Background: Metformin is increasingly used in pregnancy despite limited evidence regarding efficacy. We established the Metformin in Pregnancy Study (MiPS) individual participant data (IPD) consortium to determine the effects of metformin on pregnancy outcomes.
Methods: We searched Medline, Embase and all Evidence-based Medicine databases until May 2025, to identify double-blind randomised trials comparing metformin with placebo in high-risk pregnancies. Primary maternal outcomes were gestational diabetes (GDM) and glycaemic indices from oral glucose tolerance tests (OGTTs). Primary neonatal outcomes were gestational age at delivery, neonatal anthropometry, and hypoglycaemia. Multivariable mixed-effects models were adjusted for maternal age, body mass index, gestational age at treatment initiation and baseline blood glucose.
Findings: Ten trials (n=2695) met inclusion criteria, of which seven provided IPD (n=2482, 92·1%). Following IPD harmonisation, 2297 pregnancies (1159 metformin; 1138 placebo) were included. Metformin did not reduce GDM by any diagnostic criteria; a reduction was only seen in adjusted analysis using IADPSG/ADIPS criteria (13.5% vs 16.7%; adjusted odds ratio [aOR] 0·71; 95% CI 0·52, 0·98). Fasting blood glucose was marginally lower with metformin (mean difference [MD] -0·06 mmol/L; 95% CI -0·11, -0·02), with no difference in two-hour post-OGTT blood glucose. Gestation was longer with metformin (MD 0·29 weeks; 95% CI 0·05, 0·53), corresponding to a lower risk of preterm birth (OR 0·65; 95% CI 0·47, 0·90), and minor increase in neonatal head circumference (MD 2·53 percentile; 95% CI 0·23, 4·83). Metformin reduced gestational weight gain (MD -1·53 kg; 95% CI -2.03, -1.03), with no differences in other maternal or neonatal outcomes.