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Metformin in Pregnancy Study (MiPS): protocol for a systematic review with individual patient data meta-analysis
Aya Mousa1, Tone Løvvik2, Ijäs Hilkka3
1Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria, Australia aya.mousa@monash.edu.
BMJ Open
|May 24, 2020
Summary
This study will analyze individual patient data from randomized controlled trials to determine the safety and effectiveness of metformin for gestational diabetes mellitus (GDM) in pregnant women. Findings will clarify its use in pregnancy and identify patient subgroups who may benefit most.
Area of Science:
- Obstetrics and Gynecology
- Pharmacology
- Clinical Epidemiology
Background:
- Gestational diabetes mellitus (GDM) is a prevalent pregnancy complication linked to adverse maternal and neonatal outcomes.
- Metformin is frequently used for GDM management, but its safety and efficacy during pregnancy remain subjects of ongoing debate.
- Existing evidence is fragmented, necessitating a comprehensive analysis to guide clinical practice.
Purpose of the Study:
- To conduct an individual patient data (IPD) meta-analysis to rigorously evaluate the efficacy and safety of metformin in pregnant women with GDM.
- To identify potential knowledge gaps concerning metformin's use in pregnancy.
- To explore subgroups that may experience differential treatment benefits.
Main Methods:
- Systematic literature search of MEDLINE, EMBASE, and Evidence-Based Medicine for relevant randomized controlled trials (RCTs).
- Independent review, data extraction, and quality appraisal of eligible studies, with authors invited to contribute IPD.
- Harmonization of IPD and a two-step meta-analytic approach, including covariate and subgroup analyses, to assess primary and secondary outcomes.
Main Results:
- The study is designed to provide robust evidence on maternal glycaemic control, GDM incidence, and neonatal outcomes such as hypoglycemia and anthropometry.
- Secondary outcomes including adverse maternal, birth, and neonatal events will be assessed.
- Sensitivity analyses will address heterogeneity, risk of bias, and the impact of missing IPD.
Conclusions:
- This IPD meta-analysis is expected to yield high-quality evidence on metformin's role in managing GDM during pregnancy.
- Findings will inform clinical decision-making and public health strategies related to metformin use in pregnancy.
- The study aims to clarify treatment effectiveness and identify specific patient populations who could benefit most from metformin therapy.
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