Women’s health updates beyond the pandemic

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 Contemporary OB/GYN®. 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 here 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).¹ 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 this article. 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.² 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 New England Journal of Medicine published “Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception.”³ 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 Obstetrics & Gynecology last October.⁴ 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.

References

1. 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. JAMA. 2019;322(19):1877–1886. doi:10.1001/jama.2019.16004
2. 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.
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. N Engl J Med. 2021 Jan 28;384(4):335-344. doi:10.1056/NEJMoa2022141.
4. Berkley HH, Greene HL, Wittenberger MD. Mifepristone combination therapy compared with Misoprostol monotherapy for the management of miscarriage: A cost-effectiveness analysis. Obstet Gynecol. 2020 Oct;136(4):774-781. doi:10.1097/AOG.0000000000004063.