Type 2 & other diabetes

Perinatal Outcomes Associated With Metformin Use During Pregnancy in Women With Pregestational Type 2 Diabetes Mellitus

Diabetes CarePublished Target trial emulation cohort study

Main finding · Composite neonatal outcomeResult — go to the resultAdjusted relative risk 0.92 95% CI 0.81–1.03

Authors' conclusion

Our findings were consistent with those reported in the MiTy randomized trial. Continuing metformin during pregnancy was not associated with increased risk of a neonatal composite adverse outcome. However, a possible metformin-associated risk of SGA warrants further consideration.

Study context

Population
Pregnant women aged 18–45 years with T2D treated with metformin plus insulin at conception; US claims, 2000–2020; mean age at conception 32 years72% discontinued
Participants
2,983 women
Exposure
Continuing vs discontinuing metformin during pregnancy
Outcome
Composite of:
  • Preterm birth
  • Birth injury
  • Neonatal respiratory distress
  • Neonatal hypoglycemia
  • Neonatal ICU admission
Methodological detailsemulation of modified randomized trial (MiTy), two US health care claims databases, adjusted for baseline confounders
  • Emulation of modified randomized trial (MiTy)
  • Two US health care claims databases
  • Adjusted for baseline confounders

Main finding

Composite neonatal outcome

Adjusted relative risk

0.92

95% CI 0.81–1.03

By group

Continuersvs Discontinuers
adjusted RR 0.92 (95% CI 0.81–1.03)

As reported in the abstract

Observational data: associations, not effects.

Secondary outcomes

Risks similar between treatments and consistent between databases for most secondary outcomes
Small for gestational age (SGA) elevated in continuers only in the commercially insured population

Original publication

Perinatal Outcomes Associated With Metformin Use During Pregnancy in Women With Pregestational Type 2 Diabetes Mellitus. Diabetes Care. Published 23 July 2024. doi:10.2337/dc23-2056

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