A multicenter, randomized trial of treatment for mild gestational diabetes
- PMID: 19797280
- PMCID: PMC2804874
- DOI: 10.1056/NEJMoa0902430
A multicenter, randomized trial of treatment for mild gestational diabetes
Abstract
Background: It is uncertain whether treatment of mild gestational diabetes mellitus improves pregnancy outcomes.
Methods: Women who were in the 24th to 31st week of gestation and who met the criteria for mild gestational diabetes mellitus (i.e., an abnormal result on an oral glucose-tolerance test but a fasting glucose level below 95 mg per deciliter [5.3 mmol per liter]) were randomly assigned to usual prenatal care (control group) or dietary intervention, self-monitoring of blood glucose, and insulin therapy, if necessary (treatment group). The primary outcome was a composite of stillbirth or perinatal death and neonatal complications, including hyperbilirubinemia, hypoglycemia, hyperinsulinemia, and birth trauma.
Results: A total of 958 women were randomly assigned to a study group--485 to the treatment group and 473 to the control group. We observed no significant difference between groups in the frequency of the composite outcome (32.4% and 37.0% in the treatment and control groups, respectively; P=0.14). There were no perinatal deaths. However, there were significant reductions with treatment as compared with usual care in several prespecified secondary outcomes, including mean birth weight (3302 vs. 3408 g), neonatal fat mass (427 vs. 464 g), the frequency of large-for-gestational-age infants (7.1% vs. 14.5%), birth weight greater than 4000 g (5.9% vs. 14.3%), shoulder dystocia (1.5% vs. 4.0%), and cesarean delivery (26.9% vs. 33.8%). Treatment of gestational diabetes mellitus, as compared with usual care, was also associated with reduced rates of preeclampsia and gestational hypertension (combined rates for the two conditions, 8.6% vs. 13.6%; P=0.01).
Conclusions: Although treatment of mild gestational diabetes mellitus did not significantly reduce the frequency of a composite outcome that included stillbirth or perinatal death and several neonatal complications, it did reduce the risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and hypertensive disorders. (ClinicalTrials.gov number, NCT00069576.)
2009 Massachusetts Medical Society
Conflict of interest statement
No potential conflict of interest relevant to this article was reported.
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Comment in
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Gestational diabetes--whom do we treat?N Engl J Med. 2009 Oct 1;361(14):1396-8. doi: 10.1056/NEJMe0907617. N Engl J Med. 2009. PMID: 19797287 No abstract available.
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ACP Journal Club. Treatment of mild gestational diabetes did not prevent neonatal complications but reduced fetal overgrowth.Ann Intern Med. 2010 Jan 19;152(2):JC1-6. doi: 10.7326/0003-4819-152-2-201001190-02006. Ann Intern Med. 2010. PMID: 20083821 No abstract available.
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Treatment for mild gestational diabetes.N Engl J Med. 2010 Jan 28;362(4):365-6; author reply 366-7. doi: 10.1056/NEJMc0910810. N Engl J Med. 2010. PMID: 20107225 No abstract available.
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Treatment for mild gestational diabetes.N Engl J Med. 2010 Jan 28;362(4):366; author reply 366-7. N Engl J Med. 2010. PMID: 20112447 No abstract available.
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Gestational diabetes mellitus: can we reach consensus?Curr Diab Rep. 2010 Aug;10(4):252-4. doi: 10.1007/s11892-010-0117-3. Curr Diab Rep. 2010. PMID: 20443085 No abstract available.
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