Q1 Recap: What's new in obstetrics and gynecology?

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As we enter the second quarter of 2025, Q1 brought key regulatory updates and clinical trial findings that impact the care of women across all stages of life.

In the ever-evolving field of obstetrics and gynecology, significant advancements have emerged in areas such as maternal-fetal medicine, reproductive endocrinology, gynecologic oncology, and more. From newly FDA-approved therapies to promising clinical trial data, these developments are shaping the future of patient care.

In this Q1 recap, Contemporary OB/GYN highlights the most relevant FDA approvals, clinical research insights, and expert perspectives from the first quarter of 2025.

Click on each title below for in-depth coverage of these key updates.

Q1 2025 regulatory updates in ob-gyn

FDA approves gepotidacin for uncomplicated UTI treatment

The FDA approved gepotidacin (Blujepa; GSK) for the treatment of uncomplicated urinary tract infections (uUTIs) in female patients aged 12 years and older on March 25, 2025, marking the first oral antibiotic in a new class in over 20 years. Clinical trials demonstrated its superiority over nitrofurantoin, with higher therapeutic success rates and a lower potential for resistance development.

The drug exhibited a favorable safety profile, with gastrointestinal adverse events being the most commonly reported side effects. Given the increasing prevalence of antibiotic-resistant uUTIs, gepotidacin represents a valuable new option for patients in need of effective treatment.

FDA approves Visby’s test for at-home STI identification

The FDA granted marketing authorization for the Visby Medical Women’s Sexual Health Test on March 28, 2025, making it the first at-home, prescription-free test for chlamydia, gonorrhea, and trichomoniasis. Designed for symptomatic and asymptomatic female patients, the test delivers results within approximately 30 minutes through the Visby Medical App.

Clinical evaluations demonstrated high accuracy rates, with sensitivity and specificity exceeding 97% for all 3 infections. While the FDA emphasized the importance of follow-up care, this approval marks a significant advancement in sexual health diagnostics by improving accessibility and reducing barriers to timely testing.

FDA clears Sonio Suspect AI for fetal anomaly detection

The FDA cleared the Sonio Suspect AI model for detecting fetal anomalies on February 24, 2025, offering a 22-point improvement in reader performance and enhancing early and accurate diagnoses. The technology integrates real-time AI quality control with anomaly detection, addressing gaps in prenatal ultrasound screenings, where up to 51% of anomalies go undetected.

Clinical studies demonstrated its efficacy across diverse patient demographics and clinician backgrounds, with the model significantly improving detection rates of brain and heart structures. By enabling earlier identification of congenital malformations, Sonio Suspect supports timely interventions, ultimately improving maternal and fetal health outcomes.

Q1 2025 trial announcements in ob-gyn

Revi System demonstrates positive two-year results for treating urgency urinary incontinence

The OASIS study, published on February 7, 2025, confirms the long-term efficacy and safety of BlueWind Medical’s Revi System, a minimally invasive Tibial NeuroModulation device for urgency urinary incontinence (UUI). Over 24 months, 79% of participants experienced at least a 50% reduction in UUI episodes, with 28% achieving complete dryness, while patient satisfaction remained high at 97%.

The Revi System offers a patient-friendly alternative to traditional neuromodulation devices, eliminating the need for frequent battery replacements and invasive surgeries. Supported by updated clinical guidelines, these findings highlight Revi’s potential as a durable, non-pharmacologic solution for UUI, improving both symptom management and quality of life.

Elinzanetant found safe and effective for VMS linked to breast cancer treatment

A phase 3 study published by Bayer on January 9, 2025, confirms the safety and efficacy of elinzanetant for treating moderate to severe vasomotor symptoms (VMS) associated with breast cancer therapy. As a dual neurokinin-1 and 3 receptor antagonist, elinzanetant offers a non-hormonal option for women experiencing VMS because of adjuvant endocrine therapy, a population with no approved treatment options.

The OASIS 4 trial demonstrated significant reductions in VMS frequency and severity by weeks 4 and 12, along with improvements in sleep and menopause-related quality of life. These findings support elinzanetant’s potential as a breakthrough therapy for managing VMS in women with or at high risk of hormone-receptor positive breast cancer.

New HPV vaccine shows promise in treating high-grade cervical lesions

A phase 2 clinical trial published on January 24, 2025, highlights the potential of Vvax001, a therapeutic vaccine targeting HPV16, in reducing advanced precancerous cervical lesions. The study involved 18 patients with HPV16-related grade 3 cervical intraepithelial neoplasia (CIN3), a precancerous condition that can progress to cervical cancer if untreated.

Results showed a complete response in 50% of participants, with 63% clearing HPV16. Among those with disease regression, some avoided surgery altogether. The vaccine was well tolerated, with no serious adverse effects reported. Researchers emphasize the need for larger trials to confirm Vvax001’s efficacy as a non-surgical alternative for HPV16-related CIN3.

Q1 2025 expert perspectives in ob-gyn

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

How gepotidacin offers new option for uncomplicated UTIs, with Ryan Haumschild, PharmD

The approval of gepotidacin marks a major advancement in treating uncomplicated urinary tract infections (uUTIs) in female adults and adolescents, offering a long-awaited alternative to older antibiotics. Ryan Haumschild, PharmD, MS, MBA, CPEL, vice president of pharmacy at Emory Healthcare, emphasized the importance of this new option, noting that prolonged use of existing treatments has led to antibiotic resistance.

Developed by GSK, gepotidacin is the first in a new class of oral antibiotics for uUTIs in over 20 years and has shown promising results in phase 3 trials, demonstrating non-inferiority and even superiority over nitrofurantoin in some cases. Haumschild highlighted the value of having another effective option with a different side effect profile, which could help reduce resistance and improve patient outcomes.

New pSNM system empowers patients in urge urinary incontinence treatment

In a recent interview with Contemporary OB/GYN, Jannah Thompson, MD, FPMRS, from Trinity Health Urogynecology, discussed the Neuspera sacral neuromodulation system's ability to address patient involvement in their care. Thompson highlighted that the system requires patients to use an external stimulator for 2 hours each day, fostering active participation and long-term commitment to treatment.

While the study initially targeted urge urinary incontinence, the therapy showed potential benefits for a broader range of patients, including those with mixed incontinence. The device is currently under FDA review, with Thompson expressing excitement over its potential to improve patient outcomes.

Mirvie's RNA platform revolutionizes detection of fetal growth restriction

In a recent interview with Contemporary OB/GYN, Kara Rood, a maternal-fetal medicine specialist at The Ohio State University, discussed Mirvie's RNA platform for early detection of fetal growth restriction (FGR). Rood explained that FGR can lead to serious complications, but traditional methods often detect it too late in pregnancy, limiting intervention options.

Mirvie’s RNA platform, using a simple maternal blood sample, can detect FGR much earlier by analyzing RNA from both the placenta and fetus, offering a proactive approach to managing pregnancy risks. Rood emphasized the potential of this technology to improve outcomes by enabling early interventions and personalized care for mothers and babies.