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Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials.

ABSTRACT: Investigators are employing unprecedented innovation in the design of clinical trials to rapidly and rigorously assess potentially promising therapies for coronavirus disease 2019 (COVID-19); this is in stark contrast to the continued near-universal regressive practice of exclusion of pregnant and breastfeeding women from these trials. The few trials that allow their inclusion focus on postexposure prophylaxis or outpatient treatment of milder disease, limiting the options available to pregnant women with severe COVID-19 to compassionate use of remdesivir, or off-label drug use of hydroxychloroquine or other therapies. These restrictions were put in place despite experience with these drugs in pregnant women. In this Viewpoint, we call attention to the need and urgency to engage pregnant women in COVID-19 treatment trials now in order to develop data-driven recommendations regarding the risks and benefits of therapies in this unique but not uncommon population.

SUBMITTER: LaCourse S

PROVIDER: S-EPMC7184504 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAlthough mass vaccination against COVID-19 may prove to be the most efficacious end to this deadly pandemic, there remain concern and indecision among the public toward vaccination. Because pregnant and reproductive-aged women account for a large proportion of the population with particular concerns regarding vaccination against COVID-19, this survey aimed at investigating their current attitudes and beliefs within our own institution.ObjectiveThis study aimed to understand vaccine acceptability among pregnant, nonpregnant, and breastfeeding respondents and elucidate factors associated with COVID-19 vaccine acceptance.Study designWe administered an anonymous online survey to all women (including patients, providers, and staff) at our institution assessing rates of acceptance of COVID-19 vaccination. Respondents were contacted in 1 of 3 ways: by email, advertisement flyers, and distribution of quick response codes at virtual town halls regarding the COVID-19 vaccine. Based on their responses, respondents were divided into 3 mutually exclusive groups: (1) nonpregnant respondents, (2) pregnant respondents, and (3) breastfeeding respondents. The primary outcome was acceptance of vaccination. Prevalence ratios were calculated to ascertain the independent effects of multiple patient-level factors on vaccine acceptability.ResultsThe survey was administered from January 7, 2021, to January 29, 2021, with 1012 respondents of whom 466 (46.9%) identified as non-Hispanic White, 108 (10.9%) as non-Hispanic Black, 286 (28.8%) as Hispanic, and 82 (8.2%) as non-Hispanic Asian. The median age was 36 years (interquartile range, 25-47 years). Of all the respondents, 656 respondents (64.8%) were nonpregnant, 216 (21.3%) were pregnant, and 122 (12.1%) were breastfeeding. There was no difference in chronic comorbidities when evaluated as a composite variable (Table 1). A total of 390 respondents (39.2%) reported working in healthcare. Nonpregnant respondents were most likely to accept vaccination (457 respondents, 76.2%; P<.001) with breastfeeding respondents the second most likely (55.2%). Pregnant respondents had the lowest rate of vaccine acceptance (44.3%; P<.001). Prevalence ratios revealed all non-White races except for non-Hispanic Asian respondents, and Spanish-speaking respondents were less likely to accept vaccination (Table 3). Working in healthcare was not found to be associated with vaccine acceptance among our cohort.ConclusionIn this survey study of only women at a single institution, pregnant respondents of non-White or non-Asian races were more likely to decline vaccination than nonpregnant and breastfeeding respondents. Working in healthcare was not associated with vaccine acceptance.

Project description:IntroductionEvidence on perinatal mental health during the coronavirus disease 2019 (COVID-19) pandemic and its potential determinants is limited. Therefore, this multinational study aimed to assess the mental health status of pregnant and breastfeeding women during the pandemic, and to explore potential associations between depressive symptoms, anxiety, and stress and women's sociodemographic, health, and reproductive characteristics.Material and methodsA cross-sectional, web-based study was performed in Ireland, Norway, Switzerland, the Netherlands, and the UK between 16 June and 14 July 2020. Pregnant and breastfeeding women up to 3 months postpartum who were older than 18 years of age were eligible. The online, anonymous survey was promoted through social media and hospital websites. The Edinburgh Depression Scale (EDS), the Generalized Anxiety Disorder seven-item scale (GAD-7), and the Perceived Stress Scale (PSS) were used to assess mental health status. Regression model analysis was used to identify factors associated with poor mental health status.ResultsIn total, 9041 women participated (including 3907 pregnant and 5134 breastfeeding women). The prevalence of major depressive symptoms (EDS ≥ 13) was 15% in the pregnancy cohort and and 13% the breastfeeding cohort. Moderate to severe generalized anxiety symptoms (GAD ≥ 10) were found among 11% and 10% of the pregnant and breastfeeding women. The mean (±SD) PSS scores for pregnant and breastfeeding women were 14.1 ± 6.6 and 13.7 ± 6.6, respectively. Risk factors associated with poor mental health included having a chronic mental illness, a chronic somatic illness in the postpartum period, smoking, having an unplanned pregnancy, professional status, and living in the UK or Ireland.ConclusionsThis multinational study found high levels of depressive symptoms and generalized anxiety among pregnant and breastfeeding women during the COVID-19 outbreak. The study findings underline the importance of monitoring perinatal mental health during pandemics and other societal crises to safeguard maternal and infant mental health.

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Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials.

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