Effects of metformin use in pregnant women on maternal and infant outcomes: protocol for a systematic review and meta-analysis

ABSTRACT Introduction Metformin has been considered for use in women who are overweight or obese and with pre-existing type 2 diabetes(T2DM) or gestational diabetes mellitus(GDM). Nevertheless, few studies have weighed the pros and cons of maternal metformin use on offspring and women’s perinatal health. We determined to ascertain whether the insulin sensitiser metformin improves fetal and maternal outcomes in Pregnant women with type 2 diabetes or with a BMI no less than 24 kg/m 2 Methods and analysis The protocol was formulated according to Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Exhaustive literature searches of electronic bibliographic databases will be conducted in PubMed, EMBASE, Cochrane Library, Web of Sciences, Scopus, ClinicalTrial, OvidSP and ScienceDirect. We used a predefined data extraction table to perform data extraction, and publication bias measurement for each study will be accomplished through the Cochrane Collaboration Tool. The statistical analyses will be performed using RevMan (5.4.1; The Cochrane Collaboration) and STATA (17). Heterogeneity will be assessed using the Q and I 2 test, with a value of I 2 > 50% being considered substantial. The extent of publication bias will be investigated by visual assessment of a funnel plot and using Egger’s test, Begg’s test, and Harbord’s test if ten or more trials are pooled. Ethics and dissemination Patients’ consent and Ethical approval are not requisites. The complete analysis will be published in an international open-access journal and translational articles to disseminate the results to clinical internists. PROSPERO registration number: CRD42022347084 Strengths and limitations of this study ▸ This review will comprehensively assess published English-language studies without period or geographical restrictions. ▸ This system review plan strictly follows preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) ▸ Included studies will be limited to RCTs, which have a high degree of internal consistency and are not representative of the real world. ▸ As is the case with most meta-analyses, there may be significant and unexplained heterogeneity in this study.