Q3 Recap: What's new in obstetrics and gynecology?

Q3 Recap: What's new in obstetrics and gynecology? | Image Credit: © oatawa - stock.adobe.com.

As we near the finish of 2025, the third quarter has delivered major advancements across cervical cancer screening, infectious disease management, and preventive women’s health.

From FDA approvals and clinical trial breakthroughs to evolving screening technologies and expert insights on disparities and lifestyle interventions, these developments reflect the ongoing innovation in gynecologic care.

In this Q3 recap, Contemporary OB/GYN highlights the most impactful regulatory decisions, research findings, and expert commentary shaping women’s health in 2025 and beyond.

Click on each title below for full coverage and clinical insights.

Q3 2025 regulatory updates in ob-gyn

FDA pushes label change for acetaminophen in pregnancy, approves leucovorin calcium for CFD

Prenatal acetaminophen exposure may be associated with increased risk of neurodevelopmental disorders, according to evidence prompting the FDA to initiate a label change for Tylenol and related products. Large cohort studies, including the Nurses’ Health Study II and Boston Birth Cohort, have linked chronic maternal use during pregnancy to a 20% to 30% increased risk of autism spectrum disorder and ADHD in offspring, though causality remains unproven. In parallel, the FDA approved leucovorin calcium (Wellcovorin) for cerebral folate deficiency, a rare neurologic disorder presenting with developmental delay, seizures, and autistic features. The approval was supported by mechanistic studies and case reports published between 2009 and 2024.

FDA extends review period for Bayer's elinzanetant for vasomotor symptoms

On July 25, 2025, Bayer announced that the FDA extended its review of elinzanetant, a first-in-class dual neurokinin 1 and 3 receptor antagonist for vasomotor symptoms in menopause, by up to 90 days.

The delay allows time to evaluate the full NDA, supported by 3 phase 3 trials (OASIS 1, 2, and 3). No safety or efficacy concerns were raised. Already approved in the UK and Canada as Lynkuet, elinzanetant may offer a novel nonhormonal treatment option for moderate to severe menopause-related vasomotor symptoms.

FDA grants Priority Review to flibanserin for treating postmenopausal HSDD

On July 24, 2025, the FDA granted Priority Review to Sprout Pharmaceuticals’ application to expand flibanserin (Addyi) use to postmenopausal women with hypoactive sexual desire disorder (HSDD).

Flibanserin is currently the only FDA-approved oral treatment for low sexual desire in women. If approved for postmenopausal use, it would extend access to a broader population. The nonhormonal therapy influences key neurotransmitters related to sexual response. Already approved in Canada for menopausal women, flibanserin’s expanded indication would address a significant unmet need in women’s sexual health.

Q3 2025 top headlines in ob-gyn

Study finds weight loss before IVF may boost pregnancy rates

Weight loss prior to in vitro fertilization (IVF) may increase pregnancy rates, according to a meta-analysis published in the Annals of Internal Medicine. Across 12 randomized controlled trials including 1921 women with obesity, pre-IVF weight loss was linked to higher overall pregnancy rates (RR, 1.21) and greater odds of unassisted conception (RR, 1.47). However, evidence for improved live birth outcomes was uncertain due to small study sizes and high risk of bias. Investigators noted that further large, high-quality trials are needed to clarify effects on live births.

OASIS-3 highlights safety and efficacy of elinzanetant against VMS

Elinzanetant significantly reduced vasomotor symptoms (VMS) in postmenopausal women, according to results of the phase 3 OASIS-3 trial published in JAMA Internal Medicine. Among 628 participants randomized to elinzanetant 120 mg or placebo for 52 weeks, elinzanetant achieved a 73.8% reduction in moderate to severe hot flashes and night sweats by week 12 compared with 47% in the placebo group. Benefits included improved sleep and menopause-specific quality-of-life scores, with effects sustained through 50 weeks. Adverse events occurred in 70% of patients receiving elinzanetant and 61% on placebo, but were mostly mild or moderate, with no treatment-related serious events reported. Investigators concluded elinzanetant offers a safe and effective non-hormonal option for VMS management.

ACOG updates clinical guidance on delayed umbilical cord clamping in preterm neonates

In July 2025, ACOG issued updated clinical guidance recommending delayed umbilical cord clamping for at least 60 seconds in preterm neonates born before 37 weeks, based on recent meta-analyses.

The new guidance, which revises 2020 recommendations, is supported by data showing a significant reduction in neonatal mortality with deferred clamping versus immediate clamping. While cord milking may be used when deferral is not possible, especially between 28 and 36 weeks, ACOG emphasized individualized care and called for more evidence before routinely adopting clamping delays of 120 seconds or longer.

Q3 2025 expert perspectives in ob-gyn

In this section, click the "play" button on each video interview to watch.

JoAnn Pinkerton, MD, highlights long-term safety and efficacy of elinzanetant

The recently published 52-week OASIS-3 trial evaluated the safety and efficacy of elinzanetant, a non-hormonal treatment for vasomotor symptoms (VMS) such as hot flashes and night sweats. In this video interview, JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia, explained that participants taking elinzanetant experienced more than a 73% reduction in the frequency and severity of symptoms by week 12. Specifically, the mean number of vasomotor episodes dropped from 6.7 per day in the elinzanetant group to 1.6, compared with a decline from 6.8 to 3.4 in the placebo group. In addition to reducing VMS, patients reported improvements in sleep quality and menopause-related quality of life, though these secondary outcomes require further evaluation to fully understand their scope.

Special Report: Advances in STI screening and treatments

To mark Sexual Health Awareness Month, Contemporary Pediatrics partnered with Contemporary OB/GYN for a cross-specialty discussion on advances in sexually transmitted infection (STI) screening and management. The session, moderated by Kylee Johnson, MS, APRN, focused on how updated diagnostic tools and regulatory changes affect both maternal and pediatric care.

Neonatal specialist Brooke Redmond, MD, highlighted the pediatric implications of untreated maternal infections, including congenital syphilis, HIV, and neonatal herpes. She noted that pediatricians play a critical role in early detection, follow-up testing, and multidisciplinary collaboration to safeguard infant outcomes.

Diagnostic scientist Denise Haney, PhD, of Roche Diagnostics, outlined how molecular testing platforms are reshaping STI detection, offering higher sensitivity and expanding into at-home collection kits. For pediatric providers, understanding these diagnostic shifts is vital—both for counseling parents and for coordinating care with obstetric colleagues.