Obstetrics and gynecology最新文献

Measles is a highly contagious infectious disease caused by the measles virus. Recent declines in population-level immunity and outbreaks linked to imported cases have led to the highest U.S. incidence of measles since its elimination in 2000. Measles infection during pregnancy is associated with increased risk of pneumonia, need for respiratory support and mortality, prematurity, and stillbirth. Although perinatal transmission is rare, congenital measles is linked to higher infant mortality. No licensed antiviral therapies or curative treatments exist, making prevention critical. Measles-containing vaccines are safe and 97% effective in preventing infection when two doses are administered. Measles vaccination is contraindicated during pregnancy; obstetricians and gynecologists should strongly recommend vaccination to all nonpregnant susceptible patients.

Objective: To assess the safety of the respiratory syncytial virus prefusion F protein (RSVpreF) vaccine in pregnant women during the 2024-2025 French immunization campaign, with a particular focus on the risk of preterm birth.

Methods: Using the national health care database, which covers almost 99% of the population in France, we included all women who gave birth after 22 weeks of gestation between September 16 and December 31, 2024. Women vaccinated with RSVpreF were matched 1:1 with unvaccinated women on the basis of gestational age at vaccination, maternal age at pregnancy onset, region of residence, week of conception, history of preterm birth, influenza vaccination during the same pregnancy, and multiple pregnancy. Outcomes included preterm birth, delivery within 1 and 3 weeks after vaccination, stillbirth, small-for-gestational-age (SGA) birth weight, cesarean delivery, hemorrhage, preeclampsia, and major cardiovascular events, including maternal death. Time-to-event analyses were conducted with Poisson regression models with robust variance to estimate weighted incidence rate ratios (IRRs) and their 95% CIs for each outcome.

Results: Among the 29,032 women vaccinated during the study period, 24,891 (85.7%) were successfully matched to 24,891 unvaccinated women in a control group. In the matched cohort, the mean±SD maternal age was 30.9±5.0 years, 3.2% had a history of preterm birth, 0.6% had multiple pregnancies, and 21.8% had received influenza vaccination. No significant increase in the risk of the following outcomes was observed: preterm birth (weighted IRR 0.97, 95% CI, 0.89-1.06), delivery within 1 week (weighted IRR 0.81, 95% CI, 0.72-0.90) or within 3 weeks (weighted IRR 0.97, 95% CI, 0.93-1.00), stillbirth (weighted IRR 0.77, 95% CI, 0.45-1.32), cesarean delivery (weighted IRR 1.00, 95% CI, 0.96-1.03), SGA birth weight (weighted IRR 1.01, 95% CI, 0.96-1.07), postpartum hemorrhage (weighted IRR 1.03, 95% CI, 0.97-1.10), preeclampsia (weighted IRR 1.02, 95% CI, 0.85-1.22), or major adverse cardiovascular event (weighted IRR 0.60, 95% CI, 0.26-1.40) outcomes. Among women vaccinated at or before 32 weeks of gestation, no significant increase in the risk of preterm birth was observed (weighted IRR 1.13, 95% CI, 0.98-1.31).

Conclusion: This large observational study found no major safety concerns associated with RSVpreF vaccination during pregnancy. Further research, including international comparisons and evaluations of effectiveness relative to monoclonal antibodies against RSV, will be needed to fully characterize the benefit-risk balance of RSVpreF. Ongoing surveillance remains essential, particularly to monitor rare adverse events.

Objective: To compare the efficacy of 162 mg vs 81 mg aspirin daily for the prevention of preterm preeclampsia (less than 37 weeks of gestation) or preeclampsia with severe features among pregnant people at high risk.

Methods: We conducted a pragmatic, randomized, open-label, blinded endpoint clinical trial. Pregnant people at high risk for preeclampsia were randomized to treatment with either 162 mg or 81 mg aspirin daily beginning before 16 weeks of gestation until term and followed up until 6 weeks postpartum. The primary composite outcome of either preterm preeclampsia or preeclampsia with severe features was adjudicated by independent researchers blinded to treatment group. Secondary outcomes were the components of the composite, adherence to therapy, and maternal and neonatal complications. The anticipated incidence of the primary composite outcome in the 81-mg group was 8.6%. We calculated that enrollment of 394 participants (197 for each group) would have 80% power to detect a 7.1% reduction in the primary outcome with 162 mg aspirin compared with 81 mg, assuming a two-sided α of 0.05.

Results: Of 400 participants randomized, 365 had delivery data available and were included in the intention-to-treat analysis, with 184 participants in the 162-mg group and 181 in the 81-mg group. The incidence of preterm preeclampsia or preeclampsia with severe features was 26 of 184 (14.1%) in the 162-mg group compared with 31 of 181 (17.1%) in the 81-mg group (relative risk 0.83, 95% CI, 0.51-1.33, P =.4). Individual outcomes of preterm preeclampsia and term preeclampsia with severe features were similar between aspirin groups. Adherence rates ranged from 88% to 91% and 89% to 92% for the 162-mg group compared with the 81-mg group, respectively, across study visits. Singleton birth weight was slightly lower in the 162-mg group (2.9 kg vs 3.2 kg, P =.005). There were eight cases of placental abruption in participants randomized to 162 mg compared with 0 in those randomized to 81 mg ( P =.013).

Conclusion: Among people at increased risk for preeclampsia, the rates of preterm preeclampsia or preeclampsia with severe features were similar to rates in those randomized to treatment with either 81 mg or 162 mg aspirin at less than 16 weeks of gestation.

Clinical trial registration: ClinicalTrials.gov , NCT04070573.