A multicenter, randomized trial of treatment for mild gestational diabetes.

Full 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

Author information

Author/s: Landon, Mark B (MB); Spong, Catherine Y (CY); Thom, Elizabeth (E); Carpenter, Marshall W (MW); Ramin, Susan M (SM); Casey, Brian (B); Wapner, Ronald J (RJ); Varner, Michael W (MW); Rouse, Dwight J (DJ); Thorp, John M (JM); Sciscione, Anthony (A); Catalano, Patrick (P); Harper, Margaret (M); Saade, George (G); Lain, Kristine Y (KY); Sorokin, Yoram (Y); Peaceman, Alan M (AM); Tolosa, Jorge E (JE); Anderson, Garland B (GB); Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network;

Affiliation: Department of Obstetrics and Gynecology, Ohio State University, Columbus, USA. mark.landon(-atsign-)osumc.edu

Grants: C06-RR11234 (Agency:NCRR NIH HHS) ; HD21410 (Agency:NICHD NIH HHS) ; HD27860 (Agency:NICHD NIH HHS) ; HD27869 (Agency:NICHD NIH HHS) ; HD27915 (Agency:NICHD NIH HHS) ; HD27917 (Agency:NICHD NIH HHS) ; HD34116 (Agency:NICHD NIH HHS) ; HD34136 (Agency:NICHD NIH HHS) ; HD34208 (Agency:NICHD NIH HHS) ; HD36801 (Agency:NICHD NIH HHS) ; HD40485 (Agency:NICHD NIH HHS) ; HD40500 (Agency:NICHD NIH HHS) ; HD40512 (Agency:NICHD NIH HHS) ; HD40544 (Agency:NICHD NIH HHS) ; HD40545 (Agency:NICHD NIH HHS) ; HD40560 (Agency:NICHD NIH HHS) ; HD53097 (Agency:NICHD NIH HHS) ; HD53118 (Agency:NICHD NIH HHS) ; M01-RR00034 (Agency:NCRR NIH HHS) ; M01-RR00080 (Agency:NCRR NIH HHS) ; UL1-RR024989 (Agency:NCRR NIH HHS) ; UL1-RR025764 (Agency:NCRR NIH HHS)

Journal and publication information

Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural

Journal: The New England journal of medicine (N Engl J Med), published in United States. (Language: eng)

Reference: 2009-Oct; vol 361 (issue 14) : pp 1339-48

Dates: Created 2009/10/02; Completed 2009/10/06;

PMID: 19797280, status: MEDLINE (last retrieval date: 10/6/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

Comments and Corrections

CommentIn: N Engl J Med. 2009 Oct 1;361(14):1396-8. (PMID: 19797287)

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