OBG Management

In their advocacy column, “OTC hormonal contraception: An important goal in the fight for reproductive justice” (January 2020), Abby L. Schultz, MD, and Megan L. Evans, MD, MPH, discussed a recent committee opinion from the American College of Obstetricians and Gynecologists (ACOG) focused on improving contraception access by offering oral contraceptive pills, progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate over the counter (OTC). The authors agreed with ACOG’s stance and offered several reasons why.

OBG Management polled readers to see their thoughts on the question of whether or not hormonal contraception should be offered OTC.

In their advocacy column, “OTC hormonal contraception: An important goal in the fight for reproductive justice” (January 2020), Abby L. Schultz, MD, and Megan L. Evans, MD, MPH, discussed a recent committee opinion from the American College of Obstetricians and Gynecologists (ACOG) focused on improving contraception access by offering oral contraceptive pills, progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate over the counter (OTC). The authors agreed with ACOG’s stance and offered several reasons why.

OBG Management polled readers to see their thoughts on the question of whether or not hormonal contraception should be offered OTC.

In their advocacy column, “OTC hormonal contraception: An important goal in the fight for reproductive justice” (January 2020), Abby L. Schultz, MD, and Megan L. Evans, MD, MPH, discussed a recent committee opinion from the American College of Obstetricians and Gynecologists (ACOG) focused on improving contraception access by offering oral contraceptive pills, progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate over the counter (OTC). The authors agreed with ACOG’s stance and offered several reasons why.

OBG Management polled readers to see their thoughts on the question of whether or not hormonal contraception should be offered OTC.

While often compared with the Spanish influenza contagion of 1918, the current COVID-19 pandemic is arguably unprecedented in scale and scope, global reach, and the rate at which it has spread across the world.
 

Unprecedented times

The United States now has the greatest burden of COVID-19 disease worldwide.¹ Although Boston has thus far been spared the full force of the disease’s impact, it is likely only a matter of time before it reaches here. To prepare for the imminent surge, we at Tufts Medical Center defined 4 short-term strategic imperatives to help guide our COVID-19 preparedness. Having a single unified strategy across our organization has helped to maintain focus and consistency in the messaging amidst all of the uncertainty. Our focus areas are outlined below.
 

1 Flatten the curve

This term refers to the use of “social distancing” and community isolation measures to keep the number of disease cases at a manageable level. COVID-19 is spread almost exclusively through contact with contaminated respiratory droplets. While several categories of risk have been described, the US Centers for Disease Control and Prevention (CDC) defines disease “exposure” as face-to-face contact within 6 feet of an infected individual for more than 15 minutes without wearing a mask.² Intervening at all 3 of these touchpoints effectively reduces transmission. Interventions include limiting in-person meetings, increasing the space between individuals (both providers and patients), and routinely using personal protective equipment (PPE).

Another effective strategy is to divide frontline providers into smaller units or teams to limit cross-contamination: the inpatient team versus the outpatient team, the day team versus the night team, the “on” team versus the “off” team. If the infection lays one team low, other providers can step in until they recover and return to work.

Visitor policies should be developed and strictly implemented. Many institutions do allow one support person in labor and delivery (L&D) regardless of the patient’s COVID-19 status, although that person should not be symptomatic or COVID-19 positive. Whether to test all patients and support persons for COVID-19 on arrival at L&D remains controversial.³ At a minimum, these individuals should be screened for symptoms. Although it was a major focus of initial preventative efforts, taking a travel and exposure history is no longer informative as the virus is now endemic and community spread is common.

Initial preventative efforts focused also on high-risk patients, but routine use of PPE for all encounters clearly is more effective because of the high rate of asymptomatic shedding. The virus can survive suspended in the air for up to 2 hours following an aerosol-generating procedure (AGP) and on surfaces for several hours or even days. Practices such as regular handwashing, cleaning of exposed work surfaces, and avoiding face touching should by now be part of our everyday routine.

Institutions throughout the United States have established inpatient COVID-19 units—so-called “dirty” units—with mixed success. As the pandemic spreads and the number of patients with asymptomatic shedding increases, it is harder to determine who is and who is not infected. Cross-contamination has rendered this approach largely ineffective. Whether this will change with the introduction of rapid point-of-care testing remains to be seen.

Continue to: 2 Preserve PPE...

2 Preserve PPE

PPE use is effective in reducing transmission. This includes tier 1 PPE with or without enhanced droplet precaution (surgical mask, eye protection, gloves, yellow gown) and tier 2 PPE (tier 1 plus N95 respirators or powered air-purifying respirators [PAPR]). Given the acute PPE shortage in many parts of the country, appropriate use of PPE is critical to maintain an adequate supply. For example, tier 2 PPE is required only in the setting of an AGP. This includes intubation and, in our determination, the second stage of labor for COVID-19–positive patients and patients under investigation (PUIs); we do not employ tier 2 PPE for all patients in the second stage of labor, although some hospitals endorse this practice.

Creative solutions to the impending PPE shortage abound, such as the use of 3D printers to make face shields and novel techniques to sterilize and reuse N95 respirators.

3 Create capacity

In the absence of effective treatment for COVID-19 and with a vaccine still many months away, supportive care is critical. The pulmonary sequelae with cytokine storm and acute hypoxemia can come on quickly, require urgent mechanical ventilatory support, and take several weeks to resolve.

Our ability to create inpatient capacity to accommodate ill patients, monitor them closely, and intubate early will likely be the most critical driver of the case fatality rate. This requires deferring outpatient visits (or doing them via telemedicine), expanding intensive care unit capabilities (especially ventilator beds), and canceling elective surgeries. What constitutes “elective surgery” is not always clear. Our institution, for example, regards abortion services as essential and not elective, but this is not the case throughout the United States.

Creating capacity also refers to staffing. Where necessary, providers should be retrained and redeployed. This may require emergency credentialing of providers in areas outside their usual clinical practice and permission may be needed from the Accreditation Council for Graduate Medical Education to engage trainees outside their usual duty hours.
 

4 Support and protect your workforce

Everyone is anxious, and people convey their anxiety in different ways. I have found it helpful to acknowledge those feelings and provide a forum for staff to express and share their anxieties. That said, hospitals are not a democracy. While staff members should be encouraged to ask questions and voice their opinions, everyone is expected to follow protocol regarding patient care.

Celebrating small successes and finding creative ways to alleviate the stress and inject humor can help. Most institutions are using electronic conferencing platforms (such as Zoom or Microsoft Teams) to stay in touch and to continue education initiatives through interactive didactic sessions, grand rounds, morbidity and mortality conferences, and e-journal clubs. These are also a great platform for social events, such as w(h)ine and book clubs and virtual karaoke.

Since many ObGyn providers are women, the closure of day-care centers and schools is particularly challenging. Share best practices among your staff on how to address this problem, such as alternating on-call shifts or matching providers needing day care with ‘furloughed’ college students who are looking to keep busy and make a little money.

Continue to: Avoid overcommunicating...

Avoid overcommunicating

Clear, concise, and timely communication is key. This can be challenging given the rapidly evolving science of COVID-19 and the daily barrage of information from both reliable and unreliable sources. Setting up regular online meetings with your faculty 2 or 3 times per week can keep people informed, promote engagement, and boost morale.

If an urgent e-mail announcement is needed, keep the message focused. Highlight only updated information and changes to existing policies and guidelines. And consider adding a brief anecdote to illustrate the staff’s creativity and resilience: a “best catch” story, for example, or a staff member who started a “commit to sit” program (spending time in the room with patients who want company but are not able to have their family in attendance).
 

Look to the future

COVID-19 will pass. Herd immunity will inevitably develop. The question is how quickly and at what cost. Children delivered today are being born into a society already profoundly altered by COVID-19. Some have started to call them Generation C.

Exactly what life will look like at the back end of this pandemic depends on how effectively we leverage this crisis. There are numerous opportunities to change the way we think about health care and educate the next generation of providers. These include increasing the use of telehealth and remote education, redesigning our traditional prenatal care paradigms, and reinforcing the importance of preventive medicine. This is an opportunity to put the “health” back into “health care.”

Look after yourself

Amid all the chaos and uncertainty, do not forget to take care of yourself and your family. Be calm, be kind, and be flexible. Stay safe.

While often compared with the Spanish influenza contagion of 1918, the current COVID-19 pandemic is arguably unprecedented in scale and scope, global reach, and the rate at which it has spread across the world.
 

Unprecedented times

The United States now has the greatest burden of COVID-19 disease worldwide.¹ Although Boston has thus far been spared the full force of the disease’s impact, it is likely only a matter of time before it reaches here. To prepare for the imminent surge, we at Tufts Medical Center defined 4 short-term strategic imperatives to help guide our COVID-19 preparedness. Having a single unified strategy across our organization has helped to maintain focus and consistency in the messaging amidst all of the uncertainty. Our focus areas are outlined below.
 

1 Flatten the curve

This term refers to the use of “social distancing” and community isolation measures to keep the number of disease cases at a manageable level. COVID-19 is spread almost exclusively through contact with contaminated respiratory droplets. While several categories of risk have been described, the US Centers for Disease Control and Prevention (CDC) defines disease “exposure” as face-to-face contact within 6 feet of an infected individual for more than 15 minutes without wearing a mask.² Intervening at all 3 of these touchpoints effectively reduces transmission. Interventions include limiting in-person meetings, increasing the space between individuals (both providers and patients), and routinely using personal protective equipment (PPE).

Another effective strategy is to divide frontline providers into smaller units or teams to limit cross-contamination: the inpatient team versus the outpatient team, the day team versus the night team, the “on” team versus the “off” team. If the infection lays one team low, other providers can step in until they recover and return to work.

Visitor policies should be developed and strictly implemented. Many institutions do allow one support person in labor and delivery (L&D) regardless of the patient’s COVID-19 status, although that person should not be symptomatic or COVID-19 positive. Whether to test all patients and support persons for COVID-19 on arrival at L&D remains controversial.³ At a minimum, these individuals should be screened for symptoms. Although it was a major focus of initial preventative efforts, taking a travel and exposure history is no longer informative as the virus is now endemic and community spread is common.

Initial preventative efforts focused also on high-risk patients, but routine use of PPE for all encounters clearly is more effective because of the high rate of asymptomatic shedding. The virus can survive suspended in the air for up to 2 hours following an aerosol-generating procedure (AGP) and on surfaces for several hours or even days. Practices such as regular handwashing, cleaning of exposed work surfaces, and avoiding face touching should by now be part of our everyday routine.

Institutions throughout the United States have established inpatient COVID-19 units—so-called “dirty” units—with mixed success. As the pandemic spreads and the number of patients with asymptomatic shedding increases, it is harder to determine who is and who is not infected. Cross-contamination has rendered this approach largely ineffective. Whether this will change with the introduction of rapid point-of-care testing remains to be seen.

Continue to: 2 Preserve PPE...

2 Preserve PPE

PPE use is effective in reducing transmission. This includes tier 1 PPE with or without enhanced droplet precaution (surgical mask, eye protection, gloves, yellow gown) and tier 2 PPE (tier 1 plus N95 respirators or powered air-purifying respirators [PAPR]). Given the acute PPE shortage in many parts of the country, appropriate use of PPE is critical to maintain an adequate supply. For example, tier 2 PPE is required only in the setting of an AGP. This includes intubation and, in our determination, the second stage of labor for COVID-19–positive patients and patients under investigation (PUIs); we do not employ tier 2 PPE for all patients in the second stage of labor, although some hospitals endorse this practice.

Creative solutions to the impending PPE shortage abound, such as the use of 3D printers to make face shields and novel techniques to sterilize and reuse N95 respirators.

3 Create capacity

In the absence of effective treatment for COVID-19 and with a vaccine still many months away, supportive care is critical. The pulmonary sequelae with cytokine storm and acute hypoxemia can come on quickly, require urgent mechanical ventilatory support, and take several weeks to resolve.

Our ability to create inpatient capacity to accommodate ill patients, monitor them closely, and intubate early will likely be the most critical driver of the case fatality rate. This requires deferring outpatient visits (or doing them via telemedicine), expanding intensive care unit capabilities (especially ventilator beds), and canceling elective surgeries. What constitutes “elective surgery” is not always clear. Our institution, for example, regards abortion services as essential and not elective, but this is not the case throughout the United States.

Creating capacity also refers to staffing. Where necessary, providers should be retrained and redeployed. This may require emergency credentialing of providers in areas outside their usual clinical practice and permission may be needed from the Accreditation Council for Graduate Medical Education to engage trainees outside their usual duty hours.
 

4 Support and protect your workforce

Everyone is anxious, and people convey their anxiety in different ways. I have found it helpful to acknowledge those feelings and provide a forum for staff to express and share their anxieties. That said, hospitals are not a democracy. While staff members should be encouraged to ask questions and voice their opinions, everyone is expected to follow protocol regarding patient care.

Celebrating small successes and finding creative ways to alleviate the stress and inject humor can help. Most institutions are using electronic conferencing platforms (such as Zoom or Microsoft Teams) to stay in touch and to continue education initiatives through interactive didactic sessions, grand rounds, morbidity and mortality conferences, and e-journal clubs. These are also a great platform for social events, such as w(h)ine and book clubs and virtual karaoke.

Since many ObGyn providers are women, the closure of day-care centers and schools is particularly challenging. Share best practices among your staff on how to address this problem, such as alternating on-call shifts or matching providers needing day care with ‘furloughed’ college students who are looking to keep busy and make a little money.

Continue to: Avoid overcommunicating...

Avoid overcommunicating

Clear, concise, and timely communication is key. This can be challenging given the rapidly evolving science of COVID-19 and the daily barrage of information from both reliable and unreliable sources. Setting up regular online meetings with your faculty 2 or 3 times per week can keep people informed, promote engagement, and boost morale.

If an urgent e-mail announcement is needed, keep the message focused. Highlight only updated information and changes to existing policies and guidelines. And consider adding a brief anecdote to illustrate the staff’s creativity and resilience: a “best catch” story, for example, or a staff member who started a “commit to sit” program (spending time in the room with patients who want company but are not able to have their family in attendance).
 

Look to the future

COVID-19 will pass. Herd immunity will inevitably develop. The question is how quickly and at what cost. Children delivered today are being born into a society already profoundly altered by COVID-19. Some have started to call them Generation C.

Exactly what life will look like at the back end of this pandemic depends on how effectively we leverage this crisis. There are numerous opportunities to change the way we think about health care and educate the next generation of providers. These include increasing the use of telehealth and remote education, redesigning our traditional prenatal care paradigms, and reinforcing the importance of preventive medicine. This is an opportunity to put the “health” back into “health care.”

Look after yourself

Amid all the chaos and uncertainty, do not forget to take care of yourself and your family. Be calm, be kind, and be flexible. Stay safe.

While often compared with the Spanish influenza contagion of 1918, the current COVID-19 pandemic is arguably unprecedented in scale and scope, global reach, and the rate at which it has spread across the world.
 

Unprecedented times

The United States now has the greatest burden of COVID-19 disease worldwide.¹ Although Boston has thus far been spared the full force of the disease’s impact, it is likely only a matter of time before it reaches here. To prepare for the imminent surge, we at Tufts Medical Center defined 4 short-term strategic imperatives to help guide our COVID-19 preparedness. Having a single unified strategy across our organization has helped to maintain focus and consistency in the messaging amidst all of the uncertainty. Our focus areas are outlined below.
 

1 Flatten the curve

This term refers to the use of “social distancing” and community isolation measures to keep the number of disease cases at a manageable level. COVID-19 is spread almost exclusively through contact with contaminated respiratory droplets. While several categories of risk have been described, the US Centers for Disease Control and Prevention (CDC) defines disease “exposure” as face-to-face contact within 6 feet of an infected individual for more than 15 minutes without wearing a mask.² Intervening at all 3 of these touchpoints effectively reduces transmission. Interventions include limiting in-person meetings, increasing the space between individuals (both providers and patients), and routinely using personal protective equipment (PPE).

Another effective strategy is to divide frontline providers into smaller units or teams to limit cross-contamination: the inpatient team versus the outpatient team, the day team versus the night team, the “on” team versus the “off” team. If the infection lays one team low, other providers can step in until they recover and return to work.

Visitor policies should be developed and strictly implemented. Many institutions do allow one support person in labor and delivery (L&D) regardless of the patient’s COVID-19 status, although that person should not be symptomatic or COVID-19 positive. Whether to test all patients and support persons for COVID-19 on arrival at L&D remains controversial.³ At a minimum, these individuals should be screened for symptoms. Although it was a major focus of initial preventative efforts, taking a travel and exposure history is no longer informative as the virus is now endemic and community spread is common.

Initial preventative efforts focused also on high-risk patients, but routine use of PPE for all encounters clearly is more effective because of the high rate of asymptomatic shedding. The virus can survive suspended in the air for up to 2 hours following an aerosol-generating procedure (AGP) and on surfaces for several hours or even days. Practices such as regular handwashing, cleaning of exposed work surfaces, and avoiding face touching should by now be part of our everyday routine.

Institutions throughout the United States have established inpatient COVID-19 units—so-called “dirty” units—with mixed success. As the pandemic spreads and the number of patients with asymptomatic shedding increases, it is harder to determine who is and who is not infected. Cross-contamination has rendered this approach largely ineffective. Whether this will change with the introduction of rapid point-of-care testing remains to be seen.

Continue to: 2 Preserve PPE...

2 Preserve PPE

PPE use is effective in reducing transmission. This includes tier 1 PPE with or without enhanced droplet precaution (surgical mask, eye protection, gloves, yellow gown) and tier 2 PPE (tier 1 plus N95 respirators or powered air-purifying respirators [PAPR]). Given the acute PPE shortage in many parts of the country, appropriate use of PPE is critical to maintain an adequate supply. For example, tier 2 PPE is required only in the setting of an AGP. This includes intubation and, in our determination, the second stage of labor for COVID-19–positive patients and patients under investigation (PUIs); we do not employ tier 2 PPE for all patients in the second stage of labor, although some hospitals endorse this practice.

Creative solutions to the impending PPE shortage abound, such as the use of 3D printers to make face shields and novel techniques to sterilize and reuse N95 respirators.

3 Create capacity

In the absence of effective treatment for COVID-19 and with a vaccine still many months away, supportive care is critical. The pulmonary sequelae with cytokine storm and acute hypoxemia can come on quickly, require urgent mechanical ventilatory support, and take several weeks to resolve.

Our ability to create inpatient capacity to accommodate ill patients, monitor them closely, and intubate early will likely be the most critical driver of the case fatality rate. This requires deferring outpatient visits (or doing them via telemedicine), expanding intensive care unit capabilities (especially ventilator beds), and canceling elective surgeries. What constitutes “elective surgery” is not always clear. Our institution, for example, regards abortion services as essential and not elective, but this is not the case throughout the United States.

Creating capacity also refers to staffing. Where necessary, providers should be retrained and redeployed. This may require emergency credentialing of providers in areas outside their usual clinical practice and permission may be needed from the Accreditation Council for Graduate Medical Education to engage trainees outside their usual duty hours.
 

4 Support and protect your workforce

Everyone is anxious, and people convey their anxiety in different ways. I have found it helpful to acknowledge those feelings and provide a forum for staff to express and share their anxieties. That said, hospitals are not a democracy. While staff members should be encouraged to ask questions and voice their opinions, everyone is expected to follow protocol regarding patient care.

Celebrating small successes and finding creative ways to alleviate the stress and inject humor can help. Most institutions are using electronic conferencing platforms (such as Zoom or Microsoft Teams) to stay in touch and to continue education initiatives through interactive didactic sessions, grand rounds, morbidity and mortality conferences, and e-journal clubs. These are also a great platform for social events, such as w(h)ine and book clubs and virtual karaoke.

Since many ObGyn providers are women, the closure of day-care centers and schools is particularly challenging. Share best practices among your staff on how to address this problem, such as alternating on-call shifts or matching providers needing day care with ‘furloughed’ college students who are looking to keep busy and make a little money.

Continue to: Avoid overcommunicating...

Avoid overcommunicating

Clear, concise, and timely communication is key. This can be challenging given the rapidly evolving science of COVID-19 and the daily barrage of information from both reliable and unreliable sources. Setting up regular online meetings with your faculty 2 or 3 times per week can keep people informed, promote engagement, and boost morale.

If an urgent e-mail announcement is needed, keep the message focused. Highlight only updated information and changes to existing policies and guidelines. And consider adding a brief anecdote to illustrate the staff’s creativity and resilience: a “best catch” story, for example, or a staff member who started a “commit to sit” program (spending time in the room with patients who want company but are not able to have their family in attendance).
 

Look to the future

COVID-19 will pass. Herd immunity will inevitably develop. The question is how quickly and at what cost. Children delivered today are being born into a society already profoundly altered by COVID-19. Some have started to call them Generation C.

Exactly what life will look like at the back end of this pandemic depends on how effectively we leverage this crisis. There are numerous opportunities to change the way we think about health care and educate the next generation of providers. These include increasing the use of telehealth and remote education, redesigning our traditional prenatal care paradigms, and reinforcing the importance of preventive medicine. This is an opportunity to put the “health” back into “health care.”

Look after yourself

Amid all the chaos and uncertainty, do not forget to take care of yourself and your family. Be calm, be kind, and be flexible. Stay safe.

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.¹

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

• suspected ectopic pregnancy
• profuse vaginal bleeding

Video or telephone visits

• contraceptive counseling and prescribing
• management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

• routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that²:

• for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
• for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.¹

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

• suspected ectopic pregnancy
• profuse vaginal bleeding

Video or telephone visits

• contraceptive counseling and prescribing
• management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

• routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that²:

• for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
• for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.¹

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

• suspected ectopic pregnancy
• profuse vaginal bleeding

Video or telephone visits

• contraceptive counseling and prescribing
• management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

• routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that²:

• for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
• for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Expert Commentary

Any women’s health care provider is extremely aware of how common uterine fibroids (leiomyomas) are in reproductive-aged women. Bleeding associated with such fibroids is a common source of medical morbidity and reduced quality of life for many patients. The mainstay treatment approach for such patients has been surgical, which over time has become minimally invasive. Finding a nonsurgical treatment for patients with fibroid-associated HMB is of huge importance. The recent failure of the selective progesterone receptor modulator ulipristal acetate to be approved by the US Food and Drug Administration (FDA) was a significant setback to finding an excellent option for medical management. A gonadotropin-releasing hormone (GnRH) antagonist like elagolix could become an incredibly important “arrow in the quiver” of women’s health clinicians.

Details about elagolix

As mentioned, elagolix was FDA approved in 2-dose regimens for the treatment of dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia associated with endometriosis. One would expect that such a GnRH antagonist would reduce or eliminate HMB in patients with fibroids, although formal study had never been undertaken. Previous studies of elagolix had shown the most common adverse reaction to be vasomotor symptoms—hot flashes and night sweats. In addition, the drug shows a dose-dependent decrease in bone mineral density (BMD), although its effect on long-term bone health and future fracture risk is unknown.¹

Study specifics. The current study by Schlaff and colleagues was performed including 3 arms: a placebo arm, an elagolix 300 mg twice daily arm, and a third arm that received elagolix 300 mg twice daily and hormonal “add-back” therapy in the form of estradiol 1 mg and norethindrone acetate 0.5 mg daily. The authors actually report on two phase 3 six-month trials that were identical, double-blind, and randomized in nature. Both trials involved approximately 400 women. About 70% of the study participants overall were black, and the average age was approximately 42 years (range, 18 to 51). At baseline, BMD scores were mostly in the normal range. HMB for inclusion was defined as a volume of more than 80 mL per month.

The primary end point was menstrual blood loss volume less than 80 mL in the final month and at least a 50% reduction in menstrual blood loss from baseline to the final month. In the placebo group, only 9% and 10%, respectively, met these criteria.

Continue to: Results...

Results. In the first study group, 84% of those receiving elagolix alone achieved the primary end point, while the group that received elagolix plus add-back therapy had 69% success.

In the second study, both the elagolix group and the add-back group showed that 77% of patients met the primary end point criteria.

The incidences of hot flashes in the elagolix-alone groups were 64% and 43%, respectively, while with add-back therapy, they were 20% in both trials. In the placebo groups, 9% and 4% of participants reported hot flashes. At 6 months, the elagolix-only groups in both trials lost more BMD than the placebo groups, while BMD loss in both add-back groups was not statistically significant from the placebo groups.

Study strengths

Schlaff and colleagues conducted a very well-designed study. The two phase 3 clinical trials in preparation for drug approval were thorough and well reported. The authors are to be commended for including nearly 70% black women as study participants, since this is a racial group known to be affected by HMB resulting from fibroids.

Another strength was the addition of add-back therapy to the doses of elagolix. Concerns about bone loss from a health perspective and vasomotor symptoms from a quality-of-life perspective are not insignificant with elagolix-alone treatment, and proof that add-back therapy significantly diminishes or attenuates the efficacy of this entity is extremely important.

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Expert Commentary

Any women’s health care provider is extremely aware of how common uterine fibroids (leiomyomas) are in reproductive-aged women. Bleeding associated with such fibroids is a common source of medical morbidity and reduced quality of life for many patients. The mainstay treatment approach for such patients has been surgical, which over time has become minimally invasive. Finding a nonsurgical treatment for patients with fibroid-associated HMB is of huge importance. The recent failure of the selective progesterone receptor modulator ulipristal acetate to be approved by the US Food and Drug Administration (FDA) was a significant setback to finding an excellent option for medical management. A gonadotropin-releasing hormone (GnRH) antagonist like elagolix could become an incredibly important “arrow in the quiver” of women’s health clinicians.

Details about elagolix

As mentioned, elagolix was FDA approved in 2-dose regimens for the treatment of dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia associated with endometriosis. One would expect that such a GnRH antagonist would reduce or eliminate HMB in patients with fibroids, although formal study had never been undertaken. Previous studies of elagolix had shown the most common adverse reaction to be vasomotor symptoms—hot flashes and night sweats. In addition, the drug shows a dose-dependent decrease in bone mineral density (BMD), although its effect on long-term bone health and future fracture risk is unknown.¹

Study specifics. The current study by Schlaff and colleagues was performed including 3 arms: a placebo arm, an elagolix 300 mg twice daily arm, and a third arm that received elagolix 300 mg twice daily and hormonal “add-back” therapy in the form of estradiol 1 mg and norethindrone acetate 0.5 mg daily. The authors actually report on two phase 3 six-month trials that were identical, double-blind, and randomized in nature. Both trials involved approximately 400 women. About 70% of the study participants overall were black, and the average age was approximately 42 years (range, 18 to 51). At baseline, BMD scores were mostly in the normal range. HMB for inclusion was defined as a volume of more than 80 mL per month.

The primary end point was menstrual blood loss volume less than 80 mL in the final month and at least a 50% reduction in menstrual blood loss from baseline to the final month. In the placebo group, only 9% and 10%, respectively, met these criteria.

Continue to: Results...

Results. In the first study group, 84% of those receiving elagolix alone achieved the primary end point, while the group that received elagolix plus add-back therapy had 69% success.

In the second study, both the elagolix group and the add-back group showed that 77% of patients met the primary end point criteria.

The incidences of hot flashes in the elagolix-alone groups were 64% and 43%, respectively, while with add-back therapy, they were 20% in both trials. In the placebo groups, 9% and 4% of participants reported hot flashes. At 6 months, the elagolix-only groups in both trials lost more BMD than the placebo groups, while BMD loss in both add-back groups was not statistically significant from the placebo groups.

Study strengths

Schlaff and colleagues conducted a very well-designed study. The two phase 3 clinical trials in preparation for drug approval were thorough and well reported. The authors are to be commended for including nearly 70% black women as study participants, since this is a racial group known to be affected by HMB resulting from fibroids.

Another strength was the addition of add-back therapy to the doses of elagolix. Concerns about bone loss from a health perspective and vasomotor symptoms from a quality-of-life perspective are not insignificant with elagolix-alone treatment, and proof that add-back therapy significantly diminishes or attenuates the efficacy of this entity is extremely important.

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Expert Commentary

Any women’s health care provider is extremely aware of how common uterine fibroids (leiomyomas) are in reproductive-aged women. Bleeding associated with such fibroids is a common source of medical morbidity and reduced quality of life for many patients. The mainstay treatment approach for such patients has been surgical, which over time has become minimally invasive. Finding a nonsurgical treatment for patients with fibroid-associated HMB is of huge importance. The recent failure of the selective progesterone receptor modulator ulipristal acetate to be approved by the US Food and Drug Administration (FDA) was a significant setback to finding an excellent option for medical management. A gonadotropin-releasing hormone (GnRH) antagonist like elagolix could become an incredibly important “arrow in the quiver” of women’s health clinicians.

Details about elagolix

As mentioned, elagolix was FDA approved in 2-dose regimens for the treatment of dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia associated with endometriosis. One would expect that such a GnRH antagonist would reduce or eliminate HMB in patients with fibroids, although formal study had never been undertaken. Previous studies of elagolix had shown the most common adverse reaction to be vasomotor symptoms—hot flashes and night sweats. In addition, the drug shows a dose-dependent decrease in bone mineral density (BMD), although its effect on long-term bone health and future fracture risk is unknown.¹

Study specifics. The current study by Schlaff and colleagues was performed including 3 arms: a placebo arm, an elagolix 300 mg twice daily arm, and a third arm that received elagolix 300 mg twice daily and hormonal “add-back” therapy in the form of estradiol 1 mg and norethindrone acetate 0.5 mg daily. The authors actually report on two phase 3 six-month trials that were identical, double-blind, and randomized in nature. Both trials involved approximately 400 women. About 70% of the study participants overall were black, and the average age was approximately 42 years (range, 18 to 51). At baseline, BMD scores were mostly in the normal range. HMB for inclusion was defined as a volume of more than 80 mL per month.

The primary end point was menstrual blood loss volume less than 80 mL in the final month and at least a 50% reduction in menstrual blood loss from baseline to the final month. In the placebo group, only 9% and 10%, respectively, met these criteria.

Continue to: Results...

Results. In the first study group, 84% of those receiving elagolix alone achieved the primary end point, while the group that received elagolix plus add-back therapy had 69% success.

In the second study, both the elagolix group and the add-back group showed that 77% of patients met the primary end point criteria.

The incidences of hot flashes in the elagolix-alone groups were 64% and 43%, respectively, while with add-back therapy, they were 20% in both trials. In the placebo groups, 9% and 4% of participants reported hot flashes. At 6 months, the elagolix-only groups in both trials lost more BMD than the placebo groups, while BMD loss in both add-back groups was not statistically significant from the placebo groups.

Study strengths

Schlaff and colleagues conducted a very well-designed study. The two phase 3 clinical trials in preparation for drug approval were thorough and well reported. The authors are to be commended for including nearly 70% black women as study participants, since this is a racial group known to be affected by HMB resulting from fibroids.

Another strength was the addition of add-back therapy to the doses of elagolix. Concerns about bone loss from a health perspective and vasomotor symptoms from a quality-of-life perspective are not insignificant with elagolix-alone treatment, and proof that add-back therapy significantly diminishes or attenuates the efficacy of this entity is extremely important.

The sexually transmitted disease (STD) epidemic in the United States is intensifying, and it disproportionately impacts high-risk communities. In 2018, rates of reportable STDs, including syphilis and Neisseria gonorrhoeae and Chlamydia trachomatis infections, reached an all-time high.¹ That year, there were 1.8 million cases of chlamydia (increased 19% since 2014), 583,405 cases of gonorrhea (increased 63% since 2014), and 35,063 cases of primary and secondary syphilis (71% increase from 2014).¹

Cases of newborn syphilis have more than doubled in 4 years, with rates reaching a 20-year high.¹

This surge has not received the attention it deserves given the broad-reaching impact of these infections on women’s health and maternal-child health.² As ObGyns, we are on the front line, and we need to be engaged in evidence-based strategies and population-based health initiatives to expedite diagnoses and treatment and to reduce the ongoing spread of these infections.

Disparities exist and continue to fuel this epidemic

The STD burden is disproportionately high among reproductive-aged women, and half of all reported STDs occur in women aged 15 to 24 years. African American women have rates up to 12 times higher than white women.^3,4 Substantial geographic variability also exists, with the South, Southeast, and West having some of the highest STD rates.

These disparities are fueled by inequalities in socioeconomic status (SES), including employment, insurance, education, incarceration, stress/trauma exposure, and discrimination.^5-7 Those with lower SES often have trouble accessing and affording quality health care, including sexual health services. Access to quality health care, including STD prevention and treatment, that meets the needs of lower SES populations is key to reducing STD disparities in the United States; however, access likely will be insufficient unless the structural inequities that drive these disparities are addressed.

Clinical consequences for women, infants, and mothers

STDs are most prevalent among reproductive-aged women and can lead to pelvic inflammatory disease, infertility, ectopic pregnancy,^4,8 and increased risk of acquiring human immunodeficiency virus (HIV). STDs during pregnancy present additional consequences. Congenital syphilis is perhaps the most salient, with neonates experiencing substantial disability or death.

In addition, STDs contribute to overall peripartum and long-term adverse health outcomes.^4,9,10 Untreated chlamydia infection, for example, is associated with neonatal pneumonia, neonatal conjunctivitis, low birth weight, premature rupture of membranes, preterm labor, and postpartum endometritis.^2,11 Untreated gonorrhea is linked to disseminated gonococcal infection in the newborn, neonatal conjunctivitis, low birth weight, miscarriage, premature rupture of membranes, preterm labor, and chorioamnionitis.^2,12

As preterm birth is the leading cause of infant morbidity and mortality and disproportionately affects African American women and women in the southeastern United States,¹³ there is a critical public heath need to improve STD screening, treatment, and prevention of reinfection among high-risk pregnant women.

Quality clinical services for STDs: Areas for focus

More and more, STDs are being diagnosed in primary care settings. In January 2020, the Centers for Disease Control and Prevention (CDC) released a document, referred to as STD QCS (quality clinical services), that outlines recommendations for basic and specialty-level STD clinical services.¹⁴ ObGyns and other clinicians who provide primary care should meet the basic recommendations as a minimum.

The STD QCS outlines 8 recommendation areas: sexual history and physical examination, prevention, screening, partner services, evaluation of STD-related conditions, laboratory, treatment, and referral to a specialist for complex STD or STD-related conditions.¹⁴ These recommendations can be used by providers, managers, advocates, and others working to implement the highest-quality STD clinical services. Below are key areas that can be addressed in ObGyn practice.

Continue to: Sexual history and physical examination...

Sexual history and physical examination

A complete sexual history and risk assessment should be performed at a complete initial or annual visit and as indicated. Routinely updating the sexual history and risk assessment is important to normalize these questions within the frame of the person’s overall health, and it may be valuable in reducing stigma. This routine approach may be important particularly for younger patients and others whose risk for STDs may change frequently and dramatically.

Creating a safe space that permits privacy and assurance of confidentiality may help build trust and set the stage for disclosure. The American College of Obstetricians and Gynecologists recommends that all young people have time alone without parents for confidential counseling and discussion.¹⁵ All states allow minors to consent for STD services themselves, although 11 states limit this to those beyond a certain age.¹⁶

The CDC recommends using the 5 P’s—partners, practices, protection, past history of STDs, and prevention of pregnancy—as a guide for discussion.¹⁴ ObGyns are more likely than other providers to perform this screening routinely. While a pelvic examination should be available for STD evaluation as needed, it is not required for routine screening.

Prevention

ObGyns should employ several recommendations for STD prevention. These include providing or referring patients for vaccination against hepatitis B and human papillomavirus and providing brief STD/HIV prevention counseling along with contraceptive counseling. ObGyns should be familiar with HIV pre-exposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP) and provide risk assessment, education, and referral or link to HIV care. Providing these services would improve access to care and further remove barriers to care. ObGyns also could consider providing condoms in their offices.¹⁴

Screening

STD screening of women at risk is critical since more than 80% of infected women are asymptomatic.⁸ Because young people are disproportionately experiencing STDs, annual screening for chlamydia and gonorrhea is recommended for women younger than 25 years. For women older than 25, those at increased risk can be screened.

Risk factors for chlamydia infection include having new or multiple sex partners, sex partners with concurrent partners, or sex partners who have an STD. For gonorrhea, risk factors include living in a high-morbidity area, having a previous or coexisting STD, new or multiple sex partners, inconsistent condom use in people who are not in a mutually monogamous relationship, and exchanging sex for money or drugs. Screening for syphilis in nonpregnant women is recommended for those who have had any sexual activity with a person recently diagnosed with syphilis or those who personally display signs or symptoms of infection.¹⁷

STD screening is especially important for pregnant women, and treatment of infections may improve pregnancy outcomes. The CDC recommends screening at the first prenatal care visit for chlamydia and gonorrhea in pregnant women younger than 25 years of age and in older pregnant women at increased risk; women younger than 25 years or at continued high risk should be rescreened in their third trimester. The CDC recommends screening all women for syphilis at their first prenatal care visit and rescreening those at high risk in the third trimester and at delivery (TABLE).¹⁸

Continue to: Partner services...

Partner services

Clearly outlined partner management services is paramount for preventing STD reinfection.¹⁴ Reinfection rates for chlamydia and gonorrhea among young women are high and vary by study population.¹⁹ At a minimum, ObGyns should counsel patients with an STD that their partner(s) should be notified and encouraged to seek services.

For states in which it is legal, expedited partner therapy (EPT)—the clinician provides medication for the partner without seeing the partner—should be provided for chlamydia or gonorrhea if the partner is unlikely to access timely care. EPT is legal in most states. (To check the legal status of EPT in your state, visit https://www.cdc.gov/std/ept/legal/default.htm.) Research is needed to evaluate optimal strategies for effective implementation of EPT services in different clinical settings.

Laboratory tests

ObGyns should be able to provide a wide range of laboratory evaluations (for example, a nucleic acid amplification test [NAAT] for genital chlamydia and gonorrhea, quantitative nontreponemal serologic test for syphilis, treponemal serologic test for syphilis) that can be ordered for screening or diagnostic purposes. To improve rates of recommended screening, consider having clinic-level policies that support screening, such as standing orders, express or walk-in screening appointments, lab panels, and reflex testing.

Further, having rapid results or point-of-care testing available would help decrease lags in time to treatment. Delays in treatment are particularly important in lower-resource communities; thus, point-of-care testing may be especially valuable with immediate access to treatment on site.

Treatment

Adequate and timely treatment of STDs is critical to decrease sequelae and the likelihood of transmission to others. Treatment is evolving, particularly for gonorrhea. Over the past several years, gonorrhea has become resistant to 6 previously recommended treatment options.²⁰ Since 2015, the CDC recommends dual therapy for gonorrhea with an injection of ceftriaxone and oral azithromycin.

The first-line recommended treatments for bacterial STDs are listed in the TABLE. When possible, it is preferred to offer directly observed therapy at the time of the visit. This decreases the time to treatment and ensures that therapy is completed.

A call to action for ObGyns

Clinicians have multiple opportunities to address and reduce the surge of STDs in the United States. We play a critical role in screening, diagnosing, and treating patients, and it is thus imperative to be up-to-date on the recommended guidelines. Further, clinicians can advocate for more rapid testing modalities, with the goal of obtaining point-of-care testing results when possible and implementing strategies to improve partner treatment.

While a positive STD result may be associated with significant patient distress, it also may be an opportunity for enhancing the patient-provider relationship, coupling education with motivational approaches to help patients increase protective health behaviors.

It is critical to approach clinical care in a nonjudgmental manner to improve patients’ comfort in their relationship with the health care system. ●

The sexually transmitted disease (STD) epidemic in the United States is intensifying, and it disproportionately impacts high-risk communities. In 2018, rates of reportable STDs, including syphilis and Neisseria gonorrhoeae and Chlamydia trachomatis infections, reached an all-time high.¹ That year, there were 1.8 million cases of chlamydia (increased 19% since 2014), 583,405 cases of gonorrhea (increased 63% since 2014), and 35,063 cases of primary and secondary syphilis (71% increase from 2014).¹

Cases of newborn syphilis have more than doubled in 4 years, with rates reaching a 20-year high.¹

This surge has not received the attention it deserves given the broad-reaching impact of these infections on women’s health and maternal-child health.² As ObGyns, we are on the front line, and we need to be engaged in evidence-based strategies and population-based health initiatives to expedite diagnoses and treatment and to reduce the ongoing spread of these infections.

Disparities exist and continue to fuel this epidemic

The STD burden is disproportionately high among reproductive-aged women, and half of all reported STDs occur in women aged 15 to 24 years. African American women have rates up to 12 times higher than white women.^3,4 Substantial geographic variability also exists, with the South, Southeast, and West having some of the highest STD rates.

These disparities are fueled by inequalities in socioeconomic status (SES), including employment, insurance, education, incarceration, stress/trauma exposure, and discrimination.^5-7 Those with lower SES often have trouble accessing and affording quality health care, including sexual health services. Access to quality health care, including STD prevention and treatment, that meets the needs of lower SES populations is key to reducing STD disparities in the United States; however, access likely will be insufficient unless the structural inequities that drive these disparities are addressed.

Clinical consequences for women, infants, and mothers

STDs are most prevalent among reproductive-aged women and can lead to pelvic inflammatory disease, infertility, ectopic pregnancy,^4,8 and increased risk of acquiring human immunodeficiency virus (HIV). STDs during pregnancy present additional consequences. Congenital syphilis is perhaps the most salient, with neonates experiencing substantial disability or death.

In addition, STDs contribute to overall peripartum and long-term adverse health outcomes.^4,9,10 Untreated chlamydia infection, for example, is associated with neonatal pneumonia, neonatal conjunctivitis, low birth weight, premature rupture of membranes, preterm labor, and postpartum endometritis.^2,11 Untreated gonorrhea is linked to disseminated gonococcal infection in the newborn, neonatal conjunctivitis, low birth weight, miscarriage, premature rupture of membranes, preterm labor, and chorioamnionitis.^2,12

As preterm birth is the leading cause of infant morbidity and mortality and disproportionately affects African American women and women in the southeastern United States,¹³ there is a critical public heath need to improve STD screening, treatment, and prevention of reinfection among high-risk pregnant women.

Quality clinical services for STDs: Areas for focus

More and more, STDs are being diagnosed in primary care settings. In January 2020, the Centers for Disease Control and Prevention (CDC) released a document, referred to as STD QCS (quality clinical services), that outlines recommendations for basic and specialty-level STD clinical services.¹⁴ ObGyns and other clinicians who provide primary care should meet the basic recommendations as a minimum.

The STD QCS outlines 8 recommendation areas: sexual history and physical examination, prevention, screening, partner services, evaluation of STD-related conditions, laboratory, treatment, and referral to a specialist for complex STD or STD-related conditions.¹⁴ These recommendations can be used by providers, managers, advocates, and others working to implement the highest-quality STD clinical services. Below are key areas that can be addressed in ObGyn practice.

Continue to: Sexual history and physical examination...

Sexual history and physical examination

A complete sexual history and risk assessment should be performed at a complete initial or annual visit and as indicated. Routinely updating the sexual history and risk assessment is important to normalize these questions within the frame of the person’s overall health, and it may be valuable in reducing stigma. This routine approach may be important particularly for younger patients and others whose risk for STDs may change frequently and dramatically.

Creating a safe space that permits privacy and assurance of confidentiality may help build trust and set the stage for disclosure. The American College of Obstetricians and Gynecologists recommends that all young people have time alone without parents for confidential counseling and discussion.¹⁵ All states allow minors to consent for STD services themselves, although 11 states limit this to those beyond a certain age.¹⁶

The CDC recommends using the 5 P’s—partners, practices, protection, past history of STDs, and prevention of pregnancy—as a guide for discussion.¹⁴ ObGyns are more likely than other providers to perform this screening routinely. While a pelvic examination should be available for STD evaluation as needed, it is not required for routine screening.

Prevention

ObGyns should employ several recommendations for STD prevention. These include providing or referring patients for vaccination against hepatitis B and human papillomavirus and providing brief STD/HIV prevention counseling along with contraceptive counseling. ObGyns should be familiar with HIV pre-exposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP) and provide risk assessment, education, and referral or link to HIV care. Providing these services would improve access to care and further remove barriers to care. ObGyns also could consider providing condoms in their offices.¹⁴

Screening

STD screening of women at risk is critical since more than 80% of infected women are asymptomatic.⁸ Because young people are disproportionately experiencing STDs, annual screening for chlamydia and gonorrhea is recommended for women younger than 25 years. For women older than 25, those at increased risk can be screened.

Risk factors for chlamydia infection include having new or multiple sex partners, sex partners with concurrent partners, or sex partners who have an STD. For gonorrhea, risk factors include living in a high-morbidity area, having a previous or coexisting STD, new or multiple sex partners, inconsistent condom use in people who are not in a mutually monogamous relationship, and exchanging sex for money or drugs. Screening for syphilis in nonpregnant women is recommended for those who have had any sexual activity with a person recently diagnosed with syphilis or those who personally display signs or symptoms of infection.¹⁷

STD screening is especially important for pregnant women, and treatment of infections may improve pregnancy outcomes. The CDC recommends screening at the first prenatal care visit for chlamydia and gonorrhea in pregnant women younger than 25 years of age and in older pregnant women at increased risk; women younger than 25 years or at continued high risk should be rescreened in their third trimester. The CDC recommends screening all women for syphilis at their first prenatal care visit and rescreening those at high risk in the third trimester and at delivery (TABLE).¹⁸

Continue to: Partner services...

Partner services

Clearly outlined partner management services is paramount for preventing STD reinfection.¹⁴ Reinfection rates for chlamydia and gonorrhea among young women are high and vary by study population.¹⁹ At a minimum, ObGyns should counsel patients with an STD that their partner(s) should be notified and encouraged to seek services.

For states in which it is legal, expedited partner therapy (EPT)—the clinician provides medication for the partner without seeing the partner—should be provided for chlamydia or gonorrhea if the partner is unlikely to access timely care. EPT is legal in most states. (To check the legal status of EPT in your state, visit https://www.cdc.gov/std/ept/legal/default.htm.) Research is needed to evaluate optimal strategies for effective implementation of EPT services in different clinical settings.

Laboratory tests

ObGyns should be able to provide a wide range of laboratory evaluations (for example, a nucleic acid amplification test [NAAT] for genital chlamydia and gonorrhea, quantitative nontreponemal serologic test for syphilis, treponemal serologic test for syphilis) that can be ordered for screening or diagnostic purposes. To improve rates of recommended screening, consider having clinic-level policies that support screening, such as standing orders, express or walk-in screening appointments, lab panels, and reflex testing.

Further, having rapid results or point-of-care testing available would help decrease lags in time to treatment. Delays in treatment are particularly important in lower-resource communities; thus, point-of-care testing may be especially valuable with immediate access to treatment on site.

Treatment

Adequate and timely treatment of STDs is critical to decrease sequelae and the likelihood of transmission to others. Treatment is evolving, particularly for gonorrhea. Over the past several years, gonorrhea has become resistant to 6 previously recommended treatment options.²⁰ Since 2015, the CDC recommends dual therapy for gonorrhea with an injection of ceftriaxone and oral azithromycin.

The first-line recommended treatments for bacterial STDs are listed in the TABLE. When possible, it is preferred to offer directly observed therapy at the time of the visit. This decreases the time to treatment and ensures that therapy is completed.

A call to action for ObGyns

Clinicians have multiple opportunities to address and reduce the surge of STDs in the United States. We play a critical role in screening, diagnosing, and treating patients, and it is thus imperative to be up-to-date on the recommended guidelines. Further, clinicians can advocate for more rapid testing modalities, with the goal of obtaining point-of-care testing results when possible and implementing strategies to improve partner treatment.

While a positive STD result may be associated with significant patient distress, it also may be an opportunity for enhancing the patient-provider relationship, coupling education with motivational approaches to help patients increase protective health behaviors.

It is critical to approach clinical care in a nonjudgmental manner to improve patients’ comfort in their relationship with the health care system. ●

The sexually transmitted disease (STD) epidemic in the United States is intensifying, and it disproportionately impacts high-risk communities. In 2018, rates of reportable STDs, including syphilis and Neisseria gonorrhoeae and Chlamydia trachomatis infections, reached an all-time high.¹ That year, there were 1.8 million cases of chlamydia (increased 19% since 2014), 583,405 cases of gonorrhea (increased 63% since 2014), and 35,063 cases of primary and secondary syphilis (71% increase from 2014).¹

Cases of newborn syphilis have more than doubled in 4 years, with rates reaching a 20-year high.¹

This surge has not received the attention it deserves given the broad-reaching impact of these infections on women’s health and maternal-child health.² As ObGyns, we are on the front line, and we need to be engaged in evidence-based strategies and population-based health initiatives to expedite diagnoses and treatment and to reduce the ongoing spread of these infections.

Disparities exist and continue to fuel this epidemic

The STD burden is disproportionately high among reproductive-aged women, and half of all reported STDs occur in women aged 15 to 24 years. African American women have rates up to 12 times higher than white women.^3,4 Substantial geographic variability also exists, with the South, Southeast, and West having some of the highest STD rates.

These disparities are fueled by inequalities in socioeconomic status (SES), including employment, insurance, education, incarceration, stress/trauma exposure, and discrimination.^5-7 Those with lower SES often have trouble accessing and affording quality health care, including sexual health services. Access to quality health care, including STD prevention and treatment, that meets the needs of lower SES populations is key to reducing STD disparities in the United States; however, access likely will be insufficient unless the structural inequities that drive these disparities are addressed.

Clinical consequences for women, infants, and mothers

STDs are most prevalent among reproductive-aged women and can lead to pelvic inflammatory disease, infertility, ectopic pregnancy,^4,8 and increased risk of acquiring human immunodeficiency virus (HIV). STDs during pregnancy present additional consequences. Congenital syphilis is perhaps the most salient, with neonates experiencing substantial disability or death.

In addition, STDs contribute to overall peripartum and long-term adverse health outcomes.^4,9,10 Untreated chlamydia infection, for example, is associated with neonatal pneumonia, neonatal conjunctivitis, low birth weight, premature rupture of membranes, preterm labor, and postpartum endometritis.^2,11 Untreated gonorrhea is linked to disseminated gonococcal infection in the newborn, neonatal conjunctivitis, low birth weight, miscarriage, premature rupture of membranes, preterm labor, and chorioamnionitis.^2,12

As preterm birth is the leading cause of infant morbidity and mortality and disproportionately affects African American women and women in the southeastern United States,¹³ there is a critical public heath need to improve STD screening, treatment, and prevention of reinfection among high-risk pregnant women.

Quality clinical services for STDs: Areas for focus

More and more, STDs are being diagnosed in primary care settings. In January 2020, the Centers for Disease Control and Prevention (CDC) released a document, referred to as STD QCS (quality clinical services), that outlines recommendations for basic and specialty-level STD clinical services.¹⁴ ObGyns and other clinicians who provide primary care should meet the basic recommendations as a minimum.

The STD QCS outlines 8 recommendation areas: sexual history and physical examination, prevention, screening, partner services, evaluation of STD-related conditions, laboratory, treatment, and referral to a specialist for complex STD or STD-related conditions.¹⁴ These recommendations can be used by providers, managers, advocates, and others working to implement the highest-quality STD clinical services. Below are key areas that can be addressed in ObGyn practice.

Continue to: Sexual history and physical examination...

Sexual history and physical examination

A complete sexual history and risk assessment should be performed at a complete initial or annual visit and as indicated. Routinely updating the sexual history and risk assessment is important to normalize these questions within the frame of the person’s overall health, and it may be valuable in reducing stigma. This routine approach may be important particularly for younger patients and others whose risk for STDs may change frequently and dramatically.

Creating a safe space that permits privacy and assurance of confidentiality may help build trust and set the stage for disclosure. The American College of Obstetricians and Gynecologists recommends that all young people have time alone without parents for confidential counseling and discussion.¹⁵ All states allow minors to consent for STD services themselves, although 11 states limit this to those beyond a certain age.¹⁶

The CDC recommends using the 5 P’s—partners, practices, protection, past history of STDs, and prevention of pregnancy—as a guide for discussion.¹⁴ ObGyns are more likely than other providers to perform this screening routinely. While a pelvic examination should be available for STD evaluation as needed, it is not required for routine screening.

Prevention

ObGyns should employ several recommendations for STD prevention. These include providing or referring patients for vaccination against hepatitis B and human papillomavirus and providing brief STD/HIV prevention counseling along with contraceptive counseling. ObGyns should be familiar with HIV pre-exposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP) and provide risk assessment, education, and referral or link to HIV care. Providing these services would improve access to care and further remove barriers to care. ObGyns also could consider providing condoms in their offices.¹⁴

Screening

STD screening of women at risk is critical since more than 80% of infected women are asymptomatic.⁸ Because young people are disproportionately experiencing STDs, annual screening for chlamydia and gonorrhea is recommended for women younger than 25 years. For women older than 25, those at increased risk can be screened.

Risk factors for chlamydia infection include having new or multiple sex partners, sex partners with concurrent partners, or sex partners who have an STD. For gonorrhea, risk factors include living in a high-morbidity area, having a previous or coexisting STD, new or multiple sex partners, inconsistent condom use in people who are not in a mutually monogamous relationship, and exchanging sex for money or drugs. Screening for syphilis in nonpregnant women is recommended for those who have had any sexual activity with a person recently diagnosed with syphilis or those who personally display signs or symptoms of infection.¹⁷

STD screening is especially important for pregnant women, and treatment of infections may improve pregnancy outcomes. The CDC recommends screening at the first prenatal care visit for chlamydia and gonorrhea in pregnant women younger than 25 years of age and in older pregnant women at increased risk; women younger than 25 years or at continued high risk should be rescreened in their third trimester. The CDC recommends screening all women for syphilis at their first prenatal care visit and rescreening those at high risk in the third trimester and at delivery (TABLE).¹⁸

Continue to: Partner services...

Partner services

Clearly outlined partner management services is paramount for preventing STD reinfection.¹⁴ Reinfection rates for chlamydia and gonorrhea among young women are high and vary by study population.¹⁹ At a minimum, ObGyns should counsel patients with an STD that their partner(s) should be notified and encouraged to seek services.

For states in which it is legal, expedited partner therapy (EPT)—the clinician provides medication for the partner without seeing the partner—should be provided for chlamydia or gonorrhea if the partner is unlikely to access timely care. EPT is legal in most states. (To check the legal status of EPT in your state, visit https://www.cdc.gov/std/ept/legal/default.htm.) Research is needed to evaluate optimal strategies for effective implementation of EPT services in different clinical settings.

Laboratory tests

ObGyns should be able to provide a wide range of laboratory evaluations (for example, a nucleic acid amplification test [NAAT] for genital chlamydia and gonorrhea, quantitative nontreponemal serologic test for syphilis, treponemal serologic test for syphilis) that can be ordered for screening or diagnostic purposes. To improve rates of recommended screening, consider having clinic-level policies that support screening, such as standing orders, express or walk-in screening appointments, lab panels, and reflex testing.

Further, having rapid results or point-of-care testing available would help decrease lags in time to treatment. Delays in treatment are particularly important in lower-resource communities; thus, point-of-care testing may be especially valuable with immediate access to treatment on site.

Treatment

Adequate and timely treatment of STDs is critical to decrease sequelae and the likelihood of transmission to others. Treatment is evolving, particularly for gonorrhea. Over the past several years, gonorrhea has become resistant to 6 previously recommended treatment options.²⁰ Since 2015, the CDC recommends dual therapy for gonorrhea with an injection of ceftriaxone and oral azithromycin.

The first-line recommended treatments for bacterial STDs are listed in the TABLE. When possible, it is preferred to offer directly observed therapy at the time of the visit. This decreases the time to treatment and ensures that therapy is completed.

A call to action for ObGyns

Clinicians have multiple opportunities to address and reduce the surge of STDs in the United States. We play a critical role in screening, diagnosing, and treating patients, and it is thus imperative to be up-to-date on the recommended guidelines. Further, clinicians can advocate for more rapid testing modalities, with the goal of obtaining point-of-care testing results when possible and implementing strategies to improve partner treatment.

While a positive STD result may be associated with significant patient distress, it also may be an opportunity for enhancing the patient-provider relationship, coupling education with motivational approaches to help patients increase protective health behaviors.

It is critical to approach clinical care in a nonjudgmental manner to improve patients’ comfort in their relationship with the health care system. ●

Authors of a recent Cochrane review concluded that low-dose aspirin treatment of 1,000 pregnant women at risk of developing preeclampsia resulted in 16 fewer cases of preeclampsia, 16 fewer preterm births, 7 fewer cases of small-for-gestational age newborns, and 5 fewer fetal or neonatal deaths.¹

The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) recommend treatment with 81 mg of aspirin daily, initiated before 16 weeks of pregnancy to prevent preeclampsia in women with one major risk factor (personal history of preeclampsia, multifetal gestation, chronic hypertension, type 1 or 2 diabetes, renal or autoimmune disease) or at least two moderate risk factors (nulliparity; obesity; mother or sister with preeclampsia; a sociodemographic characteristic such as African American race or low socioeconomic status; age ≥35 years; personal history factors such as prior low birth weight infant, previous adverse pregnancy outcome, or >10-year interpregnancy interval).^2,3 Healthy pregnant women with a previous uncomplicated full-term delivery do not need treatment with low-dose aspirin.^2,3

However, evolving data and expert opinion suggest that expanding the indications for aspirin treatment and increasing the recommended dose of aspirin may be warranted. 

Nulliparity

Nulliparity is the single clinical characteristic that is associated with the greatest number of cases of preeclampsia.⁴ Hence, from a public health perspective, reducing the rate of preeclampsia among nulliparous women is a top priority.

ACOG and USPSTF do not recommend aspirin treatment for all nulliparous women because risk factors help to identify those nulliparous women who benefit from aspirin treatment.

However, a recent cost-effectiveness analysis compared the health care costs and rates of preeclampsia for 4 prevention strategies among all pregnant women in the United States (nulliparous and parous)⁵:

1. no aspirin use
2. use of aspirin based on biomarker and ultrasound measurements
3. use of aspirin based on USPSTF guidelines for identifying women at risk
4. prescription of aspirin to all pregnant women.

Health care costs and rates of preeclampsia were lowest with the universal prescription of aspirin to all pregnant women in the United States. Compared with universal prescription of aspirin, the USPSTF approach, the biomarker-ultrasound approach, and the no aspirin approach were associated with 346, 308, and 762 additional cases of preeclampsia per 100,000 women. In sensitivity analyses, universal aspirin was the optimal strategy under most assumptions.

Another cost effectiveness analysis concluded that among nulliparous pregnant women, universal aspirin treatment was superior to aspirin treatment based on biomarker-ultrasound identification of women at high risk.⁶ 

In a recent clinical trial performed in India, Guatemala, Pakistan, Democratic Republic of Congo, Kenya, and Zambia, 14,361 nulliparous women were randomly assigned to placebo or 81 mg of aspirin daily between 6 and 14 weeks of gestation.⁷ Preterm birth (<37 weeks’ gestation) occurred in 13.1% and 11.6% of women treated with placebo or aspirin (relative risk [RR], 0.89; 95% confidence interval [CI], 0.81 to 0.98, P = .012). Most of the decrease in preterm birth appeared to be due to a decrease in the rate of preeclampsia in the aspirin-treated nulliparous women. The investigators also noted that aspirin treatment of nulliparous women resulted in a statistically significant decrease in perinatal mortality (RR, 0.86) and early preterm delivery, <34 weeks’ gestation (RR, 0.75). 

Universal prescription of low-dose aspirin to nulliparous women in order to prevent preeclampsia and preterm birth may become recognized as an optimal public health strategy. As a step toward universal prescription of aspirin to nulliparous women, an opt-out rather than a screen-in strategy might be considered.⁸

Continue to: Booking systolic blood pressure, 120 to 134 mm Hg...

Booking systolic blood pressure, 120 to 134 mm Hg

All obstetricians recognize that women with chronic hypertension should be treated with low-dose aspirin because they are at high risk for preeclampsia. However, there is evidence that nulliparous women with a booking systolic pressure ≥120 mm Hg might also benefit from low-dose aspirin treatment. In one US trial, 3,135 nulliparous normotensive women (booking blood pressure [BP] <135/85 mm Hg) were randomly assigned to treatment with aspirin (60 mg daily) or placebo initiated between 13 and 26 weeks’ gestation. Preeclampsia occurred in 6.3% and 4.6% of the women treated with placebo or aspirin, respectively (RR, 0.7; 95% CI, 0.6–1.0; P = .05).⁹ A secondary analysis showed that, among 519 nulliparous women with a booking systolic BP from 120 to 134 mm Hg, compared with placebo, low-dose aspirin treatment reduced the rate of preeclampsia from 11.9% to 5.6%.⁹ Aspirin did not reduce the rate of preeclampsia among nulliparous women with a booking systolic BP <120 mm Hg.⁹ A systematic review of risk factors for developing preeclampsia reported that a booking diastolic BP of ≥80 mm Hg was associated with an increased risk of developing preeclampsia (RR, 1.38).¹⁰ 

The American Heart Association (AHA) and the American College of Cardiology (ACC) recently updated the definition of hypertension.¹¹ Normal BP is now defined as a systolic pressure <120 mm Hg and diastolic pressure <80 mm Hg. Elevated BP is a systolic pressure of 120 to 129 mm Hg and diastolic pressure of <80 mm Hg. Stage I hypertension is a systolic BP from 130 to 139 mm Hg or diastolic blood pressure from 80 to 89 mm Hg. Stage II hypertension is a systolic BP of ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg.¹¹ 

A recent study reported that 90% of women at 12 weeks’ gestation have a BP of ≤130 mm Hg systolic and ≤80 mm Hg diastolic, suggesting that the AHA-ACC criteria for stage I hypertension are reasonable.¹² Obstetricians have not yet fully adopted the AHA-ACC criteria for defining stage I hypertension in pregnant women. Future research may demonstrate that a booking systolic BP 
 ≥130 mm Hg or a diastolic BP ≥80 mm Hg are major risk factors for developing preeclampsia and warrant treatment with low-dose aspirin.

Continue to: Pregnancy resulting from fertility therapy...

Pregnancy resulting from fertility therapy

Current ACOG and USPSTF guidelines do not specifically identify pregnancies resulting from assisted reproductive technology as a major or moderate risk factor for preeclampsia.^2,3 In a study comparing 83,582 births resulting from in vitro fertilization (IVF) and 1,382,311 births to fertile women, treatment with autologous cryopreserved embryos (adjusted odds ratio [aOR], 1.30), fresh donor embryos (aOR, 1.92), and cryopreserved donor embryos (aOR, 1.70) significantly increased the risk of preeclampsia.¹³ However, use of fresh autologous embryos did not increase the risk of preeclampsia (aOR, 1.04). These associations persisted after controlling for diabetes, hypertension, body mass index, and cause of infertility.¹³

Other studies also have reported that use of cryopreserved embryos is associated with a higher rate of preeclampsia than use of fresh autologous embryos. In a study of 825 infertile women undergoing IVF and randomly assigned to single embryo cryopreserved or fresh cycles, the rate of preeclampsia was 3.1% and 1.0% in the pregnancies that resulted from cryopreserved versus fresh cycles.¹⁴ 

What is the optimal dose of aspirin?

ACOG and the USPSTF recommend aspirin 81 mg daily for the prevention of preeclampsia.^2,3 The International Federation of Gynecology and Obstetrics (FIGO) recommends aspirin 150 mg daily for the prevention of preeclampsia.¹⁵ The FIGO recommendation is based, in part, on the results of a large international clinical trial that randomly assigned 1,776 women at high risk for preeclampsia as determined by clinical factors plus biomarker and ultrasound screening to receive aspirin 150 mg daily or placebo daily initiated at 11 to 14 weeks’ gestation and continued until 36 weeks’ gestation.¹⁶ Preeclampsia before 37 weeks’ gestation occurred in 4.3% and 1.6% of women in the placebo and aspirin groups (OR, 0.38; 95% CI, 0.20–0.74; P = .004).¹⁶ FIGO recommends that women at risk for preeclampsia with a body mass <40 kg take aspirin 100 mg daily and women with a body mass ≥40 kg take aspirin at a dose of 150 mg daily. For women who live in a country where aspirin is not available in a pill containing 150 mg, FIGO recommends taking two 81 mg tablets.¹⁵ FIGO recommends initiating aspirin between 11 and 14 weeks and 6 days of gestation and continuing aspirin therapy until 36 weeks of gestation.¹⁵

Aspirin is an inexpensive intervention with many possible benefits

For many nulliparous women and some parous women aspirin treatment initiated early in pregnancy will improve maternal and newborn outcomes, including reducing the risk of preeclampsia, preterm birth, and intrauterine growth restriction.¹ Obstetricians may want to begin to expand the indications for offering aspirin to prevent preeclampsia from those recommended by ACOG and the USPSTF to include nulliparous women with a booking systolic pressure of 120 to 134 mm Hg and women whose pregnancy was the result of an assisted reproduction treatment that used cryopreserved embryos. In addition, obstetricians who currently prescribe 81 mg of aspirin daily might want to consider increasing the prescribed dose to 162 mg of aspirin daily (two 81 mg tablets daily or one-half of a 325 mg tablet). Aspirin costs about less than 5 cents per 81 mg tablet (according to GoodRx website). It is an inexpensive intervention that could benefit many mothers and newborns. ●

Authors of a recent Cochrane review concluded that low-dose aspirin treatment of 1,000 pregnant women at risk of developing preeclampsia resulted in 16 fewer cases of preeclampsia, 16 fewer preterm births, 7 fewer cases of small-for-gestational age newborns, and 5 fewer fetal or neonatal deaths.¹

The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) recommend treatment with 81 mg of aspirin daily, initiated before 16 weeks of pregnancy to prevent preeclampsia in women with one major risk factor (personal history of preeclampsia, multifetal gestation, chronic hypertension, type 1 or 2 diabetes, renal or autoimmune disease) or at least two moderate risk factors (nulliparity; obesity; mother or sister with preeclampsia; a sociodemographic characteristic such as African American race or low socioeconomic status; age ≥35 years; personal history factors such as prior low birth weight infant, previous adverse pregnancy outcome, or >10-year interpregnancy interval).^2,3 Healthy pregnant women with a previous uncomplicated full-term delivery do not need treatment with low-dose aspirin.^2,3

However, evolving data and expert opinion suggest that expanding the indications for aspirin treatment and increasing the recommended dose of aspirin may be warranted. 

Nulliparity

Nulliparity is the single clinical characteristic that is associated with the greatest number of cases of preeclampsia.⁴ Hence, from a public health perspective, reducing the rate of preeclampsia among nulliparous women is a top priority.

ACOG and USPSTF do not recommend aspirin treatment for all nulliparous women because risk factors help to identify those nulliparous women who benefit from aspirin treatment.

However, a recent cost-effectiveness analysis compared the health care costs and rates of preeclampsia for 4 prevention strategies among all pregnant women in the United States (nulliparous and parous)⁵:

1. no aspirin use
2. use of aspirin based on biomarker and ultrasound measurements
3. use of aspirin based on USPSTF guidelines for identifying women at risk
4. prescription of aspirin to all pregnant women.

Health care costs and rates of preeclampsia were lowest with the universal prescription of aspirin to all pregnant women in the United States. Compared with universal prescription of aspirin, the USPSTF approach, the biomarker-ultrasound approach, and the no aspirin approach were associated with 346, 308, and 762 additional cases of preeclampsia per 100,000 women. In sensitivity analyses, universal aspirin was the optimal strategy under most assumptions.

Another cost effectiveness analysis concluded that among nulliparous pregnant women, universal aspirin treatment was superior to aspirin treatment based on biomarker-ultrasound identification of women at high risk.⁶ 

In a recent clinical trial performed in India, Guatemala, Pakistan, Democratic Republic of Congo, Kenya, and Zambia, 14,361 nulliparous women were randomly assigned to placebo or 81 mg of aspirin daily between 6 and 14 weeks of gestation.⁷ Preterm birth (<37 weeks’ gestation) occurred in 13.1% and 11.6% of women treated with placebo or aspirin (relative risk [RR], 0.89; 95% confidence interval [CI], 0.81 to 0.98, P = .012). Most of the decrease in preterm birth appeared to be due to a decrease in the rate of preeclampsia in the aspirin-treated nulliparous women. The investigators also noted that aspirin treatment of nulliparous women resulted in a statistically significant decrease in perinatal mortality (RR, 0.86) and early preterm delivery, <34 weeks’ gestation (RR, 0.75). 

Universal prescription of low-dose aspirin to nulliparous women in order to prevent preeclampsia and preterm birth may become recognized as an optimal public health strategy. As a step toward universal prescription of aspirin to nulliparous women, an opt-out rather than a screen-in strategy might be considered.⁸

Continue to: Booking systolic blood pressure, 120 to 134 mm Hg...

Booking systolic blood pressure, 120 to 134 mm Hg

All obstetricians recognize that women with chronic hypertension should be treated with low-dose aspirin because they are at high risk for preeclampsia. However, there is evidence that nulliparous women with a booking systolic pressure ≥120 mm Hg might also benefit from low-dose aspirin treatment. In one US trial, 3,135 nulliparous normotensive women (booking blood pressure [BP] <135/85 mm Hg) were randomly assigned to treatment with aspirin (60 mg daily) or placebo initiated between 13 and 26 weeks’ gestation. Preeclampsia occurred in 6.3% and 4.6% of the women treated with placebo or aspirin, respectively (RR, 0.7; 95% CI, 0.6–1.0; P = .05).⁹ A secondary analysis showed that, among 519 nulliparous women with a booking systolic BP from 120 to 134 mm Hg, compared with placebo, low-dose aspirin treatment reduced the rate of preeclampsia from 11.9% to 5.6%.⁹ Aspirin did not reduce the rate of preeclampsia among nulliparous women with a booking systolic BP <120 mm Hg.⁹ A systematic review of risk factors for developing preeclampsia reported that a booking diastolic BP of ≥80 mm Hg was associated with an increased risk of developing preeclampsia (RR, 1.38).¹⁰ 

The American Heart Association (AHA) and the American College of Cardiology (ACC) recently updated the definition of hypertension.¹¹ Normal BP is now defined as a systolic pressure <120 mm Hg and diastolic pressure <80 mm Hg. Elevated BP is a systolic pressure of 120 to 129 mm Hg and diastolic pressure of <80 mm Hg. Stage I hypertension is a systolic BP from 130 to 139 mm Hg or diastolic blood pressure from 80 to 89 mm Hg. Stage II hypertension is a systolic BP of ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg.¹¹ 

A recent study reported that 90% of women at 12 weeks’ gestation have a BP of ≤130 mm Hg systolic and ≤80 mm Hg diastolic, suggesting that the AHA-ACC criteria for stage I hypertension are reasonable.¹² Obstetricians have not yet fully adopted the AHA-ACC criteria for defining stage I hypertension in pregnant women. Future research may demonstrate that a booking systolic BP 
 ≥130 mm Hg or a diastolic BP ≥80 mm Hg are major risk factors for developing preeclampsia and warrant treatment with low-dose aspirin.

Continue to: Pregnancy resulting from fertility therapy...

Pregnancy resulting from fertility therapy

Current ACOG and USPSTF guidelines do not specifically identify pregnancies resulting from assisted reproductive technology as a major or moderate risk factor for preeclampsia.^2,3 In a study comparing 83,582 births resulting from in vitro fertilization (IVF) and 1,382,311 births to fertile women, treatment with autologous cryopreserved embryos (adjusted odds ratio [aOR], 1.30), fresh donor embryos (aOR, 1.92), and cryopreserved donor embryos (aOR, 1.70) significantly increased the risk of preeclampsia.¹³ However, use of fresh autologous embryos did not increase the risk of preeclampsia (aOR, 1.04). These associations persisted after controlling for diabetes, hypertension, body mass index, and cause of infertility.¹³

Other studies also have reported that use of cryopreserved embryos is associated with a higher rate of preeclampsia than use of fresh autologous embryos. In a study of 825 infertile women undergoing IVF and randomly assigned to single embryo cryopreserved or fresh cycles, the rate of preeclampsia was 3.1% and 1.0% in the pregnancies that resulted from cryopreserved versus fresh cycles.¹⁴ 

What is the optimal dose of aspirin?

ACOG and the USPSTF recommend aspirin 81 mg daily for the prevention of preeclampsia.^2,3 The International Federation of Gynecology and Obstetrics (FIGO) recommends aspirin 150 mg daily for the prevention of preeclampsia.¹⁵ The FIGO recommendation is based, in part, on the results of a large international clinical trial that randomly assigned 1,776 women at high risk for preeclampsia as determined by clinical factors plus biomarker and ultrasound screening to receive aspirin 150 mg daily or placebo daily initiated at 11 to 14 weeks’ gestation and continued until 36 weeks’ gestation.¹⁶ Preeclampsia before 37 weeks’ gestation occurred in 4.3% and 1.6% of women in the placebo and aspirin groups (OR, 0.38; 95% CI, 0.20–0.74; P = .004).¹⁶ FIGO recommends that women at risk for preeclampsia with a body mass <40 kg take aspirin 100 mg daily and women with a body mass ≥40 kg take aspirin at a dose of 150 mg daily. For women who live in a country where aspirin is not available in a pill containing 150 mg, FIGO recommends taking two 81 mg tablets.¹⁵ FIGO recommends initiating aspirin between 11 and 14 weeks and 6 days of gestation and continuing aspirin therapy until 36 weeks of gestation.¹⁵

Aspirin is an inexpensive intervention with many possible benefits

For many nulliparous women and some parous women aspirin treatment initiated early in pregnancy will improve maternal and newborn outcomes, including reducing the risk of preeclampsia, preterm birth, and intrauterine growth restriction.¹ Obstetricians may want to begin to expand the indications for offering aspirin to prevent preeclampsia from those recommended by ACOG and the USPSTF to include nulliparous women with a booking systolic pressure of 120 to 134 mm Hg and women whose pregnancy was the result of an assisted reproduction treatment that used cryopreserved embryos. In addition, obstetricians who currently prescribe 81 mg of aspirin daily might want to consider increasing the prescribed dose to 162 mg of aspirin daily (two 81 mg tablets daily or one-half of a 325 mg tablet). Aspirin costs about less than 5 cents per 81 mg tablet (according to GoodRx website). It is an inexpensive intervention that could benefit many mothers and newborns. ●

Authors of a recent Cochrane review concluded that low-dose aspirin treatment of 1,000 pregnant women at risk of developing preeclampsia resulted in 16 fewer cases of preeclampsia, 16 fewer preterm births, 7 fewer cases of small-for-gestational age newborns, and 5 fewer fetal or neonatal deaths.¹

The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) recommend treatment with 81 mg of aspirin daily, initiated before 16 weeks of pregnancy to prevent preeclampsia in women with one major risk factor (personal history of preeclampsia, multifetal gestation, chronic hypertension, type 1 or 2 diabetes, renal or autoimmune disease) or at least two moderate risk factors (nulliparity; obesity; mother or sister with preeclampsia; a sociodemographic characteristic such as African American race or low socioeconomic status; age ≥35 years; personal history factors such as prior low birth weight infant, previous adverse pregnancy outcome, or >10-year interpregnancy interval).^2,3 Healthy pregnant women with a previous uncomplicated full-term delivery do not need treatment with low-dose aspirin.^2,3

However, evolving data and expert opinion suggest that expanding the indications for aspirin treatment and increasing the recommended dose of aspirin may be warranted. 

Nulliparity

Nulliparity is the single clinical characteristic that is associated with the greatest number of cases of preeclampsia.⁴ Hence, from a public health perspective, reducing the rate of preeclampsia among nulliparous women is a top priority.

ACOG and USPSTF do not recommend aspirin treatment for all nulliparous women because risk factors help to identify those nulliparous women who benefit from aspirin treatment.

However, a recent cost-effectiveness analysis compared the health care costs and rates of preeclampsia for 4 prevention strategies among all pregnant women in the United States (nulliparous and parous)⁵:

1. no aspirin use
2. use of aspirin based on biomarker and ultrasound measurements
3. use of aspirin based on USPSTF guidelines for identifying women at risk
4. prescription of aspirin to all pregnant women.

Health care costs and rates of preeclampsia were lowest with the universal prescription of aspirin to all pregnant women in the United States. Compared with universal prescription of aspirin, the USPSTF approach, the biomarker-ultrasound approach, and the no aspirin approach were associated with 346, 308, and 762 additional cases of preeclampsia per 100,000 women. In sensitivity analyses, universal aspirin was the optimal strategy under most assumptions.

Another cost effectiveness analysis concluded that among nulliparous pregnant women, universal aspirin treatment was superior to aspirin treatment based on biomarker-ultrasound identification of women at high risk.⁶ 

In a recent clinical trial performed in India, Guatemala, Pakistan, Democratic Republic of Congo, Kenya, and Zambia, 14,361 nulliparous women were randomly assigned to placebo or 81 mg of aspirin daily between 6 and 14 weeks of gestation.⁷ Preterm birth (<37 weeks’ gestation) occurred in 13.1% and 11.6% of women treated with placebo or aspirin (relative risk [RR], 0.89; 95% confidence interval [CI], 0.81 to 0.98, P = .012). Most of the decrease in preterm birth appeared to be due to a decrease in the rate of preeclampsia in the aspirin-treated nulliparous women. The investigators also noted that aspirin treatment of nulliparous women resulted in a statistically significant decrease in perinatal mortality (RR, 0.86) and early preterm delivery, <34 weeks’ gestation (RR, 0.75). 

Universal prescription of low-dose aspirin to nulliparous women in order to prevent preeclampsia and preterm birth may become recognized as an optimal public health strategy. As a step toward universal prescription of aspirin to nulliparous women, an opt-out rather than a screen-in strategy might be considered.⁸

Continue to: Booking systolic blood pressure, 120 to 134 mm Hg...

Booking systolic blood pressure, 120 to 134 mm Hg

All obstetricians recognize that women with chronic hypertension should be treated with low-dose aspirin because they are at high risk for preeclampsia. However, there is evidence that nulliparous women with a booking systolic pressure ≥120 mm Hg might also benefit from low-dose aspirin treatment. In one US trial, 3,135 nulliparous normotensive women (booking blood pressure [BP] <135/85 mm Hg) were randomly assigned to treatment with aspirin (60 mg daily) or placebo initiated between 13 and 26 weeks’ gestation. Preeclampsia occurred in 6.3% and 4.6% of the women treated with placebo or aspirin, respectively (RR, 0.7; 95% CI, 0.6–1.0; P = .05).⁹ A secondary analysis showed that, among 519 nulliparous women with a booking systolic BP from 120 to 134 mm Hg, compared with placebo, low-dose aspirin treatment reduced the rate of preeclampsia from 11.9% to 5.6%.⁹ Aspirin did not reduce the rate of preeclampsia among nulliparous women with a booking systolic BP <120 mm Hg.⁹ A systematic review of risk factors for developing preeclampsia reported that a booking diastolic BP of ≥80 mm Hg was associated with an increased risk of developing preeclampsia (RR, 1.38).¹⁰ 

The American Heart Association (AHA) and the American College of Cardiology (ACC) recently updated the definition of hypertension.¹¹ Normal BP is now defined as a systolic pressure <120 mm Hg and diastolic pressure <80 mm Hg. Elevated BP is a systolic pressure of 120 to 129 mm Hg and diastolic pressure of <80 mm Hg. Stage I hypertension is a systolic BP from 130 to 139 mm Hg or diastolic blood pressure from 80 to 89 mm Hg. Stage II hypertension is a systolic BP of ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg.¹¹ 

A recent study reported that 90% of women at 12 weeks’ gestation have a BP of ≤130 mm Hg systolic and ≤80 mm Hg diastolic, suggesting that the AHA-ACC criteria for stage I hypertension are reasonable.¹² Obstetricians have not yet fully adopted the AHA-ACC criteria for defining stage I hypertension in pregnant women. Future research may demonstrate that a booking systolic BP 
 ≥130 mm Hg or a diastolic BP ≥80 mm Hg are major risk factors for developing preeclampsia and warrant treatment with low-dose aspirin.

Continue to: Pregnancy resulting from fertility therapy...

Pregnancy resulting from fertility therapy

Current ACOG and USPSTF guidelines do not specifically identify pregnancies resulting from assisted reproductive technology as a major or moderate risk factor for preeclampsia.^2,3 In a study comparing 83,582 births resulting from in vitro fertilization (IVF) and 1,382,311 births to fertile women, treatment with autologous cryopreserved embryos (adjusted odds ratio [aOR], 1.30), fresh donor embryos (aOR, 1.92), and cryopreserved donor embryos (aOR, 1.70) significantly increased the risk of preeclampsia.¹³ However, use of fresh autologous embryos did not increase the risk of preeclampsia (aOR, 1.04). These associations persisted after controlling for diabetes, hypertension, body mass index, and cause of infertility.¹³

Other studies also have reported that use of cryopreserved embryos is associated with a higher rate of preeclampsia than use of fresh autologous embryos. In a study of 825 infertile women undergoing IVF and randomly assigned to single embryo cryopreserved or fresh cycles, the rate of preeclampsia was 3.1% and 1.0% in the pregnancies that resulted from cryopreserved versus fresh cycles.¹⁴ 

What is the optimal dose of aspirin?

ACOG and the USPSTF recommend aspirin 81 mg daily for the prevention of preeclampsia.^2,3 The International Federation of Gynecology and Obstetrics (FIGO) recommends aspirin 150 mg daily for the prevention of preeclampsia.¹⁵ The FIGO recommendation is based, in part, on the results of a large international clinical trial that randomly assigned 1,776 women at high risk for preeclampsia as determined by clinical factors plus biomarker and ultrasound screening to receive aspirin 150 mg daily or placebo daily initiated at 11 to 14 weeks’ gestation and continued until 36 weeks’ gestation.¹⁶ Preeclampsia before 37 weeks’ gestation occurred in 4.3% and 1.6% of women in the placebo and aspirin groups (OR, 0.38; 95% CI, 0.20–0.74; P = .004).¹⁶ FIGO recommends that women at risk for preeclampsia with a body mass <40 kg take aspirin 100 mg daily and women with a body mass ≥40 kg take aspirin at a dose of 150 mg daily. For women who live in a country where aspirin is not available in a pill containing 150 mg, FIGO recommends taking two 81 mg tablets.¹⁵ FIGO recommends initiating aspirin between 11 and 14 weeks and 6 days of gestation and continuing aspirin therapy until 36 weeks of gestation.¹⁵

Aspirin is an inexpensive intervention with many possible benefits

For many nulliparous women and some parous women aspirin treatment initiated early in pregnancy will improve maternal and newborn outcomes, including reducing the risk of preeclampsia, preterm birth, and intrauterine growth restriction.¹ Obstetricians may want to begin to expand the indications for offering aspirin to prevent preeclampsia from those recommended by ACOG and the USPSTF to include nulliparous women with a booking systolic pressure of 120 to 134 mm Hg and women whose pregnancy was the result of an assisted reproduction treatment that used cryopreserved embryos. In addition, obstetricians who currently prescribe 81 mg of aspirin daily might want to consider increasing the prescribed dose to 162 mg of aspirin daily (two 81 mg tablets daily or one-half of a 325 mg tablet). Aspirin costs about less than 5 cents per 81 mg tablet (according to GoodRx website). It is an inexpensive intervention that could benefit many mothers and newborns. ●

CASE Young woman with discharge from one nipple

A 26-year-old African American woman pre­sents with a 10-month history of left nipple discharge. The patient describes the discharge as spontaneous, colored dark brown to yellow, and occurring from a single opening in the nipple. The discharge is associated with left breast pain and fullness, without a palpable lump. The patient has no family or personal history of breast cancer.

Nipple discharge is the third most common breast-related symptom (after palpable masses and breast pain), with an estimated prevalence of 5% to 8% among premenopausal women.¹ While most causes of nipple discharge reflect benign issues, approximately 5% to 12% of breast cancers have nipple discharge as the only symptom.² Not surprisingly, nipple discharge creates anxiety for both patients and clinicians.

In this article, we—a breast imaging radiologist, gynecologist, and breast surgeon—outline key steps for evaluating and managing patients with nipple discharge.

Two types of nipple discharge

Nipple discharge can be characterized as physiologic or pathologic. The distinction is based on the patient’s history in conjunction with the clinical breast exam.

Physiologic nipple discharge often is bilateral, nonspontaneous, and white, yellow, green, or brown (TABLE).³ It often is due to nipple stimulation, and the patient can elicit discharge by manually manipulating the breast. Usually, multiple ducts are involved. Galactorrhea refers specifically to milky discharge and occurs most commonly during pregnancy or lactation.² Galactorrhea that is not associated with pregnancy or lactation often is related to elevated prolactin or thyroid-stimulating hormone levels or to medications. One study reported that no cancers were found when discharge was nonspontaneous and colored or milky.⁴

Pathologic nipple discharge is defined as a spontaneous, bloody, clear, or single-duct discharge. A palpable mass in the same breast automatically increases the suspicion of the discharge, regardless of its color or spontaneity.² The most common cause of pathologic nipple discharge is an intraductal papilloma, a benign epithelial tumor, which accounts for approximately 57% of cases.⁵

Although the risk of malignancy is low for all patients with nipple discharge, increasing age is associated with increased risk of breast cancer. One study demonstrated that among women aged 40 to 60 years presenting with nipple discharge, the prevalence of invasive cancer is 10%, and the percentage jumps to 32% among women older than 60.⁶

Breast exam. For any patient with nonlactational nipple discharge, we recommend a thorough breast examination. Deep palpation of all quadrants of the symptomatic breast, especially near the nipple areolar complex, should elicit nipple discharge without any direct squeezing of the nipple. If the patient’s history and physical exam are consistent with physiologic discharge, no further workup is needed. Reassure the patient and recommend appropriate breast cancer screening. Encourage the patient to decrease stimulation or manual manipulation of the nipples if the discharge bothers her.

Continue to: CASE Continued: Workup...

CASE Continued: Workup

On physical exam, the patient’s breasts are noted to be cup size DDD and asymmetric, with the left breast larger than the right; there is no contour deformity. There is no skin or nipple retraction, skin rash, swelling, or nipple changes bilaterally. No dominant masses are appreciated bilaterally. Manual compression elicits no nipple discharge.

Although the discharge is nonbloody, its spontaneity, unilaterality, and single-duct/orifice origin suggest a pathologic cause. The patient is referred for breast imaging.

Imaging workup for pathologic discharge

The American College of Radiology (ACR) Appropriateness Criteria is a useful tool that provides an evidence-based, easy-to-use algorithm for breast imaging in the patient with pathologic nipple discharge (FIGURE 1).⁶ The algorithm is categorized by patient age, with diagnostic mammography recommended for women aged 30 and older.⁶ Diagnostic mammography is recommended if the patient has not had a mammogram study in the last 6 months.⁶ For patients with no prior mammograms, we recommend bilateral diagnostic mammography to compare symmetry of the breasts.

Currently, no studies show that digital breast tomosynthesis (3-D mammography) has a benefit compared with standard 2-D mammography in women with pathologic nipple discharge.⁶ Given the increased sensitivity of digital breast tomosynthesis for cancer detection, however, in our practice it is standard to use tomosynthesis in the diagnostic evaluation of most patients.

Mammography

On mammography, ductal carcinoma in situ (DCIS) usually presents as calcifications. Both the morphology and distribution of calcifications are used to characterize them as suspicious or, typically, benign. DCIS usually presents as fine pleomorphic or fine linear branching calcifications in a segmental or linear distribution. In patients with pathologic nipple discharge and no other symptoms, the radiologist must closely examine the retroareolar region of the breast to assess for faint calcifications. Magnification views also can be performed to better characterize calcifications.

The sensitivity of mammography for nipple discharge varies in the literature, ranging from approximately 15% to 68%, with a specificity range of 38% to 98%.⁶ This results in a relatively low positive predictive value but a high negative predictive value of 90%.⁷ Mammographic sensitivity largely is limited by increased breast density. As more data emerge on the utility of digital breast tomosynthesis in dense breasts, mammographic sensitivity for nipple discharge will likely increase.

Ultrasonography

As an adjunct to mammography, the ACR Appropriateness Criteria recommends targeted (or “limited”) ultrasonography of the retroareolar region of the affected breast for patients aged 30 and older. Ultrasonography is useful to assess for intraductal masses and architectural distortion, and it has higher sensitivity but lower specificity than mammography. The sensitivity of ultrasonography for detecting breast cancer in patients presenting with nipple discharge is reported to be 56% to 80%.⁶ Ultrasonography can identify lesions not visible mammographically in 63% to 69% of cases.⁸ Although DCIS usually presents as calcifications, it also can present as an intraductal mass on ultrasonography.

The ACR recommends targeted ultrasonography for patients with nipple discharge and a negative mammogram, or to evaluate a suspicious mammographic abnormality such as architectural distortion, focal asymmetry, or a mass.⁶ For patient comfort, ultrasonography is the preferred modality for image-guided biopsy.

For women younger than 30 years, targeted ultrasonography is the initial imaging study of choice, according to the ACR criteria.⁶ Women younger than 30 years with pathologic nipple discharge have a very low risk of breast cancer and tend to have higher breast density, making mammography less useful. Although the radiation dose from mammography is negligible given technological improvements and dose-reduction techniques, ultrasonography remains the preferred initial imaging modality in young women, not only for nipple discharge but also for palpable lumps and focal breast pain.

Mammography is used as an adjunct to ultrasonography in women younger than 30 years when a suspicious abnormality is detected on ultrasonography, such as an intraductal mass or architectural distortion. In these cases, mammography can be used to assess for extent of disease or to visualize suspicious calcifications not well seen on ultrasonography.

For practical purposes regarding which imaging study to order for a patient, it is most efficient to order both a diagnostic mammogram (with tomosynthesis, if possible) and a targeted ultrasound scan of the affected breast. Even if both orders are not needed, having them available increases efficiency for both the radiologist and the ordering physician.

Continue to: CASE Continued: Imaging findings...

CASE Continued: Imaging findings

Given her age, the patient initially undergoes targeted ultrasonography. The grayscale image (FIGURE 2) demonstrates multiple mildly dilated ducts (white arrows) with surrounding hyperechogenicity of the fat (red arrows), indicating soft tissue edema. No intraductal mass is imaged. Given that the ultrasonography findings are not completely negative and are equivocal for malignancy, bilateral diagnostic mammography (FIGURE 3, left breast only) is performed. Standard full-field craniocaudal (FIGURE 3A) and mediolateral oblique (FIGURE 3B) mammographic views demonstrate a heterogeneously dense breast with a few calcifications in the retroareolar left breast (red ovals). No associated mass or architectural distortions are noted. The mammographic and sonographic findings do not reveal a definitive biopsy target.

Ductography

When a suspicious abnormality is visualized on either mammography or ultrasonography, the standard of care is to perform an image-guided biopsy of the abnormality. When the standard workup is negative or equivocal, the standard of care historically was to perform ductography.

Ductography is an invasive procedure that involves cannulating the suspicious duct with a small catheter and injecting radiopaque dye into the duct under mammographic guidance. While the sensitivity of ductography is higher than that of both mammography and ultrasonography, its specificity is lower than that of either modality.

Most cases of pathologic discharge are spontaneous and are not reproducible on the day of the procedure. If the procedural radiologist cannot visualize the duct that is producing the discharge, the procedure cannot be performed. Although most patients tolerate the procedure well, ductography produces patient discomfort from cannulation of the duct and injection of contrast.

Magnetic resonance imaging

Dynamic contrast-enhanced magnetic resonance imaging (MRI) is the most sensitive imaging study for evaluating pathologic nipple discharge, and it has largely replaced ductography as an adjunct to mammography and ultrasonography. MRI’s sensitivity for detecting breast cancer ranges from 93% to 100%.⁶ In addition, MRI allows visualization of the entire breast and areas peripheral to the field of view of a standard ductogram or ultrasound scan.⁹

Clinicians commonly ask, “Why not skip the mammogram and ultrasound scan and go straight to MRI, since it is so much more sensitive?” Breast MRI has several limitations, including relatively low specificity, cost, use of intravenous contrast, and patient discomfort (that is, claustrophobia, prone positioning). MRI should be utilized for pathologic discharge only when the mammogram and/or targeted ultrasound scans are negative or equivocal.

CASE Continued: Additional imaging

A contrast-enhanced MRI of the breasts (FIGURE 4) demonstrates a large area of non-mass enhancement (red oval) in the left breast, which involves most of the upper breast extending from the nipple to the posterior breast tissue; it measures approximately 7.3 x 14 x 9.1 cm in transverse, anteroposterior, and craniocaudal dimensions, respectively. There is no evidence of left pectoralis muscle involvement. An MRI-directed second look left breast ultrasonography (FIGURE 5) is performed, revealing a small irregular mass in the left breast 1 o’clock position, 10 to 11 cm from the nipple (red arrow). This area had not been imaged in the prior ultrasound scan due to its posterior location far from the nipple. Ultrasound-guided core needle biopsy is performed; moderately differentiated invasive ductal carcinoma (IDC) with high-grade DCIS is found.

Continue to: When to refer for surgery...

When to refer for surgery

No surgical evaluation or intervention is needed for physiologic nipple discharge. As mentioned previously, reassure the patient and recommend appropriate breast cancer screening. In the setting of pathologic discharge, however, referral to a breast surgeon may be indicated after appropriate imaging workup has been done.

Since abnormal imaging almost always results in a recommendation for image-guided biopsy, typically the biopsy is performed prior to the surgical consultation. Once the pathology report from the biopsy is available, the radiologist makes a radiologic-pathologic concordance statement and recommends surgical consultation. This process allows the surgeon to have all the necessary information at the initial visit.

However, in the setting of pathologic nipple discharge with normal breast imaging, the surgeon and patient may opt for close observation or surgery for definitive diagnosis. Surgical options include single-duct excision when nipple discharge is localized to one duct or central duct excision when nipple discharge cannot be localized to one duct.

CASE Continued: Follow-up

The patient was referred to a breast surgeon. Given the extent of disease in the left breast, breast conservation was not possible. The patient underwent left breast simple mastectomy with sentinel lymph node biopsy and prophylactic right simple mastectomy. Final pathology results revealed stage IA IDC with DCIS. Sentinel lymph nodes were negative for malignancy. The patient underwent adjuvant left chest wall radiation, endocrine therapy with tamoxifen, and implant reconstruction. After 2 years of follow-up, she is disease free.

In summary

Nipple discharge can be classified as physiologic or pathologic. For pathologic discharge, a thorough physical examination should be performed with subsequent imaging evaluation. First-line tools, based on patient age, include diagnostic mammography and targeted ultrasonography. Contrast-enhanced MRI is then recommended for negative or equivocal cases. All patients with pathologic nipple discharge should be referred to a breast surgeon following appropriate imaging evaluation. ●

CASE Young woman with discharge from one nipple

A 26-year-old African American woman pre­sents with a 10-month history of left nipple discharge. The patient describes the discharge as spontaneous, colored dark brown to yellow, and occurring from a single opening in the nipple. The discharge is associated with left breast pain and fullness, without a palpable lump. The patient has no family or personal history of breast cancer.

Nipple discharge is the third most common breast-related symptom (after palpable masses and breast pain), with an estimated prevalence of 5% to 8% among premenopausal women.¹ While most causes of nipple discharge reflect benign issues, approximately 5% to 12% of breast cancers have nipple discharge as the only symptom.² Not surprisingly, nipple discharge creates anxiety for both patients and clinicians.

In this article, we—a breast imaging radiologist, gynecologist, and breast surgeon—outline key steps for evaluating and managing patients with nipple discharge.

Two types of nipple discharge

Nipple discharge can be characterized as physiologic or pathologic. The distinction is based on the patient’s history in conjunction with the clinical breast exam.

Physiologic nipple discharge often is bilateral, nonspontaneous, and white, yellow, green, or brown (TABLE).³ It often is due to nipple stimulation, and the patient can elicit discharge by manually manipulating the breast. Usually, multiple ducts are involved. Galactorrhea refers specifically to milky discharge and occurs most commonly during pregnancy or lactation.² Galactorrhea that is not associated with pregnancy or lactation often is related to elevated prolactin or thyroid-stimulating hormone levels or to medications. One study reported that no cancers were found when discharge was nonspontaneous and colored or milky.⁴

Pathologic nipple discharge is defined as a spontaneous, bloody, clear, or single-duct discharge. A palpable mass in the same breast automatically increases the suspicion of the discharge, regardless of its color or spontaneity.² The most common cause of pathologic nipple discharge is an intraductal papilloma, a benign epithelial tumor, which accounts for approximately 57% of cases.⁵

Although the risk of malignancy is low for all patients with nipple discharge, increasing age is associated with increased risk of breast cancer. One study demonstrated that among women aged 40 to 60 years presenting with nipple discharge, the prevalence of invasive cancer is 10%, and the percentage jumps to 32% among women older than 60.⁶

Breast exam. For any patient with nonlactational nipple discharge, we recommend a thorough breast examination. Deep palpation of all quadrants of the symptomatic breast, especially near the nipple areolar complex, should elicit nipple discharge without any direct squeezing of the nipple. If the patient’s history and physical exam are consistent with physiologic discharge, no further workup is needed. Reassure the patient and recommend appropriate breast cancer screening. Encourage the patient to decrease stimulation or manual manipulation of the nipples if the discharge bothers her.

Continue to: CASE Continued: Workup...

CASE Continued: Workup

On physical exam, the patient’s breasts are noted to be cup size DDD and asymmetric, with the left breast larger than the right; there is no contour deformity. There is no skin or nipple retraction, skin rash, swelling, or nipple changes bilaterally. No dominant masses are appreciated bilaterally. Manual compression elicits no nipple discharge.

Although the discharge is nonbloody, its spontaneity, unilaterality, and single-duct/orifice origin suggest a pathologic cause. The patient is referred for breast imaging.

Imaging workup for pathologic discharge

The American College of Radiology (ACR) Appropriateness Criteria is a useful tool that provides an evidence-based, easy-to-use algorithm for breast imaging in the patient with pathologic nipple discharge (FIGURE 1).⁶ The algorithm is categorized by patient age, with diagnostic mammography recommended for women aged 30 and older.⁶ Diagnostic mammography is recommended if the patient has not had a mammogram study in the last 6 months.⁶ For patients with no prior mammograms, we recommend bilateral diagnostic mammography to compare symmetry of the breasts.

Currently, no studies show that digital breast tomosynthesis (3-D mammography) has a benefit compared with standard 2-D mammography in women with pathologic nipple discharge.⁶ Given the increased sensitivity of digital breast tomosynthesis for cancer detection, however, in our practice it is standard to use tomosynthesis in the diagnostic evaluation of most patients.

Mammography

On mammography, ductal carcinoma in situ (DCIS) usually presents as calcifications. Both the morphology and distribution of calcifications are used to characterize them as suspicious or, typically, benign. DCIS usually presents as fine pleomorphic or fine linear branching calcifications in a segmental or linear distribution. In patients with pathologic nipple discharge and no other symptoms, the radiologist must closely examine the retroareolar region of the breast to assess for faint calcifications. Magnification views also can be performed to better characterize calcifications.

The sensitivity of mammography for nipple discharge varies in the literature, ranging from approximately 15% to 68%, with a specificity range of 38% to 98%.⁶ This results in a relatively low positive predictive value but a high negative predictive value of 90%.⁷ Mammographic sensitivity largely is limited by increased breast density. As more data emerge on the utility of digital breast tomosynthesis in dense breasts, mammographic sensitivity for nipple discharge will likely increase.

Ultrasonography

As an adjunct to mammography, the ACR Appropriateness Criteria recommends targeted (or “limited”) ultrasonography of the retroareolar region of the affected breast for patients aged 30 and older. Ultrasonography is useful to assess for intraductal masses and architectural distortion, and it has higher sensitivity but lower specificity than mammography. The sensitivity of ultrasonography for detecting breast cancer in patients presenting with nipple discharge is reported to be 56% to 80%.⁶ Ultrasonography can identify lesions not visible mammographically in 63% to 69% of cases.⁸ Although DCIS usually presents as calcifications, it also can present as an intraductal mass on ultrasonography.

The ACR recommends targeted ultrasonography for patients with nipple discharge and a negative mammogram, or to evaluate a suspicious mammographic abnormality such as architectural distortion, focal asymmetry, or a mass.⁶ For patient comfort, ultrasonography is the preferred modality for image-guided biopsy.

For women younger than 30 years, targeted ultrasonography is the initial imaging study of choice, according to the ACR criteria.⁶ Women younger than 30 years with pathologic nipple discharge have a very low risk of breast cancer and tend to have higher breast density, making mammography less useful. Although the radiation dose from mammography is negligible given technological improvements and dose-reduction techniques, ultrasonography remains the preferred initial imaging modality in young women, not only for nipple discharge but also for palpable lumps and focal breast pain.

Mammography is used as an adjunct to ultrasonography in women younger than 30 years when a suspicious abnormality is detected on ultrasonography, such as an intraductal mass or architectural distortion. In these cases, mammography can be used to assess for extent of disease or to visualize suspicious calcifications not well seen on ultrasonography.

For practical purposes regarding which imaging study to order for a patient, it is most efficient to order both a diagnostic mammogram (with tomosynthesis, if possible) and a targeted ultrasound scan of the affected breast. Even if both orders are not needed, having them available increases efficiency for both the radiologist and the ordering physician.

Continue to: CASE Continued: Imaging findings...

CASE Continued: Imaging findings

Given her age, the patient initially undergoes targeted ultrasonography. The grayscale image (FIGURE 2) demonstrates multiple mildly dilated ducts (white arrows) with surrounding hyperechogenicity of the fat (red arrows), indicating soft tissue edema. No intraductal mass is imaged. Given that the ultrasonography findings are not completely negative and are equivocal for malignancy, bilateral diagnostic mammography (FIGURE 3, left breast only) is performed. Standard full-field craniocaudal (FIGURE 3A) and mediolateral oblique (FIGURE 3B) mammographic views demonstrate a heterogeneously dense breast with a few calcifications in the retroareolar left breast (red ovals). No associated mass or architectural distortions are noted. The mammographic and sonographic findings do not reveal a definitive biopsy target.

Ductography

When a suspicious abnormality is visualized on either mammography or ultrasonography, the standard of care is to perform an image-guided biopsy of the abnormality. When the standard workup is negative or equivocal, the standard of care historically was to perform ductography.

Ductography is an invasive procedure that involves cannulating the suspicious duct with a small catheter and injecting radiopaque dye into the duct under mammographic guidance. While the sensitivity of ductography is higher than that of both mammography and ultrasonography, its specificity is lower than that of either modality.

Most cases of pathologic discharge are spontaneous and are not reproducible on the day of the procedure. If the procedural radiologist cannot visualize the duct that is producing the discharge, the procedure cannot be performed. Although most patients tolerate the procedure well, ductography produces patient discomfort from cannulation of the duct and injection of contrast.

Magnetic resonance imaging

Dynamic contrast-enhanced magnetic resonance imaging (MRI) is the most sensitive imaging study for evaluating pathologic nipple discharge, and it has largely replaced ductography as an adjunct to mammography and ultrasonography. MRI’s sensitivity for detecting breast cancer ranges from 93% to 100%.⁶ In addition, MRI allows visualization of the entire breast and areas peripheral to the field of view of a standard ductogram or ultrasound scan.⁹

Clinicians commonly ask, “Why not skip the mammogram and ultrasound scan and go straight to MRI, since it is so much more sensitive?” Breast MRI has several limitations, including relatively low specificity, cost, use of intravenous contrast, and patient discomfort (that is, claustrophobia, prone positioning). MRI should be utilized for pathologic discharge only when the mammogram and/or targeted ultrasound scans are negative or equivocal.

CASE Continued: Additional imaging

A contrast-enhanced MRI of the breasts (FIGURE 4) demonstrates a large area of non-mass enhancement (red oval) in the left breast, which involves most of the upper breast extending from the nipple to the posterior breast tissue; it measures approximately 7.3 x 14 x 9.1 cm in transverse, anteroposterior, and craniocaudal dimensions, respectively. There is no evidence of left pectoralis muscle involvement. An MRI-directed second look left breast ultrasonography (FIGURE 5) is performed, revealing a small irregular mass in the left breast 1 o’clock position, 10 to 11 cm from the nipple (red arrow). This area had not been imaged in the prior ultrasound scan due to its posterior location far from the nipple. Ultrasound-guided core needle biopsy is performed; moderately differentiated invasive ductal carcinoma (IDC) with high-grade DCIS is found.

Continue to: When to refer for surgery...

When to refer for surgery

No surgical evaluation or intervention is needed for physiologic nipple discharge. As mentioned previously, reassure the patient and recommend appropriate breast cancer screening. In the setting of pathologic discharge, however, referral to a breast surgeon may be indicated after appropriate imaging workup has been done.

Since abnormal imaging almost always results in a recommendation for image-guided biopsy, typically the biopsy is performed prior to the surgical consultation. Once the pathology report from the biopsy is available, the radiologist makes a radiologic-pathologic concordance statement and recommends surgical consultation. This process allows the surgeon to have all the necessary information at the initial visit.

However, in the setting of pathologic nipple discharge with normal breast imaging, the surgeon and patient may opt for close observation or surgery for definitive diagnosis. Surgical options include single-duct excision when nipple discharge is localized to one duct or central duct excision when nipple discharge cannot be localized to one duct.

CASE Continued: Follow-up

The patient was referred to a breast surgeon. Given the extent of disease in the left breast, breast conservation was not possible. The patient underwent left breast simple mastectomy with sentinel lymph node biopsy and prophylactic right simple mastectomy. Final pathology results revealed stage IA IDC with DCIS. Sentinel lymph nodes were negative for malignancy. The patient underwent adjuvant left chest wall radiation, endocrine therapy with tamoxifen, and implant reconstruction. After 2 years of follow-up, she is disease free.

In summary

Nipple discharge can be classified as physiologic or pathologic. For pathologic discharge, a thorough physical examination should be performed with subsequent imaging evaluation. First-line tools, based on patient age, include diagnostic mammography and targeted ultrasonography. Contrast-enhanced MRI is then recommended for negative or equivocal cases. All patients with pathologic nipple discharge should be referred to a breast surgeon following appropriate imaging evaluation. ●

CASE Young woman with discharge from one nipple

A 26-year-old African American woman pre­sents with a 10-month history of left nipple discharge. The patient describes the discharge as spontaneous, colored dark brown to yellow, and occurring from a single opening in the nipple. The discharge is associated with left breast pain and fullness, without a palpable lump. The patient has no family or personal history of breast cancer.

Nipple discharge is the third most common breast-related symptom (after palpable masses and breast pain), with an estimated prevalence of 5% to 8% among premenopausal women.¹ While most causes of nipple discharge reflect benign issues, approximately 5% to 12% of breast cancers have nipple discharge as the only symptom.² Not surprisingly, nipple discharge creates anxiety for both patients and clinicians.

In this article, we—a breast imaging radiologist, gynecologist, and breast surgeon—outline key steps for evaluating and managing patients with nipple discharge.

Two types of nipple discharge

Nipple discharge can be characterized as physiologic or pathologic. The distinction is based on the patient’s history in conjunction with the clinical breast exam.

Physiologic nipple discharge often is bilateral, nonspontaneous, and white, yellow, green, or brown (TABLE).³ It often is due to nipple stimulation, and the patient can elicit discharge by manually manipulating the breast. Usually, multiple ducts are involved. Galactorrhea refers specifically to milky discharge and occurs most commonly during pregnancy or lactation.² Galactorrhea that is not associated with pregnancy or lactation often is related to elevated prolactin or thyroid-stimulating hormone levels or to medications. One study reported that no cancers were found when discharge was nonspontaneous and colored or milky.⁴

Pathologic nipple discharge is defined as a spontaneous, bloody, clear, or single-duct discharge. A palpable mass in the same breast automatically increases the suspicion of the discharge, regardless of its color or spontaneity.² The most common cause of pathologic nipple discharge is an intraductal papilloma, a benign epithelial tumor, which accounts for approximately 57% of cases.⁵

Although the risk of malignancy is low for all patients with nipple discharge, increasing age is associated with increased risk of breast cancer. One study demonstrated that among women aged 40 to 60 years presenting with nipple discharge, the prevalence of invasive cancer is 10%, and the percentage jumps to 32% among women older than 60.⁶

Breast exam. For any patient with nonlactational nipple discharge, we recommend a thorough breast examination. Deep palpation of all quadrants of the symptomatic breast, especially near the nipple areolar complex, should elicit nipple discharge without any direct squeezing of the nipple. If the patient’s history and physical exam are consistent with physiologic discharge, no further workup is needed. Reassure the patient and recommend appropriate breast cancer screening. Encourage the patient to decrease stimulation or manual manipulation of the nipples if the discharge bothers her.

Continue to: CASE Continued: Workup...

CASE Continued: Workup

On physical exam, the patient’s breasts are noted to be cup size DDD and asymmetric, with the left breast larger than the right; there is no contour deformity. There is no skin or nipple retraction, skin rash, swelling, or nipple changes bilaterally. No dominant masses are appreciated bilaterally. Manual compression elicits no nipple discharge.

Although the discharge is nonbloody, its spontaneity, unilaterality, and single-duct/orifice origin suggest a pathologic cause. The patient is referred for breast imaging.

Imaging workup for pathologic discharge

The American College of Radiology (ACR) Appropriateness Criteria is a useful tool that provides an evidence-based, easy-to-use algorithm for breast imaging in the patient with pathologic nipple discharge (FIGURE 1).⁶ The algorithm is categorized by patient age, with diagnostic mammography recommended for women aged 30 and older.⁶ Diagnostic mammography is recommended if the patient has not had a mammogram study in the last 6 months.⁶ For patients with no prior mammograms, we recommend bilateral diagnostic mammography to compare symmetry of the breasts.

Currently, no studies show that digital breast tomosynthesis (3-D mammography) has a benefit compared with standard 2-D mammography in women with pathologic nipple discharge.⁶ Given the increased sensitivity of digital breast tomosynthesis for cancer detection, however, in our practice it is standard to use tomosynthesis in the diagnostic evaluation of most patients.

Mammography

On mammography, ductal carcinoma in situ (DCIS) usually presents as calcifications. Both the morphology and distribution of calcifications are used to characterize them as suspicious or, typically, benign. DCIS usually presents as fine pleomorphic or fine linear branching calcifications in a segmental or linear distribution. In patients with pathologic nipple discharge and no other symptoms, the radiologist must closely examine the retroareolar region of the breast to assess for faint calcifications. Magnification views also can be performed to better characterize calcifications.

The sensitivity of mammography for nipple discharge varies in the literature, ranging from approximately 15% to 68%, with a specificity range of 38% to 98%.⁶ This results in a relatively low positive predictive value but a high negative predictive value of 90%.⁷ Mammographic sensitivity largely is limited by increased breast density. As more data emerge on the utility of digital breast tomosynthesis in dense breasts, mammographic sensitivity for nipple discharge will likely increase.

Ultrasonography

As an adjunct to mammography, the ACR Appropriateness Criteria recommends targeted (or “limited”) ultrasonography of the retroareolar region of the affected breast for patients aged 30 and older. Ultrasonography is useful to assess for intraductal masses and architectural distortion, and it has higher sensitivity but lower specificity than mammography. The sensitivity of ultrasonography for detecting breast cancer in patients presenting with nipple discharge is reported to be 56% to 80%.⁶ Ultrasonography can identify lesions not visible mammographically in 63% to 69% of cases.⁸ Although DCIS usually presents as calcifications, it also can present as an intraductal mass on ultrasonography.

The ACR recommends targeted ultrasonography for patients with nipple discharge and a negative mammogram, or to evaluate a suspicious mammographic abnormality such as architectural distortion, focal asymmetry, or a mass.⁶ For patient comfort, ultrasonography is the preferred modality for image-guided biopsy.

For women younger than 30 years, targeted ultrasonography is the initial imaging study of choice, according to the ACR criteria.⁶ Women younger than 30 years with pathologic nipple discharge have a very low risk of breast cancer and tend to have higher breast density, making mammography less useful. Although the radiation dose from mammography is negligible given technological improvements and dose-reduction techniques, ultrasonography remains the preferred initial imaging modality in young women, not only for nipple discharge but also for palpable lumps and focal breast pain.

Mammography is used as an adjunct to ultrasonography in women younger than 30 years when a suspicious abnormality is detected on ultrasonography, such as an intraductal mass or architectural distortion. In these cases, mammography can be used to assess for extent of disease or to visualize suspicious calcifications not well seen on ultrasonography.

For practical purposes regarding which imaging study to order for a patient, it is most efficient to order both a diagnostic mammogram (with tomosynthesis, if possible) and a targeted ultrasound scan of the affected breast. Even if both orders are not needed, having them available increases efficiency for both the radiologist and the ordering physician.

Continue to: CASE Continued: Imaging findings...

CASE Continued: Imaging findings

Given her age, the patient initially undergoes targeted ultrasonography. The grayscale image (FIGURE 2) demonstrates multiple mildly dilated ducts (white arrows) with surrounding hyperechogenicity of the fat (red arrows), indicating soft tissue edema. No intraductal mass is imaged. Given that the ultrasonography findings are not completely negative and are equivocal for malignancy, bilateral diagnostic mammography (FIGURE 3, left breast only) is performed. Standard full-field craniocaudal (FIGURE 3A) and mediolateral oblique (FIGURE 3B) mammographic views demonstrate a heterogeneously dense breast with a few calcifications in the retroareolar left breast (red ovals). No associated mass or architectural distortions are noted. The mammographic and sonographic findings do not reveal a definitive biopsy target.

Ductography

When a suspicious abnormality is visualized on either mammography or ultrasonography, the standard of care is to perform an image-guided biopsy of the abnormality. When the standard workup is negative or equivocal, the standard of care historically was to perform ductography.

Ductography is an invasive procedure that involves cannulating the suspicious duct with a small catheter and injecting radiopaque dye into the duct under mammographic guidance. While the sensitivity of ductography is higher than that of both mammography and ultrasonography, its specificity is lower than that of either modality.

Most cases of pathologic discharge are spontaneous and are not reproducible on the day of the procedure. If the procedural radiologist cannot visualize the duct that is producing the discharge, the procedure cannot be performed. Although most patients tolerate the procedure well, ductography produces patient discomfort from cannulation of the duct and injection of contrast.

Magnetic resonance imaging

Dynamic contrast-enhanced magnetic resonance imaging (MRI) is the most sensitive imaging study for evaluating pathologic nipple discharge, and it has largely replaced ductography as an adjunct to mammography and ultrasonography. MRI’s sensitivity for detecting breast cancer ranges from 93% to 100%.⁶ In addition, MRI allows visualization of the entire breast and areas peripheral to the field of view of a standard ductogram or ultrasound scan.⁹

Clinicians commonly ask, “Why not skip the mammogram and ultrasound scan and go straight to MRI, since it is so much more sensitive?” Breast MRI has several limitations, including relatively low specificity, cost, use of intravenous contrast, and patient discomfort (that is, claustrophobia, prone positioning). MRI should be utilized for pathologic discharge only when the mammogram and/or targeted ultrasound scans are negative or equivocal.

CASE Continued: Additional imaging

A contrast-enhanced MRI of the breasts (FIGURE 4) demonstrates a large area of non-mass enhancement (red oval) in the left breast, which involves most of the upper breast extending from the nipple to the posterior breast tissue; it measures approximately 7.3 x 14 x 9.1 cm in transverse, anteroposterior, and craniocaudal dimensions, respectively. There is no evidence of left pectoralis muscle involvement. An MRI-directed second look left breast ultrasonography (FIGURE 5) is performed, revealing a small irregular mass in the left breast 1 o’clock position, 10 to 11 cm from the nipple (red arrow). This area had not been imaged in the prior ultrasound scan due to its posterior location far from the nipple. Ultrasound-guided core needle biopsy is performed; moderately differentiated invasive ductal carcinoma (IDC) with high-grade DCIS is found.

Continue to: When to refer for surgery...

When to refer for surgery

No surgical evaluation or intervention is needed for physiologic nipple discharge. As mentioned previously, reassure the patient and recommend appropriate breast cancer screening. In the setting of pathologic discharge, however, referral to a breast surgeon may be indicated after appropriate imaging workup has been done.

Since abnormal imaging almost always results in a recommendation for image-guided biopsy, typically the biopsy is performed prior to the surgical consultation. Once the pathology report from the biopsy is available, the radiologist makes a radiologic-pathologic concordance statement and recommends surgical consultation. This process allows the surgeon to have all the necessary information at the initial visit.

However, in the setting of pathologic nipple discharge with normal breast imaging, the surgeon and patient may opt for close observation or surgery for definitive diagnosis. Surgical options include single-duct excision when nipple discharge is localized to one duct or central duct excision when nipple discharge cannot be localized to one duct.

CASE Continued: Follow-up

The patient was referred to a breast surgeon. Given the extent of disease in the left breast, breast conservation was not possible. The patient underwent left breast simple mastectomy with sentinel lymph node biopsy and prophylactic right simple mastectomy. Final pathology results revealed stage IA IDC with DCIS. Sentinel lymph nodes were negative for malignancy. The patient underwent adjuvant left chest wall radiation, endocrine therapy with tamoxifen, and implant reconstruction. After 2 years of follow-up, she is disease free.

In summary

Nipple discharge can be classified as physiologic or pathologic. For pathologic discharge, a thorough physical examination should be performed with subsequent imaging evaluation. First-line tools, based on patient age, include diagnostic mammography and targeted ultrasonography. Contrast-enhanced MRI is then recommended for negative or equivocal cases. All patients with pathologic nipple discharge should be referred to a breast surgeon following appropriate imaging evaluation. ●