Use of Selective Serotonin Reuptake Inhibitors During Pregnancy and Prevalence of Congenital Malformations: A Protocol for Systematic Review and Meta-analysis of Observational Studies from 2009-2020.

Abstract

Abstract Background: The effect of antidepressants on the foetus is of great public concern on account of teratogenicity. However, evidence on this is quite controversial. This study aims to determine the risk of congenital malformations in offsprings of pregnant women placed on Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy compared to the offsprings of pregnant women not on SSRIs. It also aims to assess if significant increase in risk occurs across trimesters. METHODS AND ANALYSIS:A search strategy is developed using MeSH, text words and entry terms. Nine databases will be searched: PubMed, Embase, CINAHL, AJOL, Google Scholar, Web of Science, Cochrane Library, Research gate and Scopus. Only Observational studies from 2009-2020, retrievable in the English Language will be included. The primary measurable outcome is risk of teratogenicity with SSRI use in pregnancy. All identified studies, imported into End note version 9, will be screened based on the inclusion/exclusion criteria; data will be exported into Microsoft excel. Extractable data will include first author’s name and year of publication, proportion of congenital malformations in women on SSRIs and women without SSRIs, trimester, time of initiation and duration of treatment. Pedro quality scores and Cochrane risk of bias for individual study will be reported. All studies will be assessed for methodological, clinical and statistical heterogeneity. Publication bias will be assessed using the funnel plot. Subgroup analysis will be performed. The different trimesters and time of initiation of treatment will be used as moderators. Meta-regression will be done using duration of treatment. The CMA version 3 will be used for statistical analysis and forest plots. Discussion:The study will require no ethical approval, it is based on published data. The results obtained from this review will provide relevant information on the use of SSRIs in pregnancy and the risk of congenital malformations. Furthermore, it will provide vital information on the levels and trend of risk at each trimester. The final report will be made available to mental health experts providing care to pregnant women.Trial Registration Number: This protocol is registered in PROSPERO, with number CRD42020213505