Background: Cholera increases the risk of harmful effects on foetuses. We prospectively followed pregnant women\nunaware of their pregnancy status who received a study agent in a clinical trial evaluating the association between\nexposure to an oral cholera vaccine (OCV) and foetal survival.\nMethods: Study participants were selected from a randomized placebo-controlled trial conducted in Dhaka, Bangladesh.\nThe vaccination campaign was conducted between January 10 and February 4, 2014. We enrolled women who were\nexposed to an OCV or placebo during pregnancy (Cohort 1) and women who were pregnant after the vaccination was\ncompleted (Cohort 2). Our primary endpoint was pregnancy loss (spontaneous miscarriage or stillbirth), and\nthe secondary endpoints were preterm delivery and low birth weight. We employed a log-binomial regression\nto calculate the relative risk of having adverse outcomes among OCV recipients compared to that among\nplacebo recipients.\nResult: There were 231 OCV and 234 placebo recipients in Cohort 1 and 277 OCV and 299 placebo recipients\nin Cohort 2. In Cohort 1, the incidence of pregnancy loss was 113/1000 and 115/1000 among OCV and placebo\nrecipients, respectively. The adjusted relative risk for pregnancy loss was 0.97 (95% CI: 0.58â??1.61; p = 0.91) in Cohort 1.\nWe did not observe any variation in the risk of pregnancy loss between the two cohorts. The risks for preterm delivery\nand low birth weight were not significantly different between the groups in both cohorts.\nConclusions: Our study provides additional evidence that exposure to an OCV during pregnancy does not increase\nthe risk of pregnancy loss, preterm delivery, or low birth weight, suggesting that pregnant women in cholera-affected\nregions should not be excluded in a mass vaccination campaign.
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