Gestational diabetes mellitus and intrahepatic cholestasis of pregnancy – does metformin treatment affect the course of ICP: results of an observational case-control study
Abstract
Abstract Objective: To evaluate the association between metformin treatment in gestational diabetes mellitus and severity of intrahepatic cholestasis of pregnancy (ICP). Design: Retrospective multicentre cohort study. Setting: Six hospitals across the United Kingdom. Population: Pregnant women diagnosed with ICP and GDM treated with metformin. Methods: Data were obtained from one cohort collected between 1995 and 2025. ICP severity was classified based on total serum bile acid (TSBA) concentration. Participants were stratified and divided into two subgroups based on the timing of metformin initiation (before or after ICP diagnosis). TSBA trajectories were analysed using linear regression. Additional comparisons were performed between the study group and ICP cases without GDM using segmented regression to assess differences in TSBA concentrations. Main outcome measures: ICP severity and perinatal outcomes. Results: Twenty-eight cases met inclusion criteria. ICP was mild in 32.1%, moderate in 39.3%, and severe in 28.6%. Preterm birth occurred in 35.7% with no stillbirths observed. Metformin was initiated before ICP diagnosis in 56% and after diagnosis in 44% of cases. No severe ICP cases occurred in subgroup in which metformin was commenced before ICP, whereas 72.7% were severe when metformin was initiated after ICP diagnosis. Earlier ICP diagnosis (p=0.004) and higher peak TSBA (p=0.0001) were observed in the subgroup with ICP diagnosed prior to metformin commencement.…
How strong is the evidence?
Evidence Hub reads this as a case-control, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause.
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