Gestational diabetes & diabetes in pregnancy
Major malformations risk following early pregnancy exposure to metformin: a systematic review and meta-analysis
Authors' conclusion
Metformin use in first-trimester pregnancy in women with PCOS or PGDM do not meaningfully increase the MCM risk overall.
Study context
- Population
- Pregnant women with polycystic ovary syndrome (PCOS) or pregestational DM (PGDM); studies searched until December 202111 studies (2 RCTs, 9 cohorts)
- Comparison
- First-trimester metformin exposure vs control
- Outcome
- Major congenital malformations (MCMs)
Methodological detailsrandom-effects model, Mantel-Haenszel method, analysed separately by indication and study type
- Random-effects model
- Mantel-Haenszel method
- Analysed separately by indication and study type
Pooled result
As reported in the abstract
MCM rates
Metformin vs ControlOdds ratio (95% CI)P value
PCOS, RCTs (57 exposed, 52 control infants); I2=0%; Q test=0.31
0.93(0.09–9.21)
P = 0.58PCOS, observational (472 exposed, 1892 control infants); I2=65%; Q test=9.43
1.35(0.37–4.90)
P = 0.05PGDM, 7 observational (1122 exposed, 1851 control infants); I2=59%; Q test=16.34
1.05(0.50–2.18)
P = 0.01Original publication
Major malformations risk following early pregnancy exposure to metformin: a systematic review and meta-analysis. BMJ Open Diabetes Res Care. Published 31 January 2023. doi:10.
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