management, she would likely benefit from referral for physical therapy. Using dilators and other strategies, along with the positive impact that medical management will have on the vaginal mucosa, a woman's physical therapist can work with this patient to help the pelvic floor muscles relax and facilitate comfortable penetrative sex.

James A. Simon, MD: With only minor vasomotor symptoms, I would assess the other potential benefits of a systemic therapy. These might include cardiovascular risk reduction (systemic estrogens or estrogens/progesterone in some), breast cancer risk reduction (some data suggesting ospemifene can accomplish this), osteoporosis prevention (systemic estrogens and estrogen/androgens), etc. If there is an option for a treatment to address more than one symptom, in this case GSM, assessing the risks/benefits of each of these therapies should be estimated for this specific patient.

If there are no systemic benefits to be had, then any of the local treatments should be helpful. As there are no head-to-head comparisons available, local estrogen cream, tablets, rings, local DHEA, or systemic ospemifene each should be considered possible treatments. I also feel this patient may benefit from supplementary self-dilation and/or physical therapy.

Related article:
2017 Update on menopause

 
CASE Dyspareunia and vasomotor symptoms in a 42-year-old breast cancer survivor

A 42-year-old woman with a BRCA1 mutation has undergone prophylactic mastectomies as well as hysterectomy with bilateral salpingo-oophorectomy. She reports mild to moderate hot flashes and bothersome vaginal dryness and dyspareunia. Examination confirms GSM.

Would you advise systemic hormone therapy for this patient? What would your recommendation be for management of her GSM symptoms?

Dr. Simon: While one's gut reaction would be to avoid systemic estrogen therapy in a patient with a BRCA1 mutation, the scientific information confirming this fear is lacking.¹⁸ Such patients may benefit significantly from systemic estrogen therapy (reduced risk of cardiovascular disease and cognitive decline, etc.), and with both breasts and both ovaries removed, estrogen's breast cancer risks, if any in this population, are largely avoided. The patient also may benefit from additional local therapy with either estrogens or DHEA.

Dr. Kaunitz: Due to her high lifetime risk of breast and ovarian cancer, this woman has proceeded with risk-reducing breast and gynecologic surgery. As more BRCA mutation carriers are being identified and undergo risk-reducing bilateral mastectomy (usually with reconstruction) and salpingo-oophorectomy, clinicians and mutation carriers more frequently face decisions regarding use of systemic hormone therapy.

Mutation carriers who have undergone bilateral risk-reducing mastectomy experience a very low baseline future risk for breast cancer; accordingly, concerns regarding this disease should not prevent use of systemic hormone therapy. Furthermore, without hormone replacement, induced menopause in women this age is associated with an elevated risk of osteoporosis, persistent vasomotor symptoms, cardiovascular disease, stroke, mood changes, dementia, Parkinson disease, and overall mortality. Recognizing the safety of estrogen therapy in this setting, this 42-year-old BRCA1 mutation carrier can initiate estrogen therapy. Standard dose estrogen therapy refers to oral estradiol 1.0 mg, conjugated equine estrogen 0.625 mg,or transdermal estradiol 0.05 mg. In younger women like this 42-year-old with surgically induced menopause, higher than standard replacement doses of estrogen are often appropriate.¹⁷

Due to concerns the hormone therapy might further increase future risk of breast cancer, some mutation carriers may delay or avoid risk-reducing bilateral salpingo-oophorectomy, a potentially lifesaving surgery which reduces not only future risk of ovarian cancer but also future risk for breast cancer.

Among mutation carriers with intact breasts, several studies address risk of breast cancer with use of systemic hormone therapy. Although limited in numbers of participants and years of follow-up, in aggregate, these studies provide reassurance that short-term use of systemic hormone therapy does not increase breast cancer risk in women with BRCA1 or BRCA2 mutations and intact breasts.¹⁹

Dr. Pinkerton: For this woman with early surgical menopause and hysterectomy, estrogen therapy could improve her vasomotor symptoms and decrease her risk of bone loss and GSM.¹⁷ In the Women's Health Initiative trial, there were 7 fewer breast cancers per 10,000 women-years in the estrogen-onlyarm.²⁰ Observational studies suggest that hormone therapy, when given to the average age of menopause, decreases the risks of heart disease, Parkinson disease, and dementia.²¹ Limited observational evidence suggests that hormone therapy use does not further increase risk of breast cancer in women following oophorectomy for BRCA1 or BRCA2 gene mutation.²²

The absolute risks observed with hormone therapy tended to be small, especially in younger, healthy women. Systemic hormone therapy could treat her hot flashes and her GSM symptoms and potentially decrease health risks associated with premature estrogen deficiency. Nonestrogen therapies for hot flashes include low-dose antidepressants, gabapentin, and mind-body options, such as cognitive behavioral therapy and hypnosis, but these would not decrease her health risks or treat her GSM.

If she only requests treatment of her GSM symptoms, she would be a candidate for low-dose vaginal estrogen therapy, given as a cream, tablet, or ring depending on her choice. I would not choose ospemifene as my first choice as she is having hot flashes, and there are no data yet on the drug's health benefits in early menopause. If she prefers nonestrogen vaginal therapy, the new intravaginal DHEA might be a good choice as both estrogen and testosterone are increased locally in the vagina while hormone levels remain in the postmenopausal range. There is no boxed warning on the patient insert, although safety in women with breast cancer or in those with elevated risk of breast cancer has not been tested.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

The American Society for Colposcopy and Cervical Pathology (ASCCP) has recommended HPV triage for ASC-US cytology for more than 15 years. Since the ALTS trial demonstrated improved detection of CIN2+ in women with ASC-US cytology, HPV testing has become the preferred triage strategy for women with ASC-US cytology, except for women under age 25.¹ However, we do not know the long-term outcomes for these women. The study by Cuzick and colleagues uniquely addresses this question.

Details of the study

The retrospective review of data from the New Mexico HPV Pap Registry examined the influence of HPV testing on outcomes in 20,677 women with ASC-US cytology between 2008 and 2012. Of those women, 80.5% had an HPV test, and the authors estimated that 80.6% of those HPV tests were for triage after ASC-US cytology as opposed to co-testing (that is, cytology and HPV testing together). Of note, the majority of these Pap tests were performed prior to the 2012 ASCCP guidelines that recommend HPV co-testing for all women aged 30 to 64 years regardless of cytology. Of the HPV tests performed, 43.1% were positive. The investigators then examined rates of CIN in the interval between ASC-US cytology and biopsy-confirmed CIN, and rates of loop electrosurgical excision procedures (LEEP) and results at 5 years.

The investigators found a non–statistically significant increase in overall detection of CIN3 (relative risk [RR], 1.16; 95% confidence interval [CI], 0.92–1.45) in women who had been triaged with HPV testing, and a significant increase in overall detection of CIN2 (RR, 1.27; 95% CI, 1.06–1.53) and CIN1 (RR, 1.76; 95% CI, 1.56–2.00). CIN1, CIN2, and CIN3 were detected significantly earlier in patients with HPV testing. As expected, the majority of CIN2 and CIN3 was diagnosed in women who were HPV positive.

Related article:
2017 Update on cervical disease

The proportion of women undergoing either endocervical curettage or cervical biopsy was higher in those with HPV testing (32.1% vs 20.6%, P<.001), as were LEEP rates (4.9% vs 4.0%, P = .03). LEEP rates were highest in the year after a positive HPV test and were mostly attributable to CIN1 results. However, the overall ratio of LEEP to CIN3+ diagnosis was similar in women who were tested for HPV compared with those who were not. A larger proportion of patients with HPV testing had follow-up compared with those without HPV testing (84.1% vs 78.9%, P<.001).

The authors concluded that HPV testing in women with ASC-US cytology leads to detecting high-grade disease earlier, but that HPV positivity results in more interventions, largely due to an overdiagnosis of CIN1. They also confirmed that the majority of high-grade lesions are found in women with positive HPV tests.

Related article:
2015 Update on cervical disease: New ammo for HPV prevention and screening

Study strengths and weaknesses

This is the first comprehensive long-term look at women with ASC-US cytology and the impact of HPV testing. The New Mexico HPV Pap Registry is the only US state-based registry with comprehensive follow-up data. This study’s results build on previous data that showed sensitivity is increased with the addition of HPV testing to cervical cytology,¹ and they support current ASCCP guidelines that emphasize HPV triage or co-testing for women age 25 or older.

Potential bias. While this study has the benefit of a large cohort, it is limited by biases inherent in retrospective study design. One important potential bias is the differential utilization of HPV testing or procedures by providers. The authors acknowledge preliminary analyses that show that some clinics (rural, federally qualified health centers, public health clinics) serving underserved populations may underutilize or inappropriately utilize HPV testing.

Further, the 2008–2012 study period may make the results less generalizable to current practices since the ASCCP guidelines were adjusted to include more HPV testing in women aged 25 and older in 2012.

Finally, this study examines CIN but does not specifically look at the impact of HPV testing on the ultimate outcome of interest, cervical cancer rates.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

The American Society for Colposcopy and Cervical Pathology (ASCCP) has recommended HPV triage for ASC-US cytology for more than 15 years. Since the ALTS trial demonstrated improved detection of CIN2+ in women with ASC-US cytology, HPV testing has become the preferred triage strategy for women with ASC-US cytology, except for women under age 25.¹ However, we do not know the long-term outcomes for these women. The study by Cuzick and colleagues uniquely addresses this question.

Details of the study

The retrospective review of data from the New Mexico HPV Pap Registry examined the influence of HPV testing on outcomes in 20,677 women with ASC-US cytology between 2008 and 2012. Of those women, 80.5% had an HPV test, and the authors estimated that 80.6% of those HPV tests were for triage after ASC-US cytology as opposed to co-testing (that is, cytology and HPV testing together). Of note, the majority of these Pap tests were performed prior to the 2012 ASCCP guidelines that recommend HPV co-testing for all women aged 30 to 64 years regardless of cytology. Of the HPV tests performed, 43.1% were positive. The investigators then examined rates of CIN in the interval between ASC-US cytology and biopsy-confirmed CIN, and rates of loop electrosurgical excision procedures (LEEP) and results at 5 years.

The investigators found a non–statistically significant increase in overall detection of CIN3 (relative risk [RR], 1.16; 95% confidence interval [CI], 0.92–1.45) in women who had been triaged with HPV testing, and a significant increase in overall detection of CIN2 (RR, 1.27; 95% CI, 1.06–1.53) and CIN1 (RR, 1.76; 95% CI, 1.56–2.00). CIN1, CIN2, and CIN3 were detected significantly earlier in patients with HPV testing. As expected, the majority of CIN2 and CIN3 was diagnosed in women who were HPV positive.

Related article:
2017 Update on cervical disease

The proportion of women undergoing either endocervical curettage or cervical biopsy was higher in those with HPV testing (32.1% vs 20.6%, P<.001), as were LEEP rates (4.9% vs 4.0%, P = .03). LEEP rates were highest in the year after a positive HPV test and were mostly attributable to CIN1 results. However, the overall ratio of LEEP to CIN3+ diagnosis was similar in women who were tested for HPV compared with those who were not. A larger proportion of patients with HPV testing had follow-up compared with those without HPV testing (84.1% vs 78.9%, P<.001).

The authors concluded that HPV testing in women with ASC-US cytology leads to detecting high-grade disease earlier, but that HPV positivity results in more interventions, largely due to an overdiagnosis of CIN1. They also confirmed that the majority of high-grade lesions are found in women with positive HPV tests.

Related article:
2015 Update on cervical disease: New ammo for HPV prevention and screening

Study strengths and weaknesses

This is the first comprehensive long-term look at women with ASC-US cytology and the impact of HPV testing. The New Mexico HPV Pap Registry is the only US state-based registry with comprehensive follow-up data. This study’s results build on previous data that showed sensitivity is increased with the addition of HPV testing to cervical cytology,¹ and they support current ASCCP guidelines that emphasize HPV triage or co-testing for women age 25 or older.

Potential bias. While this study has the benefit of a large cohort, it is limited by biases inherent in retrospective study design. One important potential bias is the differential utilization of HPV testing or procedures by providers. The authors acknowledge preliminary analyses that show that some clinics (rural, federally qualified health centers, public health clinics) serving underserved populations may underutilize or inappropriately utilize HPV testing.

Further, the 2008–2012 study period may make the results less generalizable to current practices since the ASCCP guidelines were adjusted to include more HPV testing in women aged 25 and older in 2012.

Finally, this study examines CIN but does not specifically look at the impact of HPV testing on the ultimate outcome of interest, cervical cancer rates.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

The American Society for Colposcopy and Cervical Pathology (ASCCP) has recommended HPV triage for ASC-US cytology for more than 15 years. Since the ALTS trial demonstrated improved detection of CIN2+ in women with ASC-US cytology, HPV testing has become the preferred triage strategy for women with ASC-US cytology, except for women under age 25.¹ However, we do not know the long-term outcomes for these women. The study by Cuzick and colleagues uniquely addresses this question.

Details of the study

The retrospective review of data from the New Mexico HPV Pap Registry examined the influence of HPV testing on outcomes in 20,677 women with ASC-US cytology between 2008 and 2012. Of those women, 80.5% had an HPV test, and the authors estimated that 80.6% of those HPV tests were for triage after ASC-US cytology as opposed to co-testing (that is, cytology and HPV testing together). Of note, the majority of these Pap tests were performed prior to the 2012 ASCCP guidelines that recommend HPV co-testing for all women aged 30 to 64 years regardless of cytology. Of the HPV tests performed, 43.1% were positive. The investigators then examined rates of CIN in the interval between ASC-US cytology and biopsy-confirmed CIN, and rates of loop electrosurgical excision procedures (LEEP) and results at 5 years.

The investigators found a non–statistically significant increase in overall detection of CIN3 (relative risk [RR], 1.16; 95% confidence interval [CI], 0.92–1.45) in women who had been triaged with HPV testing, and a significant increase in overall detection of CIN2 (RR, 1.27; 95% CI, 1.06–1.53) and CIN1 (RR, 1.76; 95% CI, 1.56–2.00). CIN1, CIN2, and CIN3 were detected significantly earlier in patients with HPV testing. As expected, the majority of CIN2 and CIN3 was diagnosed in women who were HPV positive.

Related article:
2017 Update on cervical disease

The proportion of women undergoing either endocervical curettage or cervical biopsy was higher in those with HPV testing (32.1% vs 20.6%, P<.001), as were LEEP rates (4.9% vs 4.0%, P = .03). LEEP rates were highest in the year after a positive HPV test and were mostly attributable to CIN1 results. However, the overall ratio of LEEP to CIN3+ diagnosis was similar in women who were tested for HPV compared with those who were not. A larger proportion of patients with HPV testing had follow-up compared with those without HPV testing (84.1% vs 78.9%, P<.001).

The authors concluded that HPV testing in women with ASC-US cytology leads to detecting high-grade disease earlier, but that HPV positivity results in more interventions, largely due to an overdiagnosis of CIN1. They also confirmed that the majority of high-grade lesions are found in women with positive HPV tests.

Related article:
2015 Update on cervical disease: New ammo for HPV prevention and screening

Study strengths and weaknesses

This is the first comprehensive long-term look at women with ASC-US cytology and the impact of HPV testing. The New Mexico HPV Pap Registry is the only US state-based registry with comprehensive follow-up data. This study’s results build on previous data that showed sensitivity is increased with the addition of HPV testing to cervical cytology,¹ and they support current ASCCP guidelines that emphasize HPV triage or co-testing for women age 25 or older.

Potential bias. While this study has the benefit of a large cohort, it is limited by biases inherent in retrospective study design. One important potential bias is the differential utilization of HPV testing or procedures by providers. The authors acknowledge preliminary analyses that show that some clinics (rural, federally qualified health centers, public health clinics) serving underserved populations may underutilize or inappropriately utilize HPV testing.

Further, the 2008–2012 study period may make the results less generalizable to current practices since the ASCCP guidelines were adjusted to include more HPV testing in women aged 25 and older in 2012.

Finally, this study examines CIN but does not specifically look at the impact of HPV testing on the ultimate outcome of interest, cervical cancer rates.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE A surgeon's story of patient loss

It was a Wednesday morning and Ms. M was my first case of the day. I knew her well, having delivered her 2 children. Now she had a 7-cm complex cyst on her right ovary, she was in pain, and she was possibly experiencing ovarian torsion. My resident took care of the paperwork, I met the patient in preop, answered her few questions, and reassured her husband that I would call him as soon as surgery was over. She was rolled to the operating room.

When I entered the OR, Ms. M was under general anesthesia, draped, and placed on the operating table in the usual position. I made a 5-mm incision at the umbilicus and inserted the trocar under direct visualization. There was blood and the camera became blurry. I removed the camera to clean it, and the anesthesiologist alerted me that there was sudden hypotension. I reinserted the camera and saw blood in the abdomen. I feared the worst—major vessel injury. I requested a scalpel and made a midline skin sub–umbilical incision, entered the peritoneal cavity, and observed blood everywhere. The massive transfusion protocol was activated and vascular surgery was called in. I could not find the source of the bleeding. Using a laparotomy towel I applied pressure on the aorta. The vascular surgeon arrived and pushed my resident away. He identified the source of the bleeding: The right common iliac artery was injured.

The patient coded, the anesthesiologist initiated CPR, bleeding continued, blood was being transfused, and after 20 long minutes of CPR the lifeless body of my patient could not hold any more. She was pronounced dead on the table.

At that moment, there were multiple victims: Ms. M lying on the surgical table; her family members, who did not know what was happening; and the surgical team members, who were looking at each other in denial and feeling that we had failed this patient, hoping that we would wake up from this nightmare.

Defining patient harm

Many patients experience harm each year because of an adverse medical event or preventable medical error.¹ A 2013 report revealed that 210,000 to 440,000 deaths occur each year in the United States related to preventable patient harm.² Although this fact is deeply disturbing, it is well known that modern health care is a high-risk industry.

Medical errors vary in terms of the degree of potential or actual damage. A “near miss” is any event that could have resulted in adverse consequences but did not (for example, an incorrect drug or dose ordered but not administered). On the other hand, an “adverse event” describes an error that resulted in some degree of patient harm or suffering.³

Related article:
Medical errors: Meeting ethical obligations and reducing liability with proper communication

For each patient who dies because of a medical error or a surgical complication, whether preventable or not, many clinicians are involved in the unfolding of the case. These events have a profound impact on well-intentioned, competent, and caring physicians, and they elicit intense emotional responses.⁴ When a patient experiences an unexpected adverse surgical outcome, the surgeons involved in their care may become “second victims.” They may feel that they have failed the patient and they second-guess their surgical skills and knowledge base; some express concern about their reputation and perhaps career choice.

Psychological responses. It is importantto understand this process to ensure a healthy recovery. Psychological responses to an adverse medical event include guilt; distress, anxiety, and fear; frustration and anger; feelings of insufficiency; and long-standing suffering. Clinicians who experienced an adverse medical event have reported additional psychological as well as physical symptoms in the aftermath of the event (TABLE 1).⁵

Risk factors. Certain factors are associated with a greater emotional impact of an adverse medical event, including⁶:

• severity of the harm or leaving permanent sequelae
• death of a healthy patient or a child (for example, from a motor vehicle accident)
• self-blame for the error
• unexpected patient death (for example, a catastrophic complication after a relatively benign procedure)
• physicians-in-training responsible for the patient
• first death under a clinician’s watch.

While most research in the field of medical error focuses on systems or process improvement, it is important not to neglect the individual and personal aspects of the clinicians involved in the event. The health care system must include care for our injured colleagues, the so-called second victims.

Read about the steps to recovery for the second victim.

Steps in recovery for the second victim

Based on a semistructured interview of 31 physicians involved in adverse events, Scott and colleagues described the following 6 stages of healing⁵:

Chaos and accident response. Immediately after the event, the physician feels a sense of confusion, panic, and denial. How can this be happening to me? The physician is frequently distracted, immersed in self-reflection.

Intrusive reflections. This is a period of self-questioning. Thoughts of the event and different possible scenarios dominate the physician’s mind. What if I had done this or that?

Restoring personal integrity. During this phase, the physician seeks support from individuals with whom trusted relationships exist, such as colleagues, peers, close friends, and family members. Advice from a colleague who has your same level of expertise is precious. The second victim often fears that friends and family will not be understanding.

Enduring the inquisition. Root cause analysis and in-depth case review is an important part of the quality improvement process after an adverse event. A debriefing or departmental morbidity and mortality conference can trigger emotions and increase the sense of shame, guilt, and self-doubt. The second victim starts to wonder about repercussions that may affect job security, licensure, and future litigation.

Obtaining emotional first aid. At this stage, the second victim begins to heal, but it is important to obtain external help from a colleague, mentor, counselor, department chair, or loved ones. Many physicians express concerns about not knowing who is a “safe person” to trust in this situation. Often, second victims perceive that their loved ones just do not understand their professional life or should be protected from this situation.

Moving on. There is an urge to move forward with life and simply put the event behind. This is difficult, however. A second victim may follow one of these paths:

• drop out—stop practicing clinical medicine
• survive—maintain the same career but with significant residual emotional burden from the event
• thrive—make something good out of the unfortunate clinical experience.

Related article:
TRUST: How to build a support net for ObGyns affected by a medical error

All these programs offer immediate help to any clinician in psychological distress. They provide confidentiality, and the individual is reassured that he or she can safely use the service without further consequences (TABLE 2).¹⁰

The normal human response to an adverse medical event can lead to significant psychological consequences, long-term emotional incapacity, impaired performance of clinical care, and feelings of guilt, fear, isolation, or even suicide. At some point during his or her career, almost every physician will be involved in a serious adverse medical event and is at risk of experiencing strong emotional reactions. Health care facilities should have a support system in place to help clinicians cope with these stressful circumstances.

Use these 5 strategies to facilitate recovery

1. Be determined. No matter how bad you feel about the event, you need to get up and moving.
2. Avoid isolation. Get outside and interact with people. Avoid long periods in isolation. Bring your team together and talk about the event.
3. Sleep well. Most symptoms of posttraumatic stress disorder occur at night. If you have trouble falling asleep or you wake up in the middle of the night with nightmares related to the event, attempt to regulate your body’s sleep schedule. Seek professional help if needed.
4. Avoid negative coping habits. Sometimes people turn to alcohol, cigarettes, food, or drugs to cope. Although these strategies may help in the short term, they will do more harm than good over time.
5. Enroll in activities that provide positive distraction. While the mind focuses on the traumatic event (this is normal), you need to get busy with such positive distractions as sports, going to the movies, and engaging in outdoor activities. Do things that you enjoy.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE A surgeon's story of patient loss

It was a Wednesday morning and Ms. M was my first case of the day. I knew her well, having delivered her 2 children. Now she had a 7-cm complex cyst on her right ovary, she was in pain, and she was possibly experiencing ovarian torsion. My resident took care of the paperwork, I met the patient in preop, answered her few questions, and reassured her husband that I would call him as soon as surgery was over. She was rolled to the operating room.

When I entered the OR, Ms. M was under general anesthesia, draped, and placed on the operating table in the usual position. I made a 5-mm incision at the umbilicus and inserted the trocar under direct visualization. There was blood and the camera became blurry. I removed the camera to clean it, and the anesthesiologist alerted me that there was sudden hypotension. I reinserted the camera and saw blood in the abdomen. I feared the worst—major vessel injury. I requested a scalpel and made a midline skin sub–umbilical incision, entered the peritoneal cavity, and observed blood everywhere. The massive transfusion protocol was activated and vascular surgery was called in. I could not find the source of the bleeding. Using a laparotomy towel I applied pressure on the aorta. The vascular surgeon arrived and pushed my resident away. He identified the source of the bleeding: The right common iliac artery was injured.

The patient coded, the anesthesiologist initiated CPR, bleeding continued, blood was being transfused, and after 20 long minutes of CPR the lifeless body of my patient could not hold any more. She was pronounced dead on the table.

At that moment, there were multiple victims: Ms. M lying on the surgical table; her family members, who did not know what was happening; and the surgical team members, who were looking at each other in denial and feeling that we had failed this patient, hoping that we would wake up from this nightmare.

Defining patient harm

Many patients experience harm each year because of an adverse medical event or preventable medical error.¹ A 2013 report revealed that 210,000 to 440,000 deaths occur each year in the United States related to preventable patient harm.² Although this fact is deeply disturbing, it is well known that modern health care is a high-risk industry.

Medical errors vary in terms of the degree of potential or actual damage. A “near miss” is any event that could have resulted in adverse consequences but did not (for example, an incorrect drug or dose ordered but not administered). On the other hand, an “adverse event” describes an error that resulted in some degree of patient harm or suffering.³

Related article:
Medical errors: Meeting ethical obligations and reducing liability with proper communication

For each patient who dies because of a medical error or a surgical complication, whether preventable or not, many clinicians are involved in the unfolding of the case. These events have a profound impact on well-intentioned, competent, and caring physicians, and they elicit intense emotional responses.⁴ When a patient experiences an unexpected adverse surgical outcome, the surgeons involved in their care may become “second victims.” They may feel that they have failed the patient and they second-guess their surgical skills and knowledge base; some express concern about their reputation and perhaps career choice.

Psychological responses. It is importantto understand this process to ensure a healthy recovery. Psychological responses to an adverse medical event include guilt; distress, anxiety, and fear; frustration and anger; feelings of insufficiency; and long-standing suffering. Clinicians who experienced an adverse medical event have reported additional psychological as well as physical symptoms in the aftermath of the event (TABLE 1).⁵

Risk factors. Certain factors are associated with a greater emotional impact of an adverse medical event, including⁶:

• severity of the harm or leaving permanent sequelae
• death of a healthy patient or a child (for example, from a motor vehicle accident)
• self-blame for the error
• unexpected patient death (for example, a catastrophic complication after a relatively benign procedure)
• physicians-in-training responsible for the patient
• first death under a clinician’s watch.

While most research in the field of medical error focuses on systems or process improvement, it is important not to neglect the individual and personal aspects of the clinicians involved in the event. The health care system must include care for our injured colleagues, the so-called second victims.

Read about the steps to recovery for the second victim.

Steps in recovery for the second victim

Based on a semistructured interview of 31 physicians involved in adverse events, Scott and colleagues described the following 6 stages of healing⁵:

Chaos and accident response. Immediately after the event, the physician feels a sense of confusion, panic, and denial. How can this be happening to me? The physician is frequently distracted, immersed in self-reflection.

Intrusive reflections. This is a period of self-questioning. Thoughts of the event and different possible scenarios dominate the physician’s mind. What if I had done this or that?

Restoring personal integrity. During this phase, the physician seeks support from individuals with whom trusted relationships exist, such as colleagues, peers, close friends, and family members. Advice from a colleague who has your same level of expertise is precious. The second victim often fears that friends and family will not be understanding.

Enduring the inquisition. Root cause analysis and in-depth case review is an important part of the quality improvement process after an adverse event. A debriefing or departmental morbidity and mortality conference can trigger emotions and increase the sense of shame, guilt, and self-doubt. The second victim starts to wonder about repercussions that may affect job security, licensure, and future litigation.

Obtaining emotional first aid. At this stage, the second victim begins to heal, but it is important to obtain external help from a colleague, mentor, counselor, department chair, or loved ones. Many physicians express concerns about not knowing who is a “safe person” to trust in this situation. Often, second victims perceive that their loved ones just do not understand their professional life or should be protected from this situation.

Moving on. There is an urge to move forward with life and simply put the event behind. This is difficult, however. A second victim may follow one of these paths:

• drop out—stop practicing clinical medicine
• survive—maintain the same career but with significant residual emotional burden from the event
• thrive—make something good out of the unfortunate clinical experience.

Related article:
TRUST: How to build a support net for ObGyns affected by a medical error

All these programs offer immediate help to any clinician in psychological distress. They provide confidentiality, and the individual is reassured that he or she can safely use the service without further consequences (TABLE 2).¹⁰

The normal human response to an adverse medical event can lead to significant psychological consequences, long-term emotional incapacity, impaired performance of clinical care, and feelings of guilt, fear, isolation, or even suicide. At some point during his or her career, almost every physician will be involved in a serious adverse medical event and is at risk of experiencing strong emotional reactions. Health care facilities should have a support system in place to help clinicians cope with these stressful circumstances.

Use these 5 strategies to facilitate recovery

1. Be determined. No matter how bad you feel about the event, you need to get up and moving.
2. Avoid isolation. Get outside and interact with people. Avoid long periods in isolation. Bring your team together and talk about the event.
3. Sleep well. Most symptoms of posttraumatic stress disorder occur at night. If you have trouble falling asleep or you wake up in the middle of the night with nightmares related to the event, attempt to regulate your body’s sleep schedule. Seek professional help if needed.
4. Avoid negative coping habits. Sometimes people turn to alcohol, cigarettes, food, or drugs to cope. Although these strategies may help in the short term, they will do more harm than good over time.
5. Enroll in activities that provide positive distraction. While the mind focuses on the traumatic event (this is normal), you need to get busy with such positive distractions as sports, going to the movies, and engaging in outdoor activities. Do things that you enjoy.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE A surgeon's story of patient loss

It was a Wednesday morning and Ms. M was my first case of the day. I knew her well, having delivered her 2 children. Now she had a 7-cm complex cyst on her right ovary, she was in pain, and she was possibly experiencing ovarian torsion. My resident took care of the paperwork, I met the patient in preop, answered her few questions, and reassured her husband that I would call him as soon as surgery was over. She was rolled to the operating room.

When I entered the OR, Ms. M was under general anesthesia, draped, and placed on the operating table in the usual position. I made a 5-mm incision at the umbilicus and inserted the trocar under direct visualization. There was blood and the camera became blurry. I removed the camera to clean it, and the anesthesiologist alerted me that there was sudden hypotension. I reinserted the camera and saw blood in the abdomen. I feared the worst—major vessel injury. I requested a scalpel and made a midline skin sub–umbilical incision, entered the peritoneal cavity, and observed blood everywhere. The massive transfusion protocol was activated and vascular surgery was called in. I could not find the source of the bleeding. Using a laparotomy towel I applied pressure on the aorta. The vascular surgeon arrived and pushed my resident away. He identified the source of the bleeding: The right common iliac artery was injured.

The patient coded, the anesthesiologist initiated CPR, bleeding continued, blood was being transfused, and after 20 long minutes of CPR the lifeless body of my patient could not hold any more. She was pronounced dead on the table.

At that moment, there were multiple victims: Ms. M lying on the surgical table; her family members, who did not know what was happening; and the surgical team members, who were looking at each other in denial and feeling that we had failed this patient, hoping that we would wake up from this nightmare.

Defining patient harm

Many patients experience harm each year because of an adverse medical event or preventable medical error.¹ A 2013 report revealed that 210,000 to 440,000 deaths occur each year in the United States related to preventable patient harm.² Although this fact is deeply disturbing, it is well known that modern health care is a high-risk industry.

Medical errors vary in terms of the degree of potential or actual damage. A “near miss” is any event that could have resulted in adverse consequences but did not (for example, an incorrect drug or dose ordered but not administered). On the other hand, an “adverse event” describes an error that resulted in some degree of patient harm or suffering.³

Related article:
Medical errors: Meeting ethical obligations and reducing liability with proper communication

For each patient who dies because of a medical error or a surgical complication, whether preventable or not, many clinicians are involved in the unfolding of the case. These events have a profound impact on well-intentioned, competent, and caring physicians, and they elicit intense emotional responses.⁴ When a patient experiences an unexpected adverse surgical outcome, the surgeons involved in their care may become “second victims.” They may feel that they have failed the patient and they second-guess their surgical skills and knowledge base; some express concern about their reputation and perhaps career choice.

Psychological responses. It is importantto understand this process to ensure a healthy recovery. Psychological responses to an adverse medical event include guilt; distress, anxiety, and fear; frustration and anger; feelings of insufficiency; and long-standing suffering. Clinicians who experienced an adverse medical event have reported additional psychological as well as physical symptoms in the aftermath of the event (TABLE 1).⁵

Risk factors. Certain factors are associated with a greater emotional impact of an adverse medical event, including⁶:

• severity of the harm or leaving permanent sequelae
• death of a healthy patient or a child (for example, from a motor vehicle accident)
• self-blame for the error
• unexpected patient death (for example, a catastrophic complication after a relatively benign procedure)
• physicians-in-training responsible for the patient
• first death under a clinician’s watch.

While most research in the field of medical error focuses on systems or process improvement, it is important not to neglect the individual and personal aspects of the clinicians involved in the event. The health care system must include care for our injured colleagues, the so-called second victims.

Read about the steps to recovery for the second victim.

Steps in recovery for the second victim

Based on a semistructured interview of 31 physicians involved in adverse events, Scott and colleagues described the following 6 stages of healing⁵:

Chaos and accident response. Immediately after the event, the physician feels a sense of confusion, panic, and denial. How can this be happening to me? The physician is frequently distracted, immersed in self-reflection.

Intrusive reflections. This is a period of self-questioning. Thoughts of the event and different possible scenarios dominate the physician’s mind. What if I had done this or that?

Restoring personal integrity. During this phase, the physician seeks support from individuals with whom trusted relationships exist, such as colleagues, peers, close friends, and family members. Advice from a colleague who has your same level of expertise is precious. The second victim often fears that friends and family will not be understanding.

Enduring the inquisition. Root cause analysis and in-depth case review is an important part of the quality improvement process after an adverse event. A debriefing or departmental morbidity and mortality conference can trigger emotions and increase the sense of shame, guilt, and self-doubt. The second victim starts to wonder about repercussions that may affect job security, licensure, and future litigation.

Obtaining emotional first aid. At this stage, the second victim begins to heal, but it is important to obtain external help from a colleague, mentor, counselor, department chair, or loved ones. Many physicians express concerns about not knowing who is a “safe person” to trust in this situation. Often, second victims perceive that their loved ones just do not understand their professional life or should be protected from this situation.

Moving on. There is an urge to move forward with life and simply put the event behind. This is difficult, however. A second victim may follow one of these paths:

• drop out—stop practicing clinical medicine
• survive—maintain the same career but with significant residual emotional burden from the event
• thrive—make something good out of the unfortunate clinical experience.

Related article:
TRUST: How to build a support net for ObGyns affected by a medical error

All these programs offer immediate help to any clinician in psychological distress. They provide confidentiality, and the individual is reassured that he or she can safely use the service without further consequences (TABLE 2).¹⁰

The normal human response to an adverse medical event can lead to significant psychological consequences, long-term emotional incapacity, impaired performance of clinical care, and feelings of guilt, fear, isolation, or even suicide. At some point during his or her career, almost every physician will be involved in a serious adverse medical event and is at risk of experiencing strong emotional reactions. Health care facilities should have a support system in place to help clinicians cope with these stressful circumstances.

Use these 5 strategies to facilitate recovery

1. Be determined. No matter how bad you feel about the event, you need to get up and moving.
2. Avoid isolation. Get outside and interact with people. Avoid long periods in isolation. Bring your team together and talk about the event.
3. Sleep well. Most symptoms of posttraumatic stress disorder occur at night. If you have trouble falling asleep or you wake up in the middle of the night with nightmares related to the event, attempt to regulate your body’s sleep schedule. Seek professional help if needed.
4. Avoid negative coping habits. Sometimes people turn to alcohol, cigarettes, food, or drugs to cope. Although these strategies may help in the short term, they will do more harm than good over time.
5. Enroll in activities that provide positive distraction. While the mind focuses on the traumatic event (this is normal), you need to get busy with such positive distractions as sports, going to the movies, and engaging in outdoor activities. Do things that you enjoy.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

About 3% to 4% of all fetuses at term are in breech presentation. Since 2000, when Hannah and colleagues reported finding that vaginal delivery of breech-presenting babies was riskier than cesarean delivery,¹ most breech-presenting neonates in the United States have been delivered abdominally²—despite subsequent questioning of some of that study’s conclusions.

Each year in the United States, approximately 4 million babies are born, and fetal malpresentation accounts for 110,000 to 150,000 cesarean deliveries. In fact, about 15% of all cesarean deliveries in the United States are for breech presentation or transverse lie; in England the percentage is 10%.³ Fortunately, the repopularized technique of external cephalic version (ECV), in which the clinician externally rotates a breech- or transverse-lying fetus to a vertex position (FIGURE), along with the facilitating tools of tocolysis and neuraxial analgesia/anesthesia, is helping to reduce the number of breech presentations in fetuses at term and thus the number of cesarean deliveries and their sequelae—placenta accreta, prolonged recovery, and cesarean deliveries in subsequent pregnancies.

Reluctance to perform ECV is unfounded

In the United States, the practice of offering ECV to women who present with their fetus in breech presentation at term varies tremendously. It is routine at some institutions but not even offered at others.

Many ObGyns are reluctant to perform ECV. Cited reasons include the potential for injury to the fetus and mother (and related liability concerns), the ease of elective cesarean delivery, the variable success rate of ECV (35% to 86%),⁴ and the pain that women often have with the procedure. According to the literature, however, these concerns either are unfounded or can be mitigated with use of current techniques. Multiple studies have found that the risk of ECV to the fetus and mother is minimal, and that tocolysis and neuraxial anesthesia can facilitate the success of ECV and relieve the pain associated with the procedure.

Related article:
2017 Update on obstetrics

Indications for ECV

The indications for ECV include breech, oblique, or transverse lie presentation after 36 weeks’ gestation and the mother’s desire to avoid cesarean delivery. A clinician skilled in ECV and a facility where emergency cesarean delivery is possible are essential.

There are several instances in which ECV should not be attempted.

Contraindications include:

• concerns about fetal status, including nonreactive nonstress test, biophysical profile score <6/8, severe intrauterine growth restriction, decreased end-diastolic umbilical blood flow
• placenta previa
• multifetal gestation before delivery of first twin
• severe oligohydramnios
• severe preeclampsia
• significant fetal anomaly
• known malformation of uterus
• breech with hyperextended head or arms above shoulders, as seen on ultrasonography.

More controversial contraindications include prior uterine incision, maternal obesity (body mass index >40 kg/m²), ruptured membranes, and fetal macrosomia.

Read about timing, success rates, risk factors, alternate approaches for ECV

Optimal timing for the ECV procedure

Current practice is to wait until 36 to 37 weeks to perform ECV, as most fetuses spontaneously move into vertex presentation by 36 weeks’ gestation. This time frame has several advantages: Many unnecessary attempts at ECV are avoided; only 8% of fetuses in breech presentation after 36 weeks spontaneously change to vertex⁵; many fetuses revert to breech if ECV is performed too early; and prematurity generally is not an issue in the rare case that immediate delivery is required during or just after attempted ECV.

ECV during labor. Performing ECV during labor appears to pose no increased risk to mother or fetus if membranes are intact and there are no other contraindications to the procedure. Some clinicians perform ECV only during labor. The advantages are that the fetus has had every chance to move into vertex presentation on its own, the equipment used to continuously monitor the fetus during ECV is in place, and cesarean delivery and anesthesia are immediately available in the event ECV is unsuccessful.

The major disadvantage of waiting until labor is that the increased size of the fetus makes ECV more difficult. In addition, the membranes may have already ruptured, and the breech may have descended deeply into the pelvis.

Related article:
For the management of labor, patience is a virtue

Success rates in breech-to-vertex conversions

In 2016, the American College of Obstetricians and Gynecologists (ACOG) reported an average ECV success rate of 58% (range, 16% to 100%).⁶ ACOG noted that, with transverse lie, the success rate was significantly higher. Other studies have found a wide range of rates: 58% in 1,308 patients in a Cochrane review by Hofmeyr and colleagues⁷; 47% in a study by Beuckens and colleagues⁸; and 63.1% for primiparas and 82.7% for multiparas in a study by Tong Leung and colleagues.⁹ These rates were affected by whether ECV was performed with or without tocolysis, with or without intravenous analgesia, and with or without neuraxial analgesia/anesthesia (TABLE).

Likelihood of vaginal delivery after successful ECV

The rate of vaginal delivery after successful ECV is roughly half that of fetuses that were never in breech presentation.10 In successful ECV cases, dystocia and nonreassuring fetal heart rate patterns are the major indications for cesarean delivery. Some experts have speculated that the factors leading to near-term breech presentation—such as an unengaged presenting part or a mother’s smaller pelvis—also may be risk factors for dystocia in labor. Despite this, the rate of vaginal delivery of successfully verted babies has been reported to be as high as 80%.10

Although multiple problems may occur with ECV, generally they are rare and reversible. For instance, Grootscholten and colleagues found a stillbirth and placental abruption rate of only 0.25% in a large group of patients who underwent ECV.¹¹ Similarly, the rate of emergency cesarean delivery was 0.35%. In addition, Hofmeyr and Kulier, in their Cochrane Data Review of 2015, found no significant differences in the Apgar scores and pH’s of babies in the ECV group compared with babies in breech presentation whose mothers did not undergo ECV.⁷ Results of other studies have confirmed the safety of ECV.^12,13

One significant risk of ECV attempts is fetal-to-maternal blood transfer. Boucher and colleagues found that 2.4% of 1,244 women who underwent ECV had a positive Kleihauer-Betke test result, and, in one-third of the positive cases, more than 1 mL of fetal blood was found in maternal circulation.¹⁴ This risk can be minimized by administering Rh_o (D) immune globulin to all Rh-negative mothers after the procedure.

Even these small risks, however, should not be considered in isolation. The infrequent complications of ECV must be compared with what can occur with breech-presenting fetuses during labor or cesarean delivery: complications of breech vaginal delivery, cord prolapse, difficulties with cesarean delivery, and maternal operative complications related to present and future cesarean deliveries.

Alternative approaches to converting breech presentation of unproven efficacy

Over the years, attempts have been made to address breech presentations with measures short of ECV. There is little evidence that these measures work, or work consistently.

• Observation. After 36 weeks’ gestation, only 8% of fetuses in breech presentationspontaneously move into vertex presentation.⁵
• Maternal positioning. There is no good evidence that such maneuvers are effective in changing fetal presentation.¹⁵
• Moxibustion and acupuncture. Moxibustion is inhalation of smoke from burning herbal compounds. In formal studies using controls, these techniques did not consistently increase the rate of movement from breech to vertex presentation.^16–18 Likewise, studies with the use of acupuncture have not shown consistent success in changing fetal presentation.¹⁹

Read about various methods to facilitate ECV success

Methods to facilitate ECV success

Two techniques that can facilitate ECV success are tocolysis, which relaxes the uterus, and neuraxial analgesia/anesthesia, which relaxes anterior abdominal wall muscles and reduces or relieves ECV-associated pain.

Tocolysis

In tocolysis, a medication is administered to reduce myometrial activity and to relax the uterine muscle so that it stretches more easily around the fetus during repositioning. Tocolytic medications originally were studied for their use in decreasing myometrial tone during preterm labor.

Tocolysis clearly is effective in increasing ECV success rates. Reviewing the results of 4 randomized trials, Cluver showed a 1.38 risk ratio for successful ECV when terbutaline was used versus when there was no tocolysis. The risk ratio for cesarean delivery was 0.82.²⁰ Fernandez, in a study of 103 women divided into terbutaline versus placebo groups, had a 52% success rate for ECV with the terbutaline group versus only a 27% success rate with the placebo group.²¹

Tocolytic medications include terbutaline, nifedipine, and nitroglycerin.

Tocolysis most often involves the use of β₂-adrenergic receptor agonists, particularly terbutaline (despite the boxed safety warning in its prescribing information). A 0.25-mg dose of terbutaline is given subcutaneously 15 to 30 minutes before ECV. Clinicians have successfully used β₂-adrenergic receptor agonists in the treatment of patients in preterm labor, and there are more data on this class of medications than on other agents used to facilitate ECV.

Although nifedipine is as effective as terbutaline in the temporary treatment of preterm uterine contractions, several studies have found this calcium channel blocker less effective than terbutaline in facilitating ECV.^22,23

The uterus-relaxing effect of nitroglycerin was once thought to make this medication appropriate for facilitating ECV, but multiple studies have found success rates unimproved. In some cases, the drug performed more poorly than placebo.²⁴ Moreover, nitroglycerin is associated with a fairly high rate of adverse effects, such as headaches and blood pressure changes.

Neuraxial analgesia/anesthesia

Over the past 2 decades, there has been a resurgence in the use of neuraxial analgesia/anesthesia in ECV. This technique is more effective than others in improving ECV success rates, it reduces maternal discomfort, and it is very safe. Specifically, it relaxes the maternal abdominal wall muscles and thereby facilitates ECV. Another benefit is that the anesthesia is in place and available for use should emergency cesarean delivery be needed during or after attempted ECV. Neuraxial anesthesia, which includes spinal, epidural, and combined spinal-epidural techniques, is almost always used with tocolysis.

The major complications of neuraxial analgesia/anesthesia are maternal hypotension and fetal bradycardia. Each is dose related and usually transient.

In the past, there was concern that using regional anesthesia to control pain would reduce a patient’s natural warning symptoms and result in a clinician applying excessive force, thus increasing the chances of fetal and maternal injury and even fetal death. However, multiple studies have found that ECV complication rates are not increased with use of neuraxial methods.

Higher doses of neuraxial anesthesia produce higher ECV success rates. This dose-dependent relationship is almost surely attributable to the fact that, although lower dose neuraxial analgesia can relieve the pain associated with ECV, an anesthetic dose is needed to relax the abdominal wall muscles and facilitate fetus repositioning.

The literature is clear: ECV success rates are significantly increased with the use of neuraxial techniques, with anesthesia having higher success rates than analgesia. Reviewing the results of 6 controlled trials in which a total of 508 patients underwent ECV with tocolysis, Goetzinger and colleagues found that the chance of ECV success was almost 60% higher in the 253 patients who received regional anesthesia than in the 255 patients who received intravenous or no analgesia.²⁵ Moreover, only 48.4% of the regional anesthesia patients as compared with 59.3% of patients who did not have regional anesthesia underwent cesarean delivery, roughly a 20% decrease. Pain scores were consistently lower in the regional anesthesia group. Multiple other studies have reported similar results.

Although the use of neuraxial anesthesia increases the ECV success rate, and decreases the cesarean delivery rate for breech presentation by 5% to 15%,²⁵ some groups of obstetrics professionals, noting that the decreased cesarean delivery rate does not meet the formal criterion for statistical significance, have expressed reservations about recommending regional anesthesia for ECV. Thus, despite the positive results obtained with neuraxial anesthesia, neither the literature nor authoritative professional organizations definitively recommend the use of neuraxial anesthesia in facilitating ECV.

This lack of official recommendation, however, overlooks an important point: While the cesarean delivery percentage decrease that occurs with the use of neuraxial anesthesia may not be statistically significant, the promise of a pain-free procedure will encourage more women to undergo ECV. If the procedure population increases, then the average ECV success rate of roughly 60%⁶ applies to a larger base of patients, reducing the total number of cesarean deliveries for breech presentation. As only a small percentage of the 110,000 to 150,000 women with breech presentation at 36 weeks currently elects to undergo ECV, any increase in the number of women who proceed with attempts at fetal repositioning once procedural pain is no longer an issue will accordingly reduce the number of cesarean deliveries for the indication of malpresentation.

Related article:
Nitrous oxide for labor pain

Overarching goal: Reduce cesarean delivery rate and associated risks

In the United States, increasing the use of ECV in cases of breech-presenting fetuses would reduce the cesarean delivery rate by about 10%, thereby reducing recovery time for cesarean deliveries, minimizing the risks associated with these deliveries (current and future), and providing the health care system with a major cost savings.

Tocolysis and the use of neuraxial anesthesia each increases the ECV success rate and each is remarkably safe within the context of a well-defined protocol. Reducing the pain associated with ECV by administering neuraxial anesthesia will increase the number of women electing to undergo the procedure and ultimately will reduce the number of cesarean deliveries performed for the indication of breech presentation.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

About 3% to 4% of all fetuses at term are in breech presentation. Since 2000, when Hannah and colleagues reported finding that vaginal delivery of breech-presenting babies was riskier than cesarean delivery,¹ most breech-presenting neonates in the United States have been delivered abdominally²—despite subsequent questioning of some of that study’s conclusions.

Each year in the United States, approximately 4 million babies are born, and fetal malpresentation accounts for 110,000 to 150,000 cesarean deliveries. In fact, about 15% of all cesarean deliveries in the United States are for breech presentation or transverse lie; in England the percentage is 10%.³ Fortunately, the repopularized technique of external cephalic version (ECV), in which the clinician externally rotates a breech- or transverse-lying fetus to a vertex position (FIGURE), along with the facilitating tools of tocolysis and neuraxial analgesia/anesthesia, is helping to reduce the number of breech presentations in fetuses at term and thus the number of cesarean deliveries and their sequelae—placenta accreta, prolonged recovery, and cesarean deliveries in subsequent pregnancies.

Reluctance to perform ECV is unfounded

In the United States, the practice of offering ECV to women who present with their fetus in breech presentation at term varies tremendously. It is routine at some institutions but not even offered at others.

Many ObGyns are reluctant to perform ECV. Cited reasons include the potential for injury to the fetus and mother (and related liability concerns), the ease of elective cesarean delivery, the variable success rate of ECV (35% to 86%),⁴ and the pain that women often have with the procedure. According to the literature, however, these concerns either are unfounded or can be mitigated with use of current techniques. Multiple studies have found that the risk of ECV to the fetus and mother is minimal, and that tocolysis and neuraxial anesthesia can facilitate the success of ECV and relieve the pain associated with the procedure.

Related article:
2017 Update on obstetrics

Indications for ECV

The indications for ECV include breech, oblique, or transverse lie presentation after 36 weeks’ gestation and the mother’s desire to avoid cesarean delivery. A clinician skilled in ECV and a facility where emergency cesarean delivery is possible are essential.

There are several instances in which ECV should not be attempted.

Contraindications include:

• concerns about fetal status, including nonreactive nonstress test, biophysical profile score <6/8, severe intrauterine growth restriction, decreased end-diastolic umbilical blood flow
• placenta previa
• multifetal gestation before delivery of first twin
• severe oligohydramnios
• severe preeclampsia
• significant fetal anomaly
• known malformation of uterus
• breech with hyperextended head or arms above shoulders, as seen on ultrasonography.

More controversial contraindications include prior uterine incision, maternal obesity (body mass index >40 kg/m²), ruptured membranes, and fetal macrosomia.

Read about timing, success rates, risk factors, alternate approaches for ECV

Optimal timing for the ECV procedure

Current practice is to wait until 36 to 37 weeks to perform ECV, as most fetuses spontaneously move into vertex presentation by 36 weeks’ gestation. This time frame has several advantages: Many unnecessary attempts at ECV are avoided; only 8% of fetuses in breech presentation after 36 weeks spontaneously change to vertex⁵; many fetuses revert to breech if ECV is performed too early; and prematurity generally is not an issue in the rare case that immediate delivery is required during or just after attempted ECV.

ECV during labor. Performing ECV during labor appears to pose no increased risk to mother or fetus if membranes are intact and there are no other contraindications to the procedure. Some clinicians perform ECV only during labor. The advantages are that the fetus has had every chance to move into vertex presentation on its own, the equipment used to continuously monitor the fetus during ECV is in place, and cesarean delivery and anesthesia are immediately available in the event ECV is unsuccessful.

The major disadvantage of waiting until labor is that the increased size of the fetus makes ECV more difficult. In addition, the membranes may have already ruptured, and the breech may have descended deeply into the pelvis.

Related article:
For the management of labor, patience is a virtue

Success rates in breech-to-vertex conversions

In 2016, the American College of Obstetricians and Gynecologists (ACOG) reported an average ECV success rate of 58% (range, 16% to 100%).⁶ ACOG noted that, with transverse lie, the success rate was significantly higher. Other studies have found a wide range of rates: 58% in 1,308 patients in a Cochrane review by Hofmeyr and colleagues⁷; 47% in a study by Beuckens and colleagues⁸; and 63.1% for primiparas and 82.7% for multiparas in a study by Tong Leung and colleagues.⁹ These rates were affected by whether ECV was performed with or without tocolysis, with or without intravenous analgesia, and with or without neuraxial analgesia/anesthesia (TABLE).

Likelihood of vaginal delivery after successful ECV

The rate of vaginal delivery after successful ECV is roughly half that of fetuses that were never in breech presentation.10 In successful ECV cases, dystocia and nonreassuring fetal heart rate patterns are the major indications for cesarean delivery. Some experts have speculated that the factors leading to near-term breech presentation—such as an unengaged presenting part or a mother’s smaller pelvis—also may be risk factors for dystocia in labor. Despite this, the rate of vaginal delivery of successfully verted babies has been reported to be as high as 80%.10

Although multiple problems may occur with ECV, generally they are rare and reversible. For instance, Grootscholten and colleagues found a stillbirth and placental abruption rate of only 0.25% in a large group of patients who underwent ECV.¹¹ Similarly, the rate of emergency cesarean delivery was 0.35%. In addition, Hofmeyr and Kulier, in their Cochrane Data Review of 2015, found no significant differences in the Apgar scores and pH’s of babies in the ECV group compared with babies in breech presentation whose mothers did not undergo ECV.⁷ Results of other studies have confirmed the safety of ECV.^12,13

One significant risk of ECV attempts is fetal-to-maternal blood transfer. Boucher and colleagues found that 2.4% of 1,244 women who underwent ECV had a positive Kleihauer-Betke test result, and, in one-third of the positive cases, more than 1 mL of fetal blood was found in maternal circulation.¹⁴ This risk can be minimized by administering Rh_o (D) immune globulin to all Rh-negative mothers after the procedure.

Even these small risks, however, should not be considered in isolation. The infrequent complications of ECV must be compared with what can occur with breech-presenting fetuses during labor or cesarean delivery: complications of breech vaginal delivery, cord prolapse, difficulties with cesarean delivery, and maternal operative complications related to present and future cesarean deliveries.

Alternative approaches to converting breech presentation of unproven efficacy

Over the years, attempts have been made to address breech presentations with measures short of ECV. There is little evidence that these measures work, or work consistently.

• Observation. After 36 weeks’ gestation, only 8% of fetuses in breech presentationspontaneously move into vertex presentation.⁵
• Maternal positioning. There is no good evidence that such maneuvers are effective in changing fetal presentation.¹⁵
• Moxibustion and acupuncture. Moxibustion is inhalation of smoke from burning herbal compounds. In formal studies using controls, these techniques did not consistently increase the rate of movement from breech to vertex presentation.^16–18 Likewise, studies with the use of acupuncture have not shown consistent success in changing fetal presentation.¹⁹

Read about various methods to facilitate ECV success

Methods to facilitate ECV success

Two techniques that can facilitate ECV success are tocolysis, which relaxes the uterus, and neuraxial analgesia/anesthesia, which relaxes anterior abdominal wall muscles and reduces or relieves ECV-associated pain.

Tocolysis

In tocolysis, a medication is administered to reduce myometrial activity and to relax the uterine muscle so that it stretches more easily around the fetus during repositioning. Tocolytic medications originally were studied for their use in decreasing myometrial tone during preterm labor.

Tocolysis clearly is effective in increasing ECV success rates. Reviewing the results of 4 randomized trials, Cluver showed a 1.38 risk ratio for successful ECV when terbutaline was used versus when there was no tocolysis. The risk ratio for cesarean delivery was 0.82.²⁰ Fernandez, in a study of 103 women divided into terbutaline versus placebo groups, had a 52% success rate for ECV with the terbutaline group versus only a 27% success rate with the placebo group.²¹

Tocolytic medications include terbutaline, nifedipine, and nitroglycerin.

Tocolysis most often involves the use of β₂-adrenergic receptor agonists, particularly terbutaline (despite the boxed safety warning in its prescribing information). A 0.25-mg dose of terbutaline is given subcutaneously 15 to 30 minutes before ECV. Clinicians have successfully used β₂-adrenergic receptor agonists in the treatment of patients in preterm labor, and there are more data on this class of medications than on other agents used to facilitate ECV.

Although nifedipine is as effective as terbutaline in the temporary treatment of preterm uterine contractions, several studies have found this calcium channel blocker less effective than terbutaline in facilitating ECV.^22,23

The uterus-relaxing effect of nitroglycerin was once thought to make this medication appropriate for facilitating ECV, but multiple studies have found success rates unimproved. In some cases, the drug performed more poorly than placebo.²⁴ Moreover, nitroglycerin is associated with a fairly high rate of adverse effects, such as headaches and blood pressure changes.

Neuraxial analgesia/anesthesia

Over the past 2 decades, there has been a resurgence in the use of neuraxial analgesia/anesthesia in ECV. This technique is more effective than others in improving ECV success rates, it reduces maternal discomfort, and it is very safe. Specifically, it relaxes the maternal abdominal wall muscles and thereby facilitates ECV. Another benefit is that the anesthesia is in place and available for use should emergency cesarean delivery be needed during or after attempted ECV. Neuraxial anesthesia, which includes spinal, epidural, and combined spinal-epidural techniques, is almost always used with tocolysis.

The major complications of neuraxial analgesia/anesthesia are maternal hypotension and fetal bradycardia. Each is dose related and usually transient.

In the past, there was concern that using regional anesthesia to control pain would reduce a patient’s natural warning symptoms and result in a clinician applying excessive force, thus increasing the chances of fetal and maternal injury and even fetal death. However, multiple studies have found that ECV complication rates are not increased with use of neuraxial methods.

Higher doses of neuraxial anesthesia produce higher ECV success rates. This dose-dependent relationship is almost surely attributable to the fact that, although lower dose neuraxial analgesia can relieve the pain associated with ECV, an anesthetic dose is needed to relax the abdominal wall muscles and facilitate fetus repositioning.

The literature is clear: ECV success rates are significantly increased with the use of neuraxial techniques, with anesthesia having higher success rates than analgesia. Reviewing the results of 6 controlled trials in which a total of 508 patients underwent ECV with tocolysis, Goetzinger and colleagues found that the chance of ECV success was almost 60% higher in the 253 patients who received regional anesthesia than in the 255 patients who received intravenous or no analgesia.²⁵ Moreover, only 48.4% of the regional anesthesia patients as compared with 59.3% of patients who did not have regional anesthesia underwent cesarean delivery, roughly a 20% decrease. Pain scores were consistently lower in the regional anesthesia group. Multiple other studies have reported similar results.

Although the use of neuraxial anesthesia increases the ECV success rate, and decreases the cesarean delivery rate for breech presentation by 5% to 15%,²⁵ some groups of obstetrics professionals, noting that the decreased cesarean delivery rate does not meet the formal criterion for statistical significance, have expressed reservations about recommending regional anesthesia for ECV. Thus, despite the positive results obtained with neuraxial anesthesia, neither the literature nor authoritative professional organizations definitively recommend the use of neuraxial anesthesia in facilitating ECV.

This lack of official recommendation, however, overlooks an important point: While the cesarean delivery percentage decrease that occurs with the use of neuraxial anesthesia may not be statistically significant, the promise of a pain-free procedure will encourage more women to undergo ECV. If the procedure population increases, then the average ECV success rate of roughly 60%⁶ applies to a larger base of patients, reducing the total number of cesarean deliveries for breech presentation. As only a small percentage of the 110,000 to 150,000 women with breech presentation at 36 weeks currently elects to undergo ECV, any increase in the number of women who proceed with attempts at fetal repositioning once procedural pain is no longer an issue will accordingly reduce the number of cesarean deliveries for the indication of malpresentation.

Related article:
Nitrous oxide for labor pain

Overarching goal: Reduce cesarean delivery rate and associated risks

In the United States, increasing the use of ECV in cases of breech-presenting fetuses would reduce the cesarean delivery rate by about 10%, thereby reducing recovery time for cesarean deliveries, minimizing the risks associated with these deliveries (current and future), and providing the health care system with a major cost savings.

Tocolysis and the use of neuraxial anesthesia each increases the ECV success rate and each is remarkably safe within the context of a well-defined protocol. Reducing the pain associated with ECV by administering neuraxial anesthesia will increase the number of women electing to undergo the procedure and ultimately will reduce the number of cesarean deliveries performed for the indication of breech presentation.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

About 3% to 4% of all fetuses at term are in breech presentation. Since 2000, when Hannah and colleagues reported finding that vaginal delivery of breech-presenting babies was riskier than cesarean delivery,¹ most breech-presenting neonates in the United States have been delivered abdominally²—despite subsequent questioning of some of that study’s conclusions.

Each year in the United States, approximately 4 million babies are born, and fetal malpresentation accounts for 110,000 to 150,000 cesarean deliveries. In fact, about 15% of all cesarean deliveries in the United States are for breech presentation or transverse lie; in England the percentage is 10%.³ Fortunately, the repopularized technique of external cephalic version (ECV), in which the clinician externally rotates a breech- or transverse-lying fetus to a vertex position (FIGURE), along with the facilitating tools of tocolysis and neuraxial analgesia/anesthesia, is helping to reduce the number of breech presentations in fetuses at term and thus the number of cesarean deliveries and their sequelae—placenta accreta, prolonged recovery, and cesarean deliveries in subsequent pregnancies.

Reluctance to perform ECV is unfounded

In the United States, the practice of offering ECV to women who present with their fetus in breech presentation at term varies tremendously. It is routine at some institutions but not even offered at others.

Many ObGyns are reluctant to perform ECV. Cited reasons include the potential for injury to the fetus and mother (and related liability concerns), the ease of elective cesarean delivery, the variable success rate of ECV (35% to 86%),⁴ and the pain that women often have with the procedure. According to the literature, however, these concerns either are unfounded or can be mitigated with use of current techniques. Multiple studies have found that the risk of ECV to the fetus and mother is minimal, and that tocolysis and neuraxial anesthesia can facilitate the success of ECV and relieve the pain associated with the procedure.

Related article:
2017 Update on obstetrics

Indications for ECV

The indications for ECV include breech, oblique, or transverse lie presentation after 36 weeks’ gestation and the mother’s desire to avoid cesarean delivery. A clinician skilled in ECV and a facility where emergency cesarean delivery is possible are essential.

There are several instances in which ECV should not be attempted.

Contraindications include:

• concerns about fetal status, including nonreactive nonstress test, biophysical profile score <6/8, severe intrauterine growth restriction, decreased end-diastolic umbilical blood flow
• placenta previa
• multifetal gestation before delivery of first twin
• severe oligohydramnios
• severe preeclampsia
• significant fetal anomaly
• known malformation of uterus
• breech with hyperextended head or arms above shoulders, as seen on ultrasonography.

More controversial contraindications include prior uterine incision, maternal obesity (body mass index >40 kg/m²), ruptured membranes, and fetal macrosomia.

Read about timing, success rates, risk factors, alternate approaches for ECV

Optimal timing for the ECV procedure

Current practice is to wait until 36 to 37 weeks to perform ECV, as most fetuses spontaneously move into vertex presentation by 36 weeks’ gestation. This time frame has several advantages: Many unnecessary attempts at ECV are avoided; only 8% of fetuses in breech presentation after 36 weeks spontaneously change to vertex⁵; many fetuses revert to breech if ECV is performed too early; and prematurity generally is not an issue in the rare case that immediate delivery is required during or just after attempted ECV.

ECV during labor. Performing ECV during labor appears to pose no increased risk to mother or fetus if membranes are intact and there are no other contraindications to the procedure. Some clinicians perform ECV only during labor. The advantages are that the fetus has had every chance to move into vertex presentation on its own, the equipment used to continuously monitor the fetus during ECV is in place, and cesarean delivery and anesthesia are immediately available in the event ECV is unsuccessful.

The major disadvantage of waiting until labor is that the increased size of the fetus makes ECV more difficult. In addition, the membranes may have already ruptured, and the breech may have descended deeply into the pelvis.

Related article:
For the management of labor, patience is a virtue

Success rates in breech-to-vertex conversions

In 2016, the American College of Obstetricians and Gynecologists (ACOG) reported an average ECV success rate of 58% (range, 16% to 100%).⁶ ACOG noted that, with transverse lie, the success rate was significantly higher. Other studies have found a wide range of rates: 58% in 1,308 patients in a Cochrane review by Hofmeyr and colleagues⁷; 47% in a study by Beuckens and colleagues⁸; and 63.1% for primiparas and 82.7% for multiparas in a study by Tong Leung and colleagues.⁹ These rates were affected by whether ECV was performed with or without tocolysis, with or without intravenous analgesia, and with or without neuraxial analgesia/anesthesia (TABLE).

Likelihood of vaginal delivery after successful ECV

The rate of vaginal delivery after successful ECV is roughly half that of fetuses that were never in breech presentation.10 In successful ECV cases, dystocia and nonreassuring fetal heart rate patterns are the major indications for cesarean delivery. Some experts have speculated that the factors leading to near-term breech presentation—such as an unengaged presenting part or a mother’s smaller pelvis—also may be risk factors for dystocia in labor. Despite this, the rate of vaginal delivery of successfully verted babies has been reported to be as high as 80%.10

Although multiple problems may occur with ECV, generally they are rare and reversible. For instance, Grootscholten and colleagues found a stillbirth and placental abruption rate of only 0.25% in a large group of patients who underwent ECV.¹¹ Similarly, the rate of emergency cesarean delivery was 0.35%. In addition, Hofmeyr and Kulier, in their Cochrane Data Review of 2015, found no significant differences in the Apgar scores and pH’s of babies in the ECV group compared with babies in breech presentation whose mothers did not undergo ECV.⁷ Results of other studies have confirmed the safety of ECV.^12,13

One significant risk of ECV attempts is fetal-to-maternal blood transfer. Boucher and colleagues found that 2.4% of 1,244 women who underwent ECV had a positive Kleihauer-Betke test result, and, in one-third of the positive cases, more than 1 mL of fetal blood was found in maternal circulation.¹⁴ This risk can be minimized by administering Rh_o (D) immune globulin to all Rh-negative mothers after the procedure.

Even these small risks, however, should not be considered in isolation. The infrequent complications of ECV must be compared with what can occur with breech-presenting fetuses during labor or cesarean delivery: complications of breech vaginal delivery, cord prolapse, difficulties with cesarean delivery, and maternal operative complications related to present and future cesarean deliveries.

Alternative approaches to converting breech presentation of unproven efficacy

Over the years, attempts have been made to address breech presentations with measures short of ECV. There is little evidence that these measures work, or work consistently.

• Observation. After 36 weeks’ gestation, only 8% of fetuses in breech presentationspontaneously move into vertex presentation.⁵
• Maternal positioning. There is no good evidence that such maneuvers are effective in changing fetal presentation.¹⁵
• Moxibustion and acupuncture. Moxibustion is inhalation of smoke from burning herbal compounds. In formal studies using controls, these techniques did not consistently increase the rate of movement from breech to vertex presentation.^16–18 Likewise, studies with the use of acupuncture have not shown consistent success in changing fetal presentation.¹⁹

Read about various methods to facilitate ECV success

Methods to facilitate ECV success

Two techniques that can facilitate ECV success are tocolysis, which relaxes the uterus, and neuraxial analgesia/anesthesia, which relaxes anterior abdominal wall muscles and reduces or relieves ECV-associated pain.

Tocolysis

In tocolysis, a medication is administered to reduce myometrial activity and to relax the uterine muscle so that it stretches more easily around the fetus during repositioning. Tocolytic medications originally were studied for their use in decreasing myometrial tone during preterm labor.

Tocolysis clearly is effective in increasing ECV success rates. Reviewing the results of 4 randomized trials, Cluver showed a 1.38 risk ratio for successful ECV when terbutaline was used versus when there was no tocolysis. The risk ratio for cesarean delivery was 0.82.²⁰ Fernandez, in a study of 103 women divided into terbutaline versus placebo groups, had a 52% success rate for ECV with the terbutaline group versus only a 27% success rate with the placebo group.²¹

Tocolytic medications include terbutaline, nifedipine, and nitroglycerin.

Tocolysis most often involves the use of β₂-adrenergic receptor agonists, particularly terbutaline (despite the boxed safety warning in its prescribing information). A 0.25-mg dose of terbutaline is given subcutaneously 15 to 30 minutes before ECV. Clinicians have successfully used β₂-adrenergic receptor agonists in the treatment of patients in preterm labor, and there are more data on this class of medications than on other agents used to facilitate ECV.

Although nifedipine is as effective as terbutaline in the temporary treatment of preterm uterine contractions, several studies have found this calcium channel blocker less effective than terbutaline in facilitating ECV.^22,23

The uterus-relaxing effect of nitroglycerin was once thought to make this medication appropriate for facilitating ECV, but multiple studies have found success rates unimproved. In some cases, the drug performed more poorly than placebo.²⁴ Moreover, nitroglycerin is associated with a fairly high rate of adverse effects, such as headaches and blood pressure changes.

Neuraxial analgesia/anesthesia

Over the past 2 decades, there has been a resurgence in the use of neuraxial analgesia/anesthesia in ECV. This technique is more effective than others in improving ECV success rates, it reduces maternal discomfort, and it is very safe. Specifically, it relaxes the maternal abdominal wall muscles and thereby facilitates ECV. Another benefit is that the anesthesia is in place and available for use should emergency cesarean delivery be needed during or after attempted ECV. Neuraxial anesthesia, which includes spinal, epidural, and combined spinal-epidural techniques, is almost always used with tocolysis.

The major complications of neuraxial analgesia/anesthesia are maternal hypotension and fetal bradycardia. Each is dose related and usually transient.

In the past, there was concern that using regional anesthesia to control pain would reduce a patient’s natural warning symptoms and result in a clinician applying excessive force, thus increasing the chances of fetal and maternal injury and even fetal death. However, multiple studies have found that ECV complication rates are not increased with use of neuraxial methods.

Higher doses of neuraxial anesthesia produce higher ECV success rates. This dose-dependent relationship is almost surely attributable to the fact that, although lower dose neuraxial analgesia can relieve the pain associated with ECV, an anesthetic dose is needed to relax the abdominal wall muscles and facilitate fetus repositioning.

The literature is clear: ECV success rates are significantly increased with the use of neuraxial techniques, with anesthesia having higher success rates than analgesia. Reviewing the results of 6 controlled trials in which a total of 508 patients underwent ECV with tocolysis, Goetzinger and colleagues found that the chance of ECV success was almost 60% higher in the 253 patients who received regional anesthesia than in the 255 patients who received intravenous or no analgesia.²⁵ Moreover, only 48.4% of the regional anesthesia patients as compared with 59.3% of patients who did not have regional anesthesia underwent cesarean delivery, roughly a 20% decrease. Pain scores were consistently lower in the regional anesthesia group. Multiple other studies have reported similar results.

Although the use of neuraxial anesthesia increases the ECV success rate, and decreases the cesarean delivery rate for breech presentation by 5% to 15%,²⁵ some groups of obstetrics professionals, noting that the decreased cesarean delivery rate does not meet the formal criterion for statistical significance, have expressed reservations about recommending regional anesthesia for ECV. Thus, despite the positive results obtained with neuraxial anesthesia, neither the literature nor authoritative professional organizations definitively recommend the use of neuraxial anesthesia in facilitating ECV.

This lack of official recommendation, however, overlooks an important point: While the cesarean delivery percentage decrease that occurs with the use of neuraxial anesthesia may not be statistically significant, the promise of a pain-free procedure will encourage more women to undergo ECV. If the procedure population increases, then the average ECV success rate of roughly 60%⁶ applies to a larger base of patients, reducing the total number of cesarean deliveries for breech presentation. As only a small percentage of the 110,000 to 150,000 women with breech presentation at 36 weeks currently elects to undergo ECV, any increase in the number of women who proceed with attempts at fetal repositioning once procedural pain is no longer an issue will accordingly reduce the number of cesarean deliveries for the indication of malpresentation.

Related article:
Nitrous oxide for labor pain

Overarching goal: Reduce cesarean delivery rate and associated risks

In the United States, increasing the use of ECV in cases of breech-presenting fetuses would reduce the cesarean delivery rate by about 10%, thereby reducing recovery time for cesarean deliveries, minimizing the risks associated with these deliveries (current and future), and providing the health care system with a major cost savings.

Tocolysis and the use of neuraxial anesthesia each increases the ECV success rate and each is remarkably safe within the context of a well-defined protocol. Reducing the pain associated with ECV by administering neuraxial anesthesia will increase the number of women electing to undergo the procedure and ultimately will reduce the number of cesarean deliveries performed for the indication of breech presentation.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Developing an effective social media marketing campaign can expand your practice to bring you more of the type of patient you want to treat. Although ObGyns are often not trained in marketing, we can bring our practices to the attention of women who need our services with a few simple processes.

The American Marketing Association defines marketing as “the activity, set of institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large.”¹ Social media is described as various forms of online and mobile electronic communication with user-generated content.² Social media marketing is the application of traditional marketing strategies to a social media platform. Delivering an effective social media marketing campaign requires focused targeting of a particular community to match the needs of those patients with the value of services and products your practice provides.

By communicating and connecting with the spoken and unspoken needs and desires of potential patients, you will generate greater enthusiasm for your medical services. Social media marketing benefits include: accessibility, low cost, the ability to build brand recognition and social capital, and the availability of analytics that provide large amounts of data to measure the effectiveness of the campaign.³

Though social media is pervasive, the medical community has not rapidly embraced it for marketing.^4,5 Creating a social media strategy, rather than randomly or impulsively posting on social media, allows for more effective marketing. The discussion here focuses on Facebook, which has 2 billion monthly users,⁶ but these strategies and tactics can be applied to any social media platform, including YouTube, Instagram, and Twitter.⁷

Use Facebook to create a business page

Your medical practice needs to have a Facebook account and a Facebook page, separate from your personal account. A business-related Facebook page is similar to a personal Facebook profile except that pages are designed for organizations, brands, businesses, and public figures to share photos, stories, and events with the public.

If you do not have a Facebook account, you can create a new account and profile at http://www.facebook.com. After creating a profile, click on the “create a Facebook page” link. Follow the instructions and select the page category you would like to create; most physicians would select the “Company,” “Organization,” or “Institution” category. Next, follow the instructions to complete the registration.⁸ Once your Facebook page is created, build an audience asking others to “like” your page. Start posting content and use hashtags in your posts to make them discoverable to others (ie, #fibroids #noscar #singlesitesurgery).⁹

Related article:
Using the Internet in your practice. Part 2: Generating new patients using social media

One benefit to having a practice-based Facebook page is the automated visible analytics that come with the page, which are not available for personal profiles. When you write a post or upload a photo or video, Facebook provides the demographics of those engaged with your posts plus analytics on that post, including the number of people who viewed the post, clicked on a photo, and viewed the video for more than 3 seconds.

Read how to get patients interested in your practice

Develop a social media marketing strategy

There are several key factors to consider when planning a strategy. First, know the mission of your organization and the specific service, value, or benefit you would like to provide to the targeted community.⁸

Segment, target, and position (STP)

It is tempting to try to reach out to all women because your ObGyn practice entails pre‑natal care, family planning, and gynecologic surgery, but by narrowing your target audience, your campaign will be better focused. A very specific target audience can reduce the costs for “boosting” (paid promotion of your posts on Facebook to a chosen audience based on demographics, interests, and behaviors) your posts and improve your return on investment (ROI).

Create different marketing campaigns, but focus on one at a time. Decide on the ideal patient you want to serve in your practice. The more detailed and focused you are about the demographics and type of medical needs to be served, the better you can target this patient.¹⁰

Segment. Divide the communities you are considering into different segments. For instance, even though you may do obstetrics and gynecologic surgery, consider breaking up the campaign to focus on 1 specific group, such as those interested in fibroid management.

Target. Identify the kinds of communities where you might find this patient. For example, if you want to focus on laparoscopic hysterectomies or myomectomies, start looking on Facebook for groups, pages, or website discussion boards or blogs that discuss abnormal uterine bleeding or fibroids and follow those pages.

Also, think about what other characteristics are associated with these ideal patients. For example, you might narrow it down to perimenopausal women with fibroids. A potential targeted group could be 40- to 50-year-old women who participate in yoga or running who have concerns about fibroids interfering in their active lifestyle. Perhaps this type of patient would want a minimally invasive surgical approach. A holistic health activist might be interested in nonsurgical management of fibroids.

Position. Once you have identified the specific community to target, position your practice within the community with the value proposition you are offering. For example, as an ObGyn who is focused on surgery, your position might be that your practice will provide the best experience for those medical services, with specific counseling to patients about resuming their active lifestyle.

Related article:
Four pillars of a successful practice: 2. Attract new patients

Get your potential patient to “raise her hand.” In the campaign, you are not trying to convince everyone up front to schedule an appointment from one post. First, try to get people who may be interested in your service(s) to “raise their hands.” Once your target market has expressed interest, either by their likes of your post, likes of your page, or other engagement, reach out to them with links for more information, such as free fibroid surgery education materials located on your website. On your website, create an opt-in page asking them to register their email address; once you have a compiled email list, send out monthly newsletters on your practice.¹¹

Read how to guide patients to your office

Understand that marketing is a process

Think of marketing as an overall process in which you are guiding potential patients to come to your office. Your campaign has several steps; recognize that just one post will not make a huge difference. Use Facebook analytics to measure cost per engagement to calculate your return on investment and the campaign’s effectiveness, and revise as necessary.

Rather than just considering social media as a soap box to advertise your practice, break up the marketing process into 3 units: the before unit, the during unit, and the after unit.¹¹ The word “unit” denotes the service, benefit, or product you are providing.

The before unit refers to the initial marketing that identifies potential patients—initially getting them to raise their hands and ultimately building an audience. (Once a potential patient provides her email address, you can send her a monthly newsletter or updates about your practice to continue the engagement.) Statistics show that an ObGyn needs to have 7 contacts, on average, with a patient over 18 months to “penetrate” her consciousness in a given market.¹² Of course if there is an urgent or emergent need to see a physician, that timeline would be much shorter.

The during unit occurs when the patient comes to your practice and service is being provided. Since you know what she is coming for, you can create informational packets focused on her particular needs, perhaps about different management options for fibroids.

The after unit includes following up with the patient in some automated way. For those being treated for fibroids, it may be a reminder email that discusses the value of follow-up ultrasonography or the various kinds of surgical interventions for fibroids.

In order to continue your campaign, it is helpful to have a designated social media manager who will continue the social media posts and engagement.

When creating the posts, consider developing prescheduled assets (posts that are already produced with photos or links to articles), which can be done through Facebook or Hootsuite (http://www.hootsuite.com).

Manage the risks of social media interaction

There are risks associated with social media. Some things to consider are:

• Policy. Develop a policy for your practice; if you work for an institution, align your policy with the institution’s.
• Postings. Supervise content being posted. Never allow social media to be placed by someone without supervision. Either you should do this or assign a manager to be accountable to check on social media interactions so that any inappropriate comments can be addressed immediately.
• Privacy. Never mention patients’ private health information or use the platform to publicly engage with a patient or future patient about their care. Do not post any references to patients or their photos without written consent.
• Images. Use photographs and other images properly: obtain releases and obey copyright laws.

Related article:
Your patients are talking: Isn’t it time you take responsibility for your online reputation?

Bottom line

Social media is a powerful platform. Combined with good marketing strategies, social media campaigns can have a significant impact on expanding your practice to offer the kind of medical services you want to provide.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Developing an effective social media marketing campaign can expand your practice to bring you more of the type of patient you want to treat. Although ObGyns are often not trained in marketing, we can bring our practices to the attention of women who need our services with a few simple processes.

The American Marketing Association defines marketing as “the activity, set of institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large.”¹ Social media is described as various forms of online and mobile electronic communication with user-generated content.² Social media marketing is the application of traditional marketing strategies to a social media platform. Delivering an effective social media marketing campaign requires focused targeting of a particular community to match the needs of those patients with the value of services and products your practice provides.

By communicating and connecting with the spoken and unspoken needs and desires of potential patients, you will generate greater enthusiasm for your medical services. Social media marketing benefits include: accessibility, low cost, the ability to build brand recognition and social capital, and the availability of analytics that provide large amounts of data to measure the effectiveness of the campaign.³

Though social media is pervasive, the medical community has not rapidly embraced it for marketing.^4,5 Creating a social media strategy, rather than randomly or impulsively posting on social media, allows for more effective marketing. The discussion here focuses on Facebook, which has 2 billion monthly users,⁶ but these strategies and tactics can be applied to any social media platform, including YouTube, Instagram, and Twitter.⁷

Use Facebook to create a business page

Your medical practice needs to have a Facebook account and a Facebook page, separate from your personal account. A business-related Facebook page is similar to a personal Facebook profile except that pages are designed for organizations, brands, businesses, and public figures to share photos, stories, and events with the public.

If you do not have a Facebook account, you can create a new account and profile at http://www.facebook.com. After creating a profile, click on the “create a Facebook page” link. Follow the instructions and select the page category you would like to create; most physicians would select the “Company,” “Organization,” or “Institution” category. Next, follow the instructions to complete the registration.⁸ Once your Facebook page is created, build an audience asking others to “like” your page. Start posting content and use hashtags in your posts to make them discoverable to others (ie, #fibroids #noscar #singlesitesurgery).⁹

Related article:
Using the Internet in your practice. Part 2: Generating new patients using social media

One benefit to having a practice-based Facebook page is the automated visible analytics that come with the page, which are not available for personal profiles. When you write a post or upload a photo or video, Facebook provides the demographics of those engaged with your posts plus analytics on that post, including the number of people who viewed the post, clicked on a photo, and viewed the video for more than 3 seconds.

Read how to get patients interested in your practice

Develop a social media marketing strategy

There are several key factors to consider when planning a strategy. First, know the mission of your organization and the specific service, value, or benefit you would like to provide to the targeted community.⁸

Segment, target, and position (STP)

It is tempting to try to reach out to all women because your ObGyn practice entails pre‑natal care, family planning, and gynecologic surgery, but by narrowing your target audience, your campaign will be better focused. A very specific target audience can reduce the costs for “boosting” (paid promotion of your posts on Facebook to a chosen audience based on demographics, interests, and behaviors) your posts and improve your return on investment (ROI).

Create different marketing campaigns, but focus on one at a time. Decide on the ideal patient you want to serve in your practice. The more detailed and focused you are about the demographics and type of medical needs to be served, the better you can target this patient.¹⁰

Segment. Divide the communities you are considering into different segments. For instance, even though you may do obstetrics and gynecologic surgery, consider breaking up the campaign to focus on 1 specific group, such as those interested in fibroid management.

Target. Identify the kinds of communities where you might find this patient. For example, if you want to focus on laparoscopic hysterectomies or myomectomies, start looking on Facebook for groups, pages, or website discussion boards or blogs that discuss abnormal uterine bleeding or fibroids and follow those pages.

Also, think about what other characteristics are associated with these ideal patients. For example, you might narrow it down to perimenopausal women with fibroids. A potential targeted group could be 40- to 50-year-old women who participate in yoga or running who have concerns about fibroids interfering in their active lifestyle. Perhaps this type of patient would want a minimally invasive surgical approach. A holistic health activist might be interested in nonsurgical management of fibroids.

Position. Once you have identified the specific community to target, position your practice within the community with the value proposition you are offering. For example, as an ObGyn who is focused on surgery, your position might be that your practice will provide the best experience for those medical services, with specific counseling to patients about resuming their active lifestyle.

Related article:
Four pillars of a successful practice: 2. Attract new patients

Get your potential patient to “raise her hand.” In the campaign, you are not trying to convince everyone up front to schedule an appointment from one post. First, try to get people who may be interested in your service(s) to “raise their hands.” Once your target market has expressed interest, either by their likes of your post, likes of your page, or other engagement, reach out to them with links for more information, such as free fibroid surgery education materials located on your website. On your website, create an opt-in page asking them to register their email address; once you have a compiled email list, send out monthly newsletters on your practice.¹¹

Read how to guide patients to your office

Understand that marketing is a process

Think of marketing as an overall process in which you are guiding potential patients to come to your office. Your campaign has several steps; recognize that just one post will not make a huge difference. Use Facebook analytics to measure cost per engagement to calculate your return on investment and the campaign’s effectiveness, and revise as necessary.

Rather than just considering social media as a soap box to advertise your practice, break up the marketing process into 3 units: the before unit, the during unit, and the after unit.¹¹ The word “unit” denotes the service, benefit, or product you are providing.

The before unit refers to the initial marketing that identifies potential patients—initially getting them to raise their hands and ultimately building an audience. (Once a potential patient provides her email address, you can send her a monthly newsletter or updates about your practice to continue the engagement.) Statistics show that an ObGyn needs to have 7 contacts, on average, with a patient over 18 months to “penetrate” her consciousness in a given market.¹² Of course if there is an urgent or emergent need to see a physician, that timeline would be much shorter.

The during unit occurs when the patient comes to your practice and service is being provided. Since you know what she is coming for, you can create informational packets focused on her particular needs, perhaps about different management options for fibroids.

The after unit includes following up with the patient in some automated way. For those being treated for fibroids, it may be a reminder email that discusses the value of follow-up ultrasonography or the various kinds of surgical interventions for fibroids.

In order to continue your campaign, it is helpful to have a designated social media manager who will continue the social media posts and engagement.

When creating the posts, consider developing prescheduled assets (posts that are already produced with photos or links to articles), which can be done through Facebook or Hootsuite (http://www.hootsuite.com).

Manage the risks of social media interaction

There are risks associated with social media. Some things to consider are:

• Policy. Develop a policy for your practice; if you work for an institution, align your policy with the institution’s.
• Postings. Supervise content being posted. Never allow social media to be placed by someone without supervision. Either you should do this or assign a manager to be accountable to check on social media interactions so that any inappropriate comments can be addressed immediately.
• Privacy. Never mention patients’ private health information or use the platform to publicly engage with a patient or future patient about their care. Do not post any references to patients or their photos without written consent.
• Images. Use photographs and other images properly: obtain releases and obey copyright laws.

Related article:
Your patients are talking: Isn’t it time you take responsibility for your online reputation?

Bottom line

Social media is a powerful platform. Combined with good marketing strategies, social media campaigns can have a significant impact on expanding your practice to offer the kind of medical services you want to provide.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Developing an effective social media marketing campaign can expand your practice to bring you more of the type of patient you want to treat. Although ObGyns are often not trained in marketing, we can bring our practices to the attention of women who need our services with a few simple processes.

The American Marketing Association defines marketing as “the activity, set of institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large.”¹ Social media is described as various forms of online and mobile electronic communication with user-generated content.² Social media marketing is the application of traditional marketing strategies to a social media platform. Delivering an effective social media marketing campaign requires focused targeting of a particular community to match the needs of those patients with the value of services and products your practice provides.

By communicating and connecting with the spoken and unspoken needs and desires of potential patients, you will generate greater enthusiasm for your medical services. Social media marketing benefits include: accessibility, low cost, the ability to build brand recognition and social capital, and the availability of analytics that provide large amounts of data to measure the effectiveness of the campaign.³

Though social media is pervasive, the medical community has not rapidly embraced it for marketing.^4,5 Creating a social media strategy, rather than randomly or impulsively posting on social media, allows for more effective marketing. The discussion here focuses on Facebook, which has 2 billion monthly users,⁶ but these strategies and tactics can be applied to any social media platform, including YouTube, Instagram, and Twitter.⁷

Use Facebook to create a business page

Your medical practice needs to have a Facebook account and a Facebook page, separate from your personal account. A business-related Facebook page is similar to a personal Facebook profile except that pages are designed for organizations, brands, businesses, and public figures to share photos, stories, and events with the public.

If you do not have a Facebook account, you can create a new account and profile at http://www.facebook.com. After creating a profile, click on the “create a Facebook page” link. Follow the instructions and select the page category you would like to create; most physicians would select the “Company,” “Organization,” or “Institution” category. Next, follow the instructions to complete the registration.⁸ Once your Facebook page is created, build an audience asking others to “like” your page. Start posting content and use hashtags in your posts to make them discoverable to others (ie, #fibroids #noscar #singlesitesurgery).⁹

Related article:
Using the Internet in your practice. Part 2: Generating new patients using social media

One benefit to having a practice-based Facebook page is the automated visible analytics that come with the page, which are not available for personal profiles. When you write a post or upload a photo or video, Facebook provides the demographics of those engaged with your posts plus analytics on that post, including the number of people who viewed the post, clicked on a photo, and viewed the video for more than 3 seconds.

Read how to get patients interested in your practice

Develop a social media marketing strategy

There are several key factors to consider when planning a strategy. First, know the mission of your organization and the specific service, value, or benefit you would like to provide to the targeted community.⁸

Segment, target, and position (STP)

It is tempting to try to reach out to all women because your ObGyn practice entails pre‑natal care, family planning, and gynecologic surgery, but by narrowing your target audience, your campaign will be better focused. A very specific target audience can reduce the costs for “boosting” (paid promotion of your posts on Facebook to a chosen audience based on demographics, interests, and behaviors) your posts and improve your return on investment (ROI).

Create different marketing campaigns, but focus on one at a time. Decide on the ideal patient you want to serve in your practice. The more detailed and focused you are about the demographics and type of medical needs to be served, the better you can target this patient.¹⁰

Segment. Divide the communities you are considering into different segments. For instance, even though you may do obstetrics and gynecologic surgery, consider breaking up the campaign to focus on 1 specific group, such as those interested in fibroid management.

Target. Identify the kinds of communities where you might find this patient. For example, if you want to focus on laparoscopic hysterectomies or myomectomies, start looking on Facebook for groups, pages, or website discussion boards or blogs that discuss abnormal uterine bleeding or fibroids and follow those pages.

Also, think about what other characteristics are associated with these ideal patients. For example, you might narrow it down to perimenopausal women with fibroids. A potential targeted group could be 40- to 50-year-old women who participate in yoga or running who have concerns about fibroids interfering in their active lifestyle. Perhaps this type of patient would want a minimally invasive surgical approach. A holistic health activist might be interested in nonsurgical management of fibroids.

Position. Once you have identified the specific community to target, position your practice within the community with the value proposition you are offering. For example, as an ObGyn who is focused on surgery, your position might be that your practice will provide the best experience for those medical services, with specific counseling to patients about resuming their active lifestyle.

Related article:
Four pillars of a successful practice: 2. Attract new patients

Get your potential patient to “raise her hand.” In the campaign, you are not trying to convince everyone up front to schedule an appointment from one post. First, try to get people who may be interested in your service(s) to “raise their hands.” Once your target market has expressed interest, either by their likes of your post, likes of your page, or other engagement, reach out to them with links for more information, such as free fibroid surgery education materials located on your website. On your website, create an opt-in page asking them to register their email address; once you have a compiled email list, send out monthly newsletters on your practice.¹¹

Read how to guide patients to your office

Understand that marketing is a process

Think of marketing as an overall process in which you are guiding potential patients to come to your office. Your campaign has several steps; recognize that just one post will not make a huge difference. Use Facebook analytics to measure cost per engagement to calculate your return on investment and the campaign’s effectiveness, and revise as necessary.

Rather than just considering social media as a soap box to advertise your practice, break up the marketing process into 3 units: the before unit, the during unit, and the after unit.¹¹ The word “unit” denotes the service, benefit, or product you are providing.

The before unit refers to the initial marketing that identifies potential patients—initially getting them to raise their hands and ultimately building an audience. (Once a potential patient provides her email address, you can send her a monthly newsletter or updates about your practice to continue the engagement.) Statistics show that an ObGyn needs to have 7 contacts, on average, with a patient over 18 months to “penetrate” her consciousness in a given market.¹² Of course if there is an urgent or emergent need to see a physician, that timeline would be much shorter.

The during unit occurs when the patient comes to your practice and service is being provided. Since you know what she is coming for, you can create informational packets focused on her particular needs, perhaps about different management options for fibroids.

The after unit includes following up with the patient in some automated way. For those being treated for fibroids, it may be a reminder email that discusses the value of follow-up ultrasonography or the various kinds of surgical interventions for fibroids.

In order to continue your campaign, it is helpful to have a designated social media manager who will continue the social media posts and engagement.

When creating the posts, consider developing prescheduled assets (posts that are already produced with photos or links to articles), which can be done through Facebook or Hootsuite (http://www.hootsuite.com).

Manage the risks of social media interaction

There are risks associated with social media. Some things to consider are:

• Policy. Develop a policy for your practice; if you work for an institution, align your policy with the institution’s.
• Postings. Supervise content being posted. Never allow social media to be placed by someone without supervision. Either you should do this or assign a manager to be accountable to check on social media interactions so that any inappropriate comments can be addressed immediately.
• Privacy. Never mention patients’ private health information or use the platform to publicly engage with a patient or future patient about their care. Do not post any references to patients or their photos without written consent.
• Images. Use photographs and other images properly: obtain releases and obey copyright laws.

Related article:
Your patients are talking: Isn’t it time you take responsibility for your online reputation?

Bottom line

Social media is a powerful platform. Combined with good marketing strategies, social media campaigns can have a significant impact on expanding your practice to offer the kind of medical services you want to provide.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

There are no large randomized clinical trials exploring the relationship between COCs and the risk of developing cancer. Many epidemiological studies, however, have investigated the possible association between COC use and the risk of cancer. Such prospective and retrospective studies consistently report that the use of COCs significantly decreases the risk of ovarian and endometrial cancer. The epidemiological data are less consistent concerning the possible association between COC use and the risk of breast cancer. Meta-analyses conclude that current use of COCs may be associated with a small increase in breast cancer risk. In addition, prolonged use of COCs may be associated with an increased risk of cervical cancer.

Ovarian cancer

• 0.78 (0.73–0.83) for 2.4 years
• 0.64 (0.59–0.69) for 6.8 years
• 0.56 (0.50–0.62) for 11.6 years
• 0.42 (0.36–0.49) for 18.3 years.

In the Royal College of General Practitioners Oral Contraceptive (RCGPOC) study, about 23,000 womenwho did not use COCs and 23,000 current users of COCs were recruited around 1968 and followed for a median of 41 years. In this study, current and recent use of COCs was associated with a decreased RR for ovarian cancer (0.49) and the risk reduction persisted for at least 35 years following COC discontinuation (RR, 0.50; 99% CI, 0.29–0.84).²

In the prospective Nurses’ Health Study (NHS) I, 121,700 nurses were recruited in 1976 and followed for more than 30 years.³ For nurses who reported using COCs for more than 5 years, the rate ratio for ovarian cancer at 20 years or less and greater than 20 years since last use was 0.58 (95% CI, 0.61–0.87) and 0.92 (95% CI, 0.61–1.39), respectively. These studies show that the association between COC use and a decreased risk of ovarian cancer persists for many years after discontinuing COCs.

Endometrial cancer

In the RCGPOC study of 46,000 women, the RR of endometrial cancer among current and recent users of COCs was 0.61, and the reduced risk (0.83) persisted for more than 35 years after discontinuing the COC.²

Related article:
2016 Update on cancer: Endometrial cancer

It is thought that the progestin in the COC provides most of the beneficial effect. Progestin-only contraceptives, such as depotmedroxyprogesterone acetate, progestin implants, and levonorgestrel-releasingintrauterine devices (LNG-IUDs) are also thought to reduce endometrial cancer risk. For instance, in a study of 93,842 Finnish women who used the LNG-IUD, the standardized incidence ratio for endometrial cancer was 0.50 among LNG-IUD users compared with the general population.⁵

Read about the effects of COC use in breast and cervical cancer.

Breast cancer

In the prospective NHS study of 116,608 nurses with 1,246,967 years of follow-up, the multivariate relative risk (mRR) of breast cancer with current COC use was 1.33 (95% CI, 1.03–1.73). Past use of COCs was not associated with a significantly increased risk of breast cancer (mRR, 1.12; 95% CI, 0.95–1.33; NS).⁷

In the RCGPOC study (approximately 46,000 women), current use of COCs was associated with an increased risk of breast cancer (incidence rate ratio [IRR], 1.48; 95% CI,1.10–1.97). Five to 15 years after stopping COCs, there was no significant association between prior COC use and breast cancer (IRR, 1.12; 99% CI, 0.91–1.39; NS).²

Related article:
Webcast: Oral contraceptives and breast cancer: What’s the risk?

It is important to note that it is not possible to conclude from these data whether the reported association between current use of COCs and breast cancer is due to early and accelerated diagnosis of breast cancer, the biological effects of hormones contained in COCs on breast tissue and nascent tumors, or both. In addition, formulations of COCs prescribed in the 1960s and 1970s contained higher doses of estrogen, raising the possibility that the association between COCs and breast cancer is due to COC formulations that are no longer prescribed. However, in animal models and postmenopausal women certain combinations of estrogen plus progestin clearly influence breast cancer biology and cancer risk.^8,9