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Carrie B. Hruska, PhD, is a medical physicist at Mayo Clinic.

Carrie B. Hruska, PhD highlights how molecular breast imaging can reveal up to 2.5 times more invasive breast cancers than mammography alone.

Carrie Hruska, PhD, highlights how MBI improves dense breast cancer detection

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She joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio, before joining 

 You can reach her at mebert@mjhlifesciences.com.

Women undergoing mastectomy face greater risks of emotional distress, physical symptoms, and reduced quality of life compared with breast-conserving procedures.

Mastectomy linked to greater emotional and physical burden

Supplemental molecular breast imaging more than doubled invasive cancer detection rates in women with dense breasts.

Supplemental molecular breast imaging improves cancer detection in dense breasts

Review some of the top stories from the Contemporary OB/GYN website over the past week and catch up on anything you may have missed.

Contemporary OB/GYN week in review: vaccine confidence, HRT, and more

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A recent clinical study presented by Koji Ishikawa, MD, PhD, orthopedic spine surgeon at Duke University, and Tony M. Keaveny, PhD, Founder and Chief Science Officer of O.N. Diagnostics, compared the effects of romosozumab, teriparatide, and denosumab on bone strength in patients with osteoporosis. 

The analysis focused on the hip and spine, where fracture risk is particularly great. Results showed that romosozumab provided substantially greater improvements in bone strength after 1 year of treatment compared to the other 2 drugs. At the spine, for example, romosozumab increased bone density by approximately 25% but boosted bone strength by about 40%, highlighting that strength gains are not fully reflected by bone density measurements from standard DXA scans.

The findings are significant because fracture prevention depends more on improved breaking strength than on density alone. Data from real-world clinical care also suggest even greater percentage gains than those seen in earlier phase-2 and phase-3 trials. 

Notably, romosozumab demonstrated the unique ability to transform highly osteoporotic vertebrae into bones at much lower risk of biomechanical failure, as shown through virtual stress testing models. According to the researchers, romosozumab stands out as the most effective treatment for strengthening both hip and spine bones, offering a compelling advantage over teriparatide and denosumab.

Below, Keaveny shares further details on their presentation 

”(SUN-416) Greater increase in bone strength with romosozumab vs teriparatide or denosumab in women with postmenopausal osteoporosis in real-world clinical setting

 and Ishikawa provides an overview of the presentation 

“(SUN-564) Greater increases in bone strength estimates of virtual bone-implant constructs for spinal surgery with romosozumab vs teriparatide or denosumab in women with postmenopausal osteoporosis”. 

Please provide an overview of your presentation about bone strength from romosozumab vs teriparatide or denosumab.

This study compared the breaking strength of the hip and spine bones for different osteoporosis drug treatments and showed that the strength benefits after 1 year of treatment were substantially greater for romosozumab compared to both teriparatide and denosumab.

Spinal instrumentation remains challenging in patients with bone fragility. The concept behind this project is to provide additional support for achieving favorable surgical outcomes, beyond surgical techniques. Based on simulation-based biomechanical analysis, we found that romosozumab offered multiple advantages over denosumab and teriparatide in terms of biomechanical parameters relevant to spinal surgery.

What is the significance of these findings?

Changes in bone density as measured by clinical-standard DXA testing are difficult to interpret because what matters most in terms of fracture reduction is how much the 

 changes. This study is significant because it demonstrates the substantial benefits for breaking strength – more than for bone density. For example, at the spine, romosozumab increased bone density by about 25% but bone strength by about 40%. So, the benefits of the treatment are underestimated when measured by bone density. And of course, those benefits were greater for romosozumab than either of the other 2 treatments.

Evaluating mechanical parameters such as screw fixation strength or bone-breaking force in clinical practice for assessing drugs effects is impractical and often difficult with traditional biomechanical methods. To address this, we developed a simulation approach using patient CT data. Our findings provide a new perspective on their effectiveness in the context of implant surgery.

What were the main takeaways of your presentation?

As we have seen in other clinical trials, romosozumab is the better treatment in terms of its bone-strengthening benefits, both at the hip and spine. Here we have data from actual clinical care.

After 1 year of treatment, romosozumab showed greater improvements than denosumab and teriparatide in surgical instrumentation-related biomechanical analyses.

What other research about the impact of romosozumab on bone strength would you like to highlight?

These results suggest even greater gains, percentage-wise at least, for these highly osteoporotic and treatment-naïve patients from clinical care than what we observed in a prior phase-2 BCT study in women with low bone mass (Keaveny JBMR 2017) and also in a phase-3 imaging substudy of osteoporotic women with prior bisphosphonate therapy (Langdahl Lancet 2017).

In a previous study, we were the first to demonstrate the potential benefits of short-term romosozumab treatment (3 months) in reducing postoperative complications after spinal surgery (Ishikawa K, JOR Spine 2024). Taken together with the present findings, our research further supports the role of romosozumab for surgical support.

These results are particularly compelling at the spine for romosozumab because the drug benefit is so large — it takes a highly osteoporotic bone and transforms it into one at much lower risk of biomechanical failure. This is seen visually with the virtual stress testing. Here, virtual forces are placed on the bone that would normally fracture and crush an osteoporotic bone. After treatment with romosozumab, that same level of force produces almost no damage in the bone. Romosozumab appears to be the only drug treatment that can transform the osteoporotic vertebra in this way.

Even the best surgeons face complications when patients have osteoporosis. Yet perioperative bone health care is often overlooked. Our studies underscore the importance of assessing and managing bone health in perioperative settings to improve surgical outcomes.

Recent work presented at the 2025 annual meeting of American Society of Bone & Mineral Research found that romosozumab significantly outperformed teriparatide and denosumab in improving hip and spine bone strength. 

Clinical

Romosozumab outperforms teriparatide and denosumab in bone strength

As we near the finish of 2025, the third quarter (Q3) 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. 

 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.

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 of acetaminophen during pregnancy to a 20% to 30% increased risk of autism spectrum disorder and attention-deficit/hyperactivity disorder in offspring, though causality remains unproven. In parallel, the FDA approved leucovorin calcium (Wellcovorin) for cerebral folate deficiency (CFD), 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 the FDA to evaluate the full new drug application, supported by three 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 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.

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 

. 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 the results of the phase 3 OASIS-3 trial published in 

. Among 628 participants randomly assigned 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 nonhormonal option for VMS management.

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

In July 2025, the American College of Obstetricians and Gynecologists (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 vs 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.

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

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

Elinzanetant

The recently published 52-week OASIS-3 trial evaluated the safety and efficacy of elinzanetant, a nonhormonal 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 improvements in the frequency and severity of 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

Special Report: Advances in STI Screening and Treatments

 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 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.

Take a quick look at everything you may have missed during the third quarter of 2025, including the latest FDA approvals, top stories, and exclusive interviews.

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

On October 2, 2025, the FDA approved another generic version of mifepristone tablets, 200 mg, submitted by Evita Solutions, LLC. The approval, issued under an abbreviated new drug application in 2021, confirms the product is "bioequivalent and therapeutically equivalent" to Mifeprex (mifepristone) 200 mg, marketed by Danco Laboratories.

Mifepristone, in combination with misoprostol, is indicated for the medical termination of intrauterine pregnancy through 70 days of gestation. The generic version will be subject to the existing Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program, a single, shared system that includes Elements to Assure Safe Use and an implementation system.

The FDA emphasized that the generic product must comply with all REMS requirements prior to entering interstate commerce. Evita Solutions’ final proposed REMS was approved in April 2025, and the product will now be included in the Mifepristone REMS Program.

The approval marks a significant regulatory milestone by expanding access to a generic version of mifepristone while maintaining strict safety protocols.

This is a developing story and will continue to be updated.

ANDA approval. FDA. September 30, 2025. Accessed October 2, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216616s000ltr.pdf

On October 2, 2025, the FDA approved a generic version of mifepristone to be used in a regimen with misoprostol for abortion.

FDA approves generic mifepristone tablet for abortion

American Journal of Obstetrics & Gynecology

 risks compared with methyldopa or nifedipine, though all 3 oral antihypertensives remain broadly safe and effective.

Hypertensive disorders of pregnancy (HDP), including chronic hypertension, gestational hypertension, and preeclampsia, affect approximately 10% of pregnancies and increase the risk of adverse maternal and neonatal outcomes. Oral antihypertensives such as methyldopa, labetalol, and nifedipine are commonly used, but head-to-head comparisons remain limited.

"Consequently, it is relevant to reanalyze existing data on the effects of oral antihypertensive agents in pregnancy on mother and child," wrote investigators.

The systematic review and network meta-analysis was conducted to compare the impacts of nifedipine, labetalol, and methyldopa on maternal and neonatal outcomes in pregnancies impacted by HDP. Randomized trials comparing these oral agents were included in the analysis. 

 such as severe hypertension, preeclampsia, eclampsia, maternal mortality, preterm birth, birthweight, small-for-gestational-age infants, Apgar scores, or neonatal death. Data were pooled using a random-effects network meta-analysis to capture direct and indirect comparisons.

Study durations ranged from early pregnancy until delivery, with participants receiving 1 of the 3 study antihypertensive agents. Risk of bias was evaluated using Cochrane criteria, with most studies classified as low to moderate quality.

The analysis included 26 trials with 4439 participants, with treatment starting between 11 and 35 weeks' gestation. Overall, oral antihypertensives were well tolerated, and maternal blood pressure was effectively controlled across all agents.

Both labetalol and methyldopa reduced the risk of severe hypertension vs placebo, with relative risks (RR) of 

Labetalol had an RR of developing preeclampsia of 0.50, highlighting a 50% reduction in risk compared with nifedipine. 

Rates of eclampsia and maternal mortality were low and comparable across treatments.

The rates of birthweight, low birthweight, and small-for-gestational-age infants were similar among all agents. 

Labetalol was associated with a modest reduction in the rate of 

 before 37 weeks compared with nifedipine, with an RR of 0.68. 

Severe prematurity, low Apgar scores, and neonatal mortality were comparable.

These results indicated that while labetalol may offer a small benefit in certain maternal and neonatal outcomes, methyldopa and nifedipine remain safe and effective alternatives. Investigators recommended that patients receive tailored therapy based on patient-specific factors such as comorbidities, drug tolerance, and clinical context.

"Future research should focus on analyzing retrospective real-life hospital data to further investigate the preferences among methyldopa, labetalol, and nifedipine in relation to maternal and fetal/neonatal morbidity and mortality in treating HDP," wrote investigators.

The importance of improved preeclampsia management is highlighted by the limitations of current guidelines, as discussed by Thomas McElrath, MD, PhD, vice president of clinical development at Mirvie, in an interview with Contemporary OB/GYN

 A study conducted by McElrath identified a moderate or high-risk criteria for preeclampsia in 89% of pregnant patients.

"Our concern is that if 89% of the population is at risk, it's going to be very hard to be personalized and individual about the approach to prophylaxis," said  McElrath.

Preeclampsia

Hup RJ, Damen JAA, Terstappen J, et al. Oral antihypertensive treatment during pregnancy: a systematic review and network meta-analysis. 

2025;233(4):250-262. doi:10.1016/j.ajog.2025.04.011

McElrath T. Thomas McElrath, MD, PhD, highlights limitations of current preeclampsia guidelines. Contemporary OB/GYN. July 17, 2025. Accessed October 2, 2025. https://www.contemporaryobgyn.net/view/thomas-mcelrath-md-phd-highlights-limitations-of-current-preeclampsia-guidelines

A review found labetalol demonstrates modest benefits in reducing preeclampsia and preterm birth in hypertensive pregnancies.

Labetalol shows advantage over methyldopa and nifedipine in hypertensive pregnancies

The need for COVID-19 vaccination during pregnancy has been unrecognized by 

 of US adults, according to a recent study by the University of Pennsylvania.

Only 38% of survey respondents indicated they would recommend pregnant patients receive the COVID-19 vaccine, and fewer women than men expressed belief that the vaccine is safe during pregnancy. This highlighted increasing controversy about vaccination use to protect pregnant women and their infants following updated recommendations in May 2025.

“Even though those in charge of the CDC have withdrawn its support for COVID-19 vaccination during pregnancy, the science showing the value of that vaccination has not changed,” said Kathleen Hall Jamieson, PhD, director of the Annenberg Public Policy Center.

Survey results highlight gender and age gaps

The survey was conducted in August 2025 and included approximately 1700 US adults. Based on the responses, 

 years believed it is false to say the COVID-19 vaccine is safe during pregnancy vs 20% of other adults. For the mRNA vaccine, these rates were 36% and 45%, respectively.

Overall, only 42% of surveyed adults believed that COVID-19 vaccination is safe during pregnancy. Investigators also highlighted a significant rise in reproductive-aged women believing it is false to state the vaccine is safe during pregnancy, from 19% in April 2024 to 28% in August 2025.

Knowledge about the COVID-19 vaccine during pregnancy was also assessed. Correctly identifying the vaccine’s efficacy toward reducing hospitalization risk with COVID-19 was reported by 52% of patients, but 29% were not sure of this association and 

Additionally, the odds of correctly identifying that vaccination protects against hospitalization were reduced in reproductive-aged women. Rates for this belief were only 43% among this population vs 55% among other adults.

Only 51% of respondents knew that the risks of COVID-19 complications impacting pregnancy are reduced by the COVID-19 vaccine. Thirty percent of respondents were unsure about this association, and 20% believed this statement is false.

Reduced belief in this association has also been reported, with a rate of 57% in April 2024. No significant differences were reported between reproductive-aged women in the general population.

A survey reveals declining confidence in COVID-19 vaccination during pregnancy, with fewer adults recommending it despite scientific evidence.

Carrie B. Hruska, PhD

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