Gestational diabetes & diabetes in pregnancy
Early Metformin in Gestational Diabetes: A Randomized Clinical Trial
Authors' conclusion
Early treatment with metformin was not superior to placebo for the composite primary outcome. Prespecified secondary outcome data support further investigation of metformin in larger clinical trials.
Study context
- Population
- Individuals with GDM by World Health Organization 2013 criteria, 2 centres in Ireland (one tertiary, one smaller regional hospital); enrolled June 2017–September 2022; mean age 34.3 years535 pregnancies randomized
- Participants
- 510 individuals
- Comparison
- Early metformin vs placebo, in addition to usual care
- Primary endpoint
- Composite of:
- Insulin initiation
- Fasting glucose ≥5.1 mmol/L
- Follow-up
- Gestation weeks 32 or 38
Methodological detailsdouble-blind, placebo-controlled, 2 centres, Followed up until 12 weeks' postpartum
- Double-blind
- Placebo-controlled
- 2 centres
- Followed up until 12 weeks' postpartum
Primary result
As reported in the abstract
Each group vs placeboBetween-group difference (95% CI)P value
Metformin
−6.9%(−15.1% to 1.4%)
P = 0.13Each group vs placeboRelative risk (95% CI)P value
Metformin
0.89(0.78–1.02)
P = 0.13Secondary outcomes
Prespecified secondary maternal outcomes
- Of 6 prespecified secondary maternal outcomes, 3 favored metformin: time to insulin initiation, self-reported capillary glycemic control and gestational weight gain
- 3 of 6
Secondary neonatal outcomes: neonatal size
- Smaller neonates with metformin: lower mean birth weights, lower proportion >4 kg, lower proportion >90% percentile, smaller crown-heel length
Safety
Neonatal complications
- No differences in neonatal intensive care needs, respiratory distress requiring respiratory support, jaundice requiring phototherapy, major congenital anomalies, neonatal hypoglycemia, or 5-minute Apgar <7
Original publication
Early Metformin in Gestational Diabetes: A Randomized Clinical Trial. JAMA. Published 24 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →