Gestational diabetes & diabetes in pregnancy

Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy

N Engl J MedPublished Randomised controlled trial

Primary result · Composite adverse neonatal outcomeResult — go to the resultAdjusted risk difference −5.6 percentage points 95% CI −10.1 to −1.2

Authors' conclusion

Immediate treatment of gestational diabetes before 20 weeks' gestation led to a modestly lower incidence of a composite of adverse neonatal outcomes than no immediate treatment; no material differences were observed for pregnancy-related hypertension or neonatal lean body mass.

Study context

Population
Women between 4 weeks' and 19 weeks 6 days' gestation with a risk factor for hyperglycemia and GDM (WHO 2013 criteria); initial OGTT at mean 15.6±2.5 weeks793 with follow-up data
Participants
802 participants
Comparison
Immediate treatment of GDM vs deferred or no treatment
  • Immediate treatmentn = 406
  • Controln = 396reference
Primary endpoint
Three primary outcomes: composite of adverse neonatal outcomes (birth <37 weeks, birth trauma, birth weight ≥4500 g, respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia); pregnancy-related hypertension (preeclampsia, eclampsia, or gestational hypertension); neonatal lean body mass
Methodological details1:1 randomisation
  • 1:1 randomisation

Primary result

Composite adverse neonatal outcome

Adjusted risk difference

−5.6 percentage points

95% CI −10.1 to −1.2

Events by treatment group

Immediate treatmentvs Control
adjusted risk difference −5.6 percentage points (95% CI −10.1 to −1.2)

As reported in the abstract

Further findings

OutcomeImmediate treatmentControlAdjusted risk difference (percentage points) (95% CI)
Pregnancy-related hypertension (primary outcome)10.6%9.9%0.7 (−1.6 to 2.9)

Mean, kg

OutcomeImmediate treatmentControlAdjusted mean difference (kg) (95% CI)
Neonatal lean body mass (primary outcome)2.862.91−0.04 (−0.09 to 0.02)
  • Pregnancy-related hypertension (primary outcome): Immediate treatment: 40 of 378; Control: 37 of 372

Safety

No between-group differences in serious adverse events associated with screening and treatment

Original publication

Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy. N Engl J Med. Published 5 May 2023. doi:10.1056/nejmoa2214956

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