Gestational diabetes & diabetes in pregnancy
Metformin Use in the First Trimester of Pregnancy and Risk for Nonlive Birth and Congenital Malformations: Emulating a Target Trial Using Real-World Data
Main finding · Nonlive birthResult — go to the resultRisk ratio 1.02 95% CI 1.01–1.04Authors' conclusion
Compared with switching to insulin monotherapy, continuing metformin and adding insulin in early pregnancy resulted in little to no increased risk for nonlive birth among women receiving metformin before pregnancy. Under conventional statistical criteria, anything between a 49% decrease and a 9% increase in risk for congenital malformations was highly compatible with our data.
Study context
- Population
- Pregnant women with pregestational T2D on metformin monotherapy before the last menstrual period (LMP), U.S. Medicaid database (2000 to 2018)met eligibility criteria
- Participants
- 12,489 women
- Exposure
- Insulin plus metformin vs insulin monotherapy
- Insulin plus metforminn = 1,557
- Insulin monotherapyn = 850reference
- Outcome
- Nonlive birth
Methodological detailsstandardization to adjust for covariates
- Standardization to adjust for covariates
Main finding
As reported in the abstract
Risk ratio
1.02
95% CI 1.01–1.04
By group
Insulin plus metforminvs Insulin monotherapy
risk ratio 1.02 (95% CI 1.01–1.04)
Observational data: associations, not effects.
Further findings
| Outcome | Insulin monotherapy | Insulin plus metformin | Risk ratio (CI) | |
|---|---|---|---|---|
| Live birth with congenital malformations | 8.0% (CI 5.7%–10.2%) | 5.7% (CI 4.5%–7.3%) | 0.72 (0.51–1.09) | |
| 0.512Risk ratio (log scale) |
Original publication
Metformin Use in the First Trimester of Pregnancy and Risk for Nonlive Birth and Congenital Malformations: Emulating a Target Trial Using Real-World Data. Ann Intern Med. Published 18 June 2024. doi:10.
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