Gestational diabetes & diabetes in pregnancy
Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial
Primary result · Composite adverse neonatal outcomeResult — go to the resultAdjusted odds ratio 0.86 95% CI 0.63–1.19- halted at 75% accrual for futility
- Study halted at 75% accrual for futility
Authors' conclusion
Using metformin plus insulin to treat preexisting type 2 or gestational diabetes diagnosed early in pregnancy did not reduce a composite neonatal adverse outcome. The effect of reduction in odds of a large-for-gestational-age infant observed after adding metformin to insulin warrants further investigation.
Study context
- Population
- Pregnant adults aged 18 to 45 years with preexisting T2D or diabetes diagnosed prior to 23 weeks' gestation, 17 US centers, 2019–2021794 analysed
- Participants
- 831 adults
- Comparison
- Metformin vs placebo added to insulin
- Metforminn = 397
- Placebon = 397reference
- Primary endpoint
- Composite of:
- Neonatal complications including perinatal death
- Preterm birth
- Large or small for gestational age
- Hyperbilirubinemia requiring phototherapy
Methodological detailsplacebo-controlled, multicentre (17 US centers)
- Placebo-controlled
- Multicentre (17 US centers)
Primary result
Composite adverse neonatal outcome
Adjusted odds ratio
0.86
95% CI 0.63–1.19
Events by treatment group
Metforminvs Placebo
aOR 0.86 (95% CI 0.63–1.19)
As reported in the abstract
Secondary outcomes
| Outcome | aOR (95% CI) | |
|---|---|---|
| Large for gestational age (component of primary composite) | 0.63 (0.46–0.86) | |
| 0.512Adjusted odds ratio (log scale) |
Prespecified secondary outcomes (incl. maternal hypoglycemia, neonatal fat mass) and subgroup analyses
- Similar between groups
Original publication
Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial. JAMA. Published 12 December 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →