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BACKGROUND: In early 2023, when Omicron was the variant of concern, we showed that vaccinating pregnant women decreased the risk for severe COVID-19-related complications and maternal morbidity and mortality. OBJECTIVE: This study aimed to analyze the impact of COVID-19 during pregnancy on newborns and the effects of maternal COVID-19 vaccination on neonatal outcomes when Omicron was the variant of concern. STUDY DESIGN: INTERCOVID-2022 was a large, prospective, observational study, conducted in 40 hospitals across 18 countries, from November 27, 2021 (the day after the World Health Organization declared Omicron the variant of concern) to June 30, 2022, to assess the effect of COVID-19 in pregnancy on maternal and neonatal outcomes and to assess vaccine effectiveness. Women diagnosed with laboratory-confirmed COVID-19 during pregnancy were compared with 2 nondiagnosed, unmatched women recruited concomitantly and consecutively during pregnancy or at delivery. Mother-newborn dyads were followed until hospital discharge. The primary outcomes were a neonatal positive test for COVID-19, severe neonatal morbidity index, severe perinatal morbidity and mortality index, preterm birth, neonatal death, referral to neonatal intensive care unit, and diseases during the neonatal period. Vaccine effectiveness was estimated with adjustment for maternal risk profile. RESULTS: We enrolled 4707 neonates born to 1577 (33.5%) mothers diagnosed with COVID-19 and 3130 (66.5%) nondiagnosed mothers. Among the diagnosed mothers, 642 (40.7%) were not vaccinated, 147 (9.3%) were partially vaccinated, 551 (34.9%) were completely vaccinated, and 237 (15.0%) also had a booster vaccine. Neonates of booster-vaccinated mothers had less than half (relative risk, 0.46; 95% confidence interval, 0.23-0.91) the risk of being diagnosed with COVID-19 when compared with those of unvaccinated mothers; they also had the lowest rates of preterm birth, medically indicated preterm birth, respiratory distress syndrome, and number of days in the neonatal intensive care unit. Newborns of unvaccinated mothers had double the risk for neonatal death (relative risk, 2.06; 95% confidence interval, 1.06-4.00) when compared with those of nondiagnosed mothers. Vaccination was not associated with any congenital malformations. Although all vaccines provided protection against neonatal test positivity, newborns of booster-vaccinated mothers had the highest vaccine effectiveness (64%; 95% confidence interval, 10%-86%). Vaccine effectiveness was not as high for messenger RNA vaccines only. Vaccine effectiveness against moderate or severe neonatal outcomes was much lower, namely 13% in the booster-vaccinated group (all vaccines) and 25% and 28% in the completely and booster-vaccinated groups, respectively (messenger RNA vaccines only). Vaccines were fairly effective in protecting neonates when given to pregnant women ≤100 days (14 weeks) before birth; thereafter, the risk increased and was much higher after 200 days (29 weeks). Finally, none of the neonatal practices studied, including skin-to-skin contact and direct breastfeeding, increased the risk for infecting newborns. CONCLUSION: When Omicron was the variant of concern, newborns of unvaccinated mothers had an increased risk for neonatal death. Neonates of vaccinated mothers had a decreased risk for preterm birth and adverse neonatal outcomes. Because the protective effect of COVID-19 vaccination decreases with time, to ensure that newborns are maximally protected against COVID-19, mothers should receive a vaccine or booster dose no more than 14 weeks before the expected date of delivery.
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CONTEXT: This national needs assessment study explores the knowledge, attitude, beliefs, and practices (KABP) gaps related to vasomotor symptoms (VMS) associated with menopause among primary care and OB/GYN clinicians. VMS significantly impacts healthcare costs, workplace productivity, and patient psychosocial health, but a notable disconnect exists between healthcare providers and patients, with provider reticence and knowledge gaps playing a contributing role. OBJECTIVES: This study aims to identify and propose optimal educational strategies to address these barriers, with attention to health disparities affecting women of color. METHODS: Methods employed include a multimodal approach of literature review, expert opinion, qualitative interviews, surveys, focus groups, and case studies, ensuring diverse clinician input. Data collection involved in-depth clinician interviews, a nationally disseminated clinician survey, and focus groups. RESULTS: Results indicate a critical deficiency in healthcare providers' understanding and management of VMS, especially among OB/GYN residents, with 75â¯% showing limited knowledge. The study also highlights the disproportionate impact of knowledge gaps on women of color, emphasizing the need for a culturally informed approach in medical training and practice. There's a notable discrepancy between clinicians' current and desired abilities in managing VMS, indicating a need for ongoing professional development. Significant variability in approaches to diagnosing and treating VMS, as well as substantial knowledge gaps about treatment options, underscore the need for evidence-based protocols. CONCLUSIONS: Although VMS are a normal aspect of aging, they can significantly disrupt quality of life for many women, necessitating intervention. Beyond the immediate discomfort, VMS can impact quality of life and trigger insomnia and mood disturbances. This study exposes both new and previously recognized gaps in healthcare providers' knowledge and management skills concerning VMS treatment options, particularly regarding hormonal and nonhormonal therapies. Furthermore, our findings highlight the need for a deeper understanding of how VMS uniquely impacts women of diverse backgrounds. Research, including the Study of Women's Health Across the Nation (SWAN), suggests that the experience and severity of VMS may be influenced by socioeconomic status, race/ethnicity, body mass index (BMI), and smoking status. However, the complex interplay of these factors and their relative contributions remain unclear. Further investigation is crucial to facilitate equitable access to effective treatment for all women. To bridge these gaps, improved education starting as early as residency is essential. This education should address common misconceptions about VMS and its management. Healthcare providers must enhance their competence in discussing the broad spectrum of VMS impacts and employ effective communication strategies to ensure that patients are well-informed about their symptoms and available treatment options.