We report on the perinatal outcomes of pregnant patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from 2 hospitals in Montréal, Québec. Outcomes of 45 patients with SARS-CoV-2 during pregnancy were compared with those of 225 patients without infection. Sixteen percent of patients with SARS-CoV-2 delivered preterm, compared with 9% of patients without ( P = 0.28). Median gestational age at delivery (39.3 (interquartile range [IQR] 37.7–40.4) wk vs. 39.1 [IQR 38.3-40.1] wk) and median birthweight (3250 [IQR 2780-3530] g vs. 3340 [IQR 3025-3665] g) were similar between groups. The rate of cesarean delivery was 29% for patients with SARS-CoV-2. Therefore, we did not find important differences in outcomes associated with SARS-CoV-2. Our findings may be limited to women with mild COVID-19 diagnosed in the third trimester.

Despite calls over the past decades for greater inclusion of pregnant people in clinical research, their systematic exclusion remains common practice. 1 Several clinical trials investigating potential therapies for Covid-19 are underway throughout the world. 2 However, most of these trials (829/1282; 65%) enrolling people of reproductive age exclude pregnant persons or fail to address the issue of pregnancy, 3 even though, for many of the investigational therapies, safety data about their use in pregnant patients is available. 4 The exclusion of pregnant people from Covid-19 clinical trials may result in several unintended consequences. First, because of a lack of data on the safety and effectiveness of potential therapies during pregnancy, pregnant people may be untreated or inadequately treated for Covid-19. 5 Second, in the absence of adequate pharmacokinetic data, medications may be overor underdosed for pregnancy. 6 Third, investigational therapies are being used in pregnant patients outside of the purview of a clinical trial setting, 7 and thus pregnant people may be exposed to the risk of adverse events in the absence of demonstrated efficacy.The Coalition to Advance Maternal Therapeutics, which includes over 20 organizations whose shared goal is to address gaps in research on therapeutics for pregnant women, has urged the U.S. National Institutes of Health and the U.S. Food and Drug Administration to call for inclusion of pregnant women in Covid-19 trials. 8 However, to successfully broaden the inclusion of ABSTRACT Excluding pregnant people from Covid-19 clinical trials may lead to unintended harmful consequences. For this study, an online questionnaire was sent to physicians belonging to Canadian professional medical associations in order to evaluate their perspectives on the participation of pregnant women in Covid-19 clinical trials. The majority of respondents expressed support for including pregnant women in Covid-19 trials (119/165; 72%), especially those investigating therapies with a prior safety record in pregnancy (139/164; 85%). The main perceived barriers to inclusion identified were unwillingness of pregnant patients to participate and of treating teams to offer participation, the burden of regulatory approval, and a general "culture of exclusion" of pregnant women from trials. We describe why some physicians may be reluctant to include pregnant individuals in trials, and we identify barriers to the appropriate participation of pregnant people in clinical research. KEYWORDS human subjects research, Covid-19 clinical trials, pregnant research participants, research with pregnant women, maternal-fetal ethics, inclusion of pregnant women in trials

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Background Optimal obstetric management for women with coronavirus disease (COVID-19) is not known. We describe the management of six pregnant women requiring in-hospital care for severe COVID-19. Methods A retrospective chart review was conducted to identify pregnant women who tested positive for Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) between 15 March and 30 June 2020. A subset of women meeting criteria for severe COVID-19 was included. Results Four women required non-invasive supplemental oxygen therapy and two required mechanical ventilation. Four women were discharged from hospital undelivered and two required preterm delivery. One woman had a pulmonary embolism, and two required re-admission for worsening symptoms. Conclusion Management of pregnant women with severe COVID-19 is complex and should involve multidisciplinary expertise. Avoiding early delivery may be a safe option. We recommend an individualized approach to care, including careful consideration of the expected risks and benefits of expectant obstetric management versus delivery.