A multicenter, randomized trial of treatment for mild gestational diabetes. The New England journal of medicine [N Engl J Med] Journal article | | Title | A multicenter, randomized trial of treatment for mild gestational diabetes. | | Author(s) | Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB, Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network | | Institution | Department of Obstetrics and Gynecology, Ohio State University, Columbus, USA. mark.landon@osumc.edu | | Source | N Engl J Med 2009 Oct 1; 361(14):1339-48. | | MeSH | Adult
Birth Weight
Body Mass Index
Cesarean Section
Combined Modality Therapy
Diabetes, Gestational
Female
Fetal Macrosomia
Glucose Tolerance Test
Humans
Hypoglycemic Agents
Infant, Newborn
Infant, Newborn, Diseases
Insulin
Perinatal Mortality
Pregnancy
Pregnancy Outcome
Premature Birth
Stillbirth
| | 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.) | | Language | eng | | Pub Type(s) | Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
| | PubMed ID | 19797280 |
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