Angie DeRosa

® Senior Editor Angie DeRosa compiled the following report based on a presentation at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting (ACSM) by Editorial Board member Christine R. Isaacs, MD; and William M. Leininger, MD. 

Isaacs and Leininger presented the Kathryn M. and Thomas F. Purdon, MD, Generalists Session “While You Were Slee(PPE)ing: Women’s Health Updates Beyond the Pandemic’s Priorities” on May 2, the final day of the conference. It was a joint session of ACOG and the Society of Academic Specialists in General Obstetrics and Gynecology (SASGOG).

Isaacs and Leininger provided ACOG ACSM attendees with a high-level overview on clinically valuable updates that may have been pushed to the back burner as COVID-19–related medical care dominated 2020.

Isaacs is an ob/gyn, a professor, academic specialist division chief, and medical director of midwifery services at the Virginia Commonwealth University School of Medicine in Richmond. Leininger is an ob/gyn at Naval Medical Center San Diego in California. He is an assistant professor of ob/gyn at the Uniformed Services University of Health Sciences in Bethesda, Maryland.

The actionable, direct patient care updates discussed by Isaacs and Leininger were published from late 2019 through 2020. However, during that time frame, many practice-based learning activities understandably focused on pandemic changes, and clinical practice was overwhelmed with pandemic adaptation and response activities. 

Their presentation identified high-value actionable updates for the generalist ob/gyn based on importance to one’s general clinical practice. Out of respect for content covered in other venues, they purposely chose focuses 

related to COVID-19; diversity, equity, and inclusion; policy; and content identified in ACOG Practice Bulletins, Committee Opinions, Choose Wisely, or in the Consult Series from the Society for Maternal-Fetal Medicine (SMFM) all of which can be easily accessed by ACOG members. Isaacs and Leininger selected 30 articles of high value and interest that were screened based on title and abstract from multiple journals and health care organizations. 

The SASGOG board of directors reviewed and reprioritized the list to cover high volume and high consequence conditions. Isaacs and Leininger then selected the top 14 and summarized each. “The SASGOG Board of Directors ultimately selected these articles to cover both high volume and high consequence conditions,” Leininger said.

Gonococcal Infection Treatment Guidelines

The first topic involved updated guidelines from the Centers for Disease Control and Prevention (CDC) for uncomplicated cases of gonococcal infection.

 The guidelines recommend single-agent treatment with ceftriaxone based on a person’s weight (500 mg intramuscular (IM) as a single dose for patients weighing 150 kg/~300 lb or less and 1 g intramuscularly for persons weighing 150kg/~300 lb or more. These changes reflect the low incidence of ceftriaxone resistance and continued efforts at antimicrobial stewardship. The updated guidelines state that if chlamydia infection has not been excluded, providers should treat for such with doxycycline 100 mg orally twice per day for 7 days in a nonpregnant state or with azithromycin 1 g as a single dose during pregnancy.

The CDC has an app, STD Treatment (Tx) Guide, that can be downloaded from Apple’s App store or Google Play with the current updated guidelines.

For hepatitis C virus infection in adolescents and adults, the US Preventive Services Task Force now recommends screening for all including pregnant and nonpregnant individuals.

There is no vaccine, nor is pre- or postexposure prophylaxis available. The virus spreads primarily through parenteral exposure, blood, body fluids with blood, and injection drug use. The suggested practice change is to include hepatitis C antibody screening in new obstetric lab panels as this is often the first opportunity for patients to initiate health care and screening.

Treating Couples with Unexplained Infertility

In February 2020, the American Society for Reproductive Medicine published new practice guidelines for couples with unexplained infertility.

 These recommendations detail the evidence for various regimens using oral ovulation inducing medicines, gonadotropins, and intrauterine insemination (IUI) that have demonstrated little benefit for improving pregnancy rates or have a higher incidence of multiple gestations. Couples should start with 3 or 4 cycles of ovarian stimulation with oral agents and IUI. If that strategy is unsuccessful, then proceed to in vitro fertilization.

Umbilical Cord Milking vs DelayedUmbilical Cord Clamping

Isaacs and Leininger then moved on to an article that compared the risk of umbilical cord milking vs delayed umbilical cord clamping causing death or severe intraventricular hemorrhage (IVH) among preterm infants. The study was published in November 2019 in the 

Journal of the American Medical Association

 It included 474 preterm infants (23+0 to 31+6 weeks gestational age [wGA]). An increased risk for severe IVH was found with umbilical cord milking, especially in 23+0 to 27+6 wGA (

002), they said. The practice implication is to prioritize delayed cord clamping over umbilical cord milking for placental transfusion at delivery of 23+0 to 27+6 wGA.

A major paradigm shift occurred following the American Society for Colposcopy and Cervical Pathology (ASCCP) updated guidelines for cervical cancer screening, Isaacs said. They moved it from relying on test results for algorithms to making it risk-based, she added.

“The algorithms take into effect patients’ screening history,” Isaacs said. “Newer HPV infections are not as concerning as those that have existed and persisted.”

In addition, the American Cancer Society released recommendations in 2020 that endorsed and preferred primary HPV testing beginning at age 25. Then, in April 2021, ACOG released its practice advisory stating that screening should begin at age 21.

“We do not want to delay screening efforts,” Isaacs said. She added that for women of average risk, primary HPV screening is an option but not the only screening option. An updated app from ASCCP offers a tool for practicing ob/gyns to guide decision-making.

In October 2020, the Food and Drug Administration shared a summary of their deliberations to propose withdrawing approval of Makena, a drug that was approved for the prevention of recurrent preterm birth.

 Initial approval was accelerated because of the reduction in recurrent preterm birth. However, there was insufficient evidence at that time to evaluate newborn benefit. 

A subsequent study failed to find either newborn benefit or prolongation of pregnancy. Although a final decision on the proposal was still pending as of May 2, the date of Isaacs’ and Leininger’s presentation, clinicians will need to individualize complex issues for patients who are at risk of recurrent preterm delivery based on logistics, cost, utility, and expectation management. The experts recommended seeing recent releases from ACOG and SMFM on the meta-analysis from Evaluating Progestogens for Preventing Preterm Birth International Collaborative.

Levonorgestrel vs Copper IUD for Emergency Contraception

Next, Isaacs and Leininger covered a study that compared the use of levonorgestrel vs copper intrauterine devices (IUD) for emergency contraception. In January 2021, the 

 published “Levonorgestrel vs Copper Intrauterine Devices for Emergency Contraception,”

 which involved 711 participants who were randomly assigned in a 1:1 ratio to receive a levonorgestrel 52-mg IUD or a copper T380A IUD for emergency contraception, with a 1-month follow up to assess for pregnancy. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% CI, 0.01-1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0-1.1) in the copper IUD group, indicating that the levonorgestrel IUD was noninferior to the copper IUD for emergency contraception. 

The study holds promise for future emergency contraception options and shared decision-making for patients.

Mifepristone Combination Therapy Compared with Misoprostol Monotherapy

Another important finding covered by Isaacs and Leininger involved a cost-benefit analysis of mifepristone plus misoprostol compared with misoprostol alone for the treatment of miscarriage. For their study published in 

 investigators used decision tree analyses and Monte Carlo simulations covering variables such as medication costs, treatment success rates, need for surgery, and patient time away from work. Based on the parameters used, the analysis results showed that combination therapy was consistently more cost-effective than monotherapy.

Axillary Adenopathy in Patients with Recent COVID-19 Vaccination

Recommendations also now exist for the management of axillary adenopathy in patients with recent COVID-19 vaccination from the Society for Breast Imaging.

 In normal screening mammograms, axillary adenopathy reports are 0.2% to 0.4%, which is rare, Isaacs and Leininger said. Lymphadenopathy as an unsolicited adverse event in vaccine trials was 1.1% based on clinical assessment. The true incidence is likely higher, they explained. The related practice change is the recommendation that breast screening imaging be performed prior to vaccination when possible. If mammographic screening is required after vaccination, consider postponing screening for at least 4 to 6 weeks after the final vaccination dose to avoid false-positive results. If a clinical breast concern exists, imaging should ensue without delay.

The presenters then addressed early-onset breast cancer—cases diagnosed in patients between ages 18 and 45 years—detection by discussing the CDC’s Bring Your Brave campaign, which shares patient stories and provides information for women affected by the disease, such as gaps and disparities in cancer diagnosis, treatment, and outcomes.

Providers can take an evidence-based continuing medical education (CME)–accredited online course that reviews key concepts for early-onset breast cancer detection and/or reference “Executive Summary of the Early-Onset Breast Cancer Evidence Review Conference,” published in 

 in June 2020.11 The series will continue with future topics (uterine, ovarian, vaginal, vulvar, and anal cancers), Isaacs explained, and she encouraged attendees to take the free CME course, offered through ACOG at acog.org.

Intrapartum Oxygen Supplementation Effects on Category II Fetal Monitoring

In a randomized controlled trial, published in the June 2020 issue of the 

American Journal of Obstetrics and Gynecology

, investigators studied 114 term laboring patients randomized to room air versus 10L of oxygen per minute by face mask for Category II tracing.

 After 60 minutes, fetal heart tones were evaluated for recurrent/late variable decelerations, prolonged decelerations, tachycardia, and minimal variability, the presenters said. Investigators found that hyperoxia treatment does not appear to improve a Category II tracing. Therefore, based on this study and similar ones, clinicians should not delay other interventions while using oxygen supplementation for fetal in utero resuscitation, Leininger said.

Indicators of Early Menopause Following Opportunistic Salpingectomy

A cohort study from British Columbia, Canada, examined indicators of early menopause following opportunistic salpingectomy (OS).

 Investigators identified all women (41,413) who were 50 years or younger at the time of surgery who underwent OS from 2008 to 2014. For this cohort, they defined menopause onset as the age at the first visit for menopause symptoms or the first prescription for hormone therapy. They then allocated the patients by the following surgery types: hysterectomy alone, hysterectomy with OS, hysterectomy with bilateral salpingo-oophorectomy (BSO), tubal ligation, and OS for sterilization. Based on the study’s definition of menopause onset, only the women who underwent hysterectomy with BSO had an earlier age of onset of menopause compared with the other groups. These findings should help surgeons counsel patients about OS as a treatment option, according to Isaacs and Leininger.

Vaginal Prep with Antiseptic Solution Before Cesarean for Preventing Postoperative Infections

Isaacs and Leininger reviewed the Cochrane Library publication, which examined if vaginal preparations with antiseptic solutions done before cesarean delivery were effective in preventing postoperative infections such as endometritis and wound complications.

 The 21 trials that included 7038 women across 10 countries, Isaacs said. The antiseptics used were iodine-based or chlorhexidine solutions, as compared with saline or no vaginal cleansing. The results showed that use of vaginal antiseptic solutions probably did reduce the number of postoperative endometritis infections, wound infections, and fevers. The speakers concluded that this practice is a simple yet important intervention can have great benefit when incorporated into surgical checklists.

The Joint Commission released updated maternity care standards for hypertension and hemorrhage effective January 1, 2021.

 It expands requirements for patient assessments, unit protocols and processes for patient management, equipment and supply access, recurring education and simulation drills, case reviews, and patient education. Based on discussions with other organizations and personal experience, the presenters said obstetric practices will need to pursue sustained, iterative, multidisciplinary effort over several months to fulfill these requirements. 

The views expressed by William Leininger, MD, are his own and do not reflect the official policy or position of the Department of the Navy, Department of Defense, nor the US government.

Isaacs C and Leininger WM. The Kathryn M. and Thomas F. Purdon, MD, Generalists Session: While you were Slee(PPE)ing: women’s wealth updates beyond the pandemic’s priorities. Presented at: Virtual Meeting of the American College of Obstetricians and Gynecologists 2021 Annual Clinical and Scientific Meeting; May 2, 2021. 

acog.org/education-and-events/meetings/acog-annual-clinical-and-scientific-meeting

St Cyr S, Barbee L, Workowski KA, et al. Update to CDC’s treatment guidelines for gonococcal infection, 2020. 

 2020;69(50):1911-1916. doi:10.15585/mmwr.mm6950a6

Owens DK, Davidson KW et al; US Preventive Services Task Force. Screening for Hepatitis C virus infection in adolescents and adults:

US Preventive Services Task Force recommendation statement.

2020;323(10):970-975. doi:10.1001/jama.2020.1123

Practice Committee of the American Society for Reproductive Medicine. Evidence-based treatments for couples with unexplained infertility: a guideline.

. 2020;113(2):305-322. doi:10.1016/j.fertnstert.2019.10.014

Katheria A, Reister F, Essers J, et al. Association of umbilical cord milking vs delayed umbilical cord clamping with death or severe intraventricular hemorrhage among preterm infants. 

 2019;322(19):1877-1886. doi:10.1001/jama.2019.16004

Chang CY, Nguyen CP, Wesley B, Guo J, Johnson LL, Joffe HV. Withdrawing approval of Makena — a proposal from the FDA Center for Drug Evaluation and Research. 

. 2020;383(24):e131. doi:10.1056/NEJMp2031055

Turok DK, Gero A, Simmons RG, et al. Levonorgestrel vs. copper intrauterine devices for emergency contraception. 

. 2021;384(4):335-344. doi:10.1056/NEJMoa2022141

Berkley HH, Greene HL, Wittenberger MD. Mifepristone combination therapy compared with Misoprostol monotherapy for the management of miscarriage: a cost-effectiveness analysis. 

. 2020;136(4):774-781. doi:10.1097/AOG.0000000000004063

SBI recommendations for the management of axillary adenopathy in patients with recent COVID-19 vaccination. Society of Breast Imaging. March 9, 2021. Accessed May 11, 2021. 

sbi-online.org/Portals/0/Position%20Statements/2021/SBI-recommendations-for-managing-axillary-adenopathy-post-COVID-vaccination.pdf

Bring Your Brave Campaign. Centers for Disease Control and Prevention. Accessed May 11, 2021. 

cdc.gov/cancer/breast/young_women/bringyourbrave/about.htm

Chelmow D, Pearlman MD, Young A, et al. Executive summary of the early-onset breast cancer evidence review conference. 

 2020;135(6):1457-1478. doi:10.1097/AOG.0000000000003889

Raghuraman N, López JD, Carter EB, et al. The effect of intrapartum oxygen supplementation on category II fetal monitoring. 

. 2020; 223(6):905.e1-905.e7. doi:10.1016/j.ajog.2020.06.037

Hanley GE, Kwon JS, McAlpine JN, Huntsman DG, Finlayson SJ, Miller D. Examining indicators of early menopause following opportunistic salpingectomy: a cohort study from British Columbia, Canada. 

 2020;223(2):221.e1-221.e11. doi: 10.1016/j.ajog.2020.02.005

Haas DM, Morgan S, Contreras K, Enders S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. 

. 2018;(7):CD007892. doi:10.1002/14651858.CD007892.pub6

Updated Maternity Care Standards re: HTN and HemorrhageTJC – R3 Report: Requirement, Rationale, Reference; August 19, 2019. Accessed May 11, 2021. 

https://www.jointcommission.org/standards/r3-report/r3-report-issue-24-pc-standards-for-maternal-safety/

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Join Senior Editor Angie DeRosa as Sarah J. Kilpatrick, MD, PhD; and Christian M. Pettker, MD debate noun use. 

Board Members Debate Noun Use: Pregnant Woman or Pregnant Person? 

Senior editor Angie DeRosa interviewed Sateria Venable, Founder & CEO of the Fibroid Foundation, and Ayman Al-Hendy, MD, a professor of ob/gyn at the University of Chicago Medical Center, about patient-physician collaboration when it comes to addressing uterine fibroids. 

Addressing Uterine Fibroids with Patient-Physician Collaboration

This article includes information presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting (ACSM), held from April 30 to May 2.

Christine Isaacs, MD, and William M. Leininger, MD, presented the Kathryn M. and Thomas F. Purdon, MD, Generalists Session: While you were Slee(PPE)ing: Women’s Health Updates Beyond the Pandemic’s Priorities, on May 2, the final day of ACOG’s annual conference. It was a joint session of ACOG and the Society of Academic Specialists in General Obstetrics and Gynecology (SASGOG).

Isaacs is an ob/gyn, professor, academic specialist division chief, and medical director of midwifery services at the Virginia Commonwealth University School of Medicine in Richmond, Va. She also is a board member of 

Leininger is an ob/gyn at Naval Medical Center San Diego. He is an assistant professor of ob/gyn at the Uniformed Services University of Health Sciences in Bethesda, Md.

They provided attendees with actionable, direct patient care topics since the period from late 2019 through 2020 was so demanding due to the pandemic, economic, and political concerns. Practice-based learning activities focused on pandemic changes, and clinical practice was burdened with pandemic adaptation and response activities, they said. Their method was to identify high-value updates for the generalist ob/gyn based upon importance to clinical practice; actionable findings; clinical focus not related to COVID-19; diversity, equity, and inclusion; policy, etc.; not identified in ACOG Practice Bulletins or Committee Opinions; not identified at the Choose Wisely site or in Consult Series from the Society for Maternal-Fetal Medicine (SMFM). They screened selected articles based upon title and abstract from multiple journals and websites. Isaacs and Leininger selected 30 articles of high value and interest. The SASCGOG board of directors reviewed and reprioritized the list. Isaacs and Leininger then selected the top 14 and summarized each.

Topics included updates to the Centers for Disease Control and Prevention’s (CDC) treatment guidelines for gonococcal infection (see link 

 to the CDC’s Morbidity and Mortality Weekly Report of Dec. 18, 2020, with that update). This pertains to uncomplicated cases. The guidelines recommend ceftriaxone 500 mg intramuscular as a single dose for patients weighing less than 150 kg or 300 lbs. For patients weighing more than or equal to that, the recommendation is for ceftriaxone 1 g intramuscular. They said that if chlamydia infection is not excluded, providers should treat for it with doxycycline 100 mg orally twice per day for 7 days. If it is during pregnancy, the recommendation is treatment with azithromycin 1 g in a single dose.

The CDC has an app, STI Treatment (Tx) Guide, that can be downloaded from the iTunes App store or GooglePlay.

For Hepatitis C virus infection in adolescents and adults, the recommendation now is for screening for all including pregnant and non-pregnant individuals, they said. There is no vaccine nor is there pre- or postexposure prophylaxis available. The virus is spread primarily through parenteral exposure; blood; body fluids with blood; and injection drug use. The related practice changes is to include Hepatitis C antibody screening in your new obstetric lab panel.

There are new practice guidelines for couples with unexplained infertility. Intrauterine insemination (IUI) in unstimulated cycles is no better than treatment, they said. Clomiphene citrate or letrozole with timed cycle is no better than no treatment. There is insufficient evidence to recommend gonadotropins with timed intercourse. Gonadotropins with IUI is either no better than oral meds or high multiple rates. Clomiphene citrate or letrozole with IUI is better than natural cycle IUI or no treatment, they said. The resulting practice implication is that couples should start with 3-4 cycles of ovarian stimulation with oral agents and IUI. If that is unsuccessful, then proceed to in-vitro fertilization, they said.

The next guideline covered was the association of umbilical cord milking versus delayed umbilical cord clamping with death or severe intraventricular hemorrhage (IVH) among preterm infants. This study was published in November 2019 by the Journal of the American Medical Association (JAMA).

 It included 474 preterm infants (23+0 – 31+6 weeks gestational age (WGA). There was an increased risk for severe IVH found, especially in 23+0-27+6 WGA (p=.002), they said. The practice implication is to prioritize delayed cord clamping over umbilical cord milking for placental transfusion at delivery of 23+0-27+6 WGA.

The other significant guideline change is the ASCCP guidelines for cervical cancer screenings, Isaacs said. Those are covered in 

. The updated guidelines “switched our paradigm,” she said, moving from relying on test results for algorithms to making it risk-based.

“The algorithms take into effect patient’s screening history,” she said. “Newer HPV infections are not as concerning as those that have existed and persisted.”

When it comes to screening, the American Cancer Society (ACS) put out its recommendations in 2020 that endorsed and preferred primary HPV testing beginning at age 25. ACOG released its practice advisory in April 2021 that screening should being at age 21.

“We do not want to delay screening efforts,” Isaacs said. She added that for average risk women primary HPV screening is an option but is not the only screening option. There is an updated app from ASCCP as a tool for practicing ob/gyns.

In October, the US Food and Drug Administration proposed withdrawing approval of Makena, the drug that had been approved for the prevention of recurrent preterm birth.

 Initial approval was accelerated because of the reduction in recurrent preterm birth, Isaacs and Leininger said. There was insufficient evidence at that time of newborn benefit. A subsequent study failed to find newborn benefit or prolongation of pregnancy, they said. The implications for practice are that there are complex issues with shared-decision making for patients who are at risk for recurrent preterm delivery, based on logistics, cost, utility, and expectations management. The experts recommended seeing recent releases from ACOG and SMFM on the meta-analysis from Evaluating Progestogens for Preventing Preterm Birth International Collaborative (EPPIC).

The next update covered by Isaacs and Leininger was based upon the use of levonorgestrel versus copper intrauterine devices for emergency contraception. In January, the 

 published “Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception.”

 In the randomized noninferiority trial, 711 participants were randomly assigned in a 1:1 ratio to receive a levonorgestrel 52 mg IUD or a copper T380A IUD. Participants had a 1-month follow up. According to the study, among the 355 participants randomly assigned to receive levonorgestrel IUDs and 356 assigned to receive copper IUDs, 317 and 321, respectively, received the interventions and provided 1-month outcome data. Of these, 290 in the levonorgestrel group and 300 in the copper IUD group had a 1-month urine pregnancy test. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% confidence interval [CI], 0.01 to 1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0 to 1.1) in the copper IUD group.

The other major recommendations covered by Isaacs and Leininger were Mifepristone combination therapy compared with Misoprostol monotherapy for the prevention of miscarriage. A cost-effective analysis was published in 

 Decision tree analyses and Monte Carlo simulations found that combination therapy was consistently more cost effective, they said.

There also now are recommendations for the management of axillary adenopathy in patients with recent COVID-19 vaccination from the Society for Breast Imaging. In normal screening mammograms, axillary adenopathy reports are 0.2-0.4%, which is rare, they said. Lymphadenopathy as an unsolicited adverse event in vaccine trials was 1.1% based on clinical assessment. The true incidence is likely higher, they said. The related practice change is that imaging should be performed prior to vaccination when possible.

 2019;322(19):1877–1886. doi:10.1001/jama.2019.16004

Chang CY, Nguyen CP, Wesley B, Guo J, Johnson LL, Joffe HV. Withdrawing approval of Makena - A proposal from the FDA Center for Drug Evaluation and Research. N Engl J Med. 2020 Dec 10;383(24):e131. doi:10.1056/NEJMp2031055. Epub 2020 Nov 3.

Turok DK, Gero A, Simmons RG, Kaiser JE, Stoddard GJ, Sexsmith CD, Gawron LM, Sanders JN. Levonorgestrel vs. copper intrauterine devices for emergency contraception. 

. 2021 Jan 28;384(4):335-344. doi:10.1056/NEJMoa2022141.

Berkley HH, Greene HL, Wittenberger MD. Mifepristone combination therapy compared with Misoprostol monotherapy for the management of miscarriage: A cost-effectiveness analysis. 

. 2020 Oct;136(4):774-781. doi:10.1097/AOG.0000000000004063.

Two leading experts provided ACOG ACSM attendees with a high-level overview on clinically valuable updates that may have been pushed to the backburner as COVID-19-related medical care dominated 2020.

Angie DeRosa

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Women’s health updates beyond the pandemic