TOBOGM
Trial question
What is the role of immediate treatment of gestational diabetes before 20 weeks gestation?
Study design
Multi-center
Open label
RCT
Population
802 female patients.
Inclusion criteria: women between 4 weeks and 19 weeks 6 days gestation who had a risk factor for hyperglycemia and a diagnosis of gestational diabetes.
Key exclusion criteria: pre-existing diabetes; fasting glucose level ≥ 110 mg/dL; or a 2-hour glucose level ≥ 200 mg/dL.
Interventions
N=406 immediate treatment (education, dietary advice and instructions on how to monitor capillary blood glucose levels).
N=396 no treatment (no treatment or deferred treatment).
Primary outcome
Adverse neonatal outcome
24.9%
30.5%
30.5 %
22.9 %
15.3 %
7.6 %
0.0 %
Immediate
treatment
No
treatment
Significant
decrease ▼
NNT = 17
Significant decrease in adverse neonatal outcome (24.9% vs. 30.5%; RR 0.82, 95% CI 0.68 to 0.98).
Secondary outcomes
No significant difference in pregnancy-related hypertension (10.6% vs. 9.9%; RR 1.08, 95% CI 0.85 to 1.38).
No significant difference in mean neonatal lean body mass (2.86 kg vs. 2.91 kg; AD -0.04 kg, 95% CI -0.09 to 0.02).
Significant decrease in perineal injury (0.8% vs. 3.6%; RR 0.23, 95% CI 0.1 to 0.51).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In women between 4 weeks and 19 weeks 6 days gestation who had a risk factor for hyperglycemia and a diagnosis of gestational diabetes, immediate treatment was superior to no treatment with respect to adverse neonatal outcome.
Reference
David Simmons, Jincy Immanuel, William M Hague et al. Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy. N Engl J Med. 2023 Jun 8;388(23):2132-2144.
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