Journal article
A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes
The New England journal of medicine, v 361(14), pp 1339-1348
01 Oct 2009
PMID: 19797280
Featured in Collection : UN Sustainable Development Goals @ Drexel
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.)
N Engl J Med 2009;361:1339-48.
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Details
- Title
- A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes
- Creators
- Mark B. Landon - Ohio State Univ, Dept Obstet & Gynecol, Columbus, OH 43210 USACatherine Y. Spong - Eunice Kennedy Shriver NICHHD, Bethesda, MD USAElizabeth Thom - George Washington UniversityMarshall W. Carpenter - University of Alabama at BirminghamSusan M. Ramin - University of Alabama at BirminghamBrian Casey - Univ Texas SW Med Ctr Dallas, Dallas, TX 75390 USARonald J. Wapner - Columbia UniversityMichael W. Varner - Univ Utah, Salt Lake City, UT USADwight J. Rouse - University of Alabama at BirminghamJohn M. Thorp - University of North Carolina at Chapel HillAnthony Sciscione - Drexel Univ, Philadelphia, PA 19104 USAPatrick Catalano - Case Western Reserve Univ, Cleveland, OH 44106 USAMargaret Harper - Wake Forest Univ Hlth Sci, Winston Salem, NC USAGeorge Saade - Univ Texas Med Branch, Galveston, TX USAKristine Y. Lain - University of PittsburghYoram Sorokin - University of Alabama at BirminghamAlan M. Peaceman - University of Alabama at BirminghamJorge E. Tolosa - Oregon Hlth & Sci Univ, Portland, OR 97201 USAGarland B. Anderson - Univ Texas Med Branch, Galveston, TX USA
- Publication Details
- The New England journal of medicine, v 361(14), pp 1339-1348
- Publisher
- Massachusetts Medical Soc
- Number of pages
- 10
- Grant note
- HD27915; HD34116; HD40485; HD34208; HD27869; HD40500; HD40560; HD34136; HD40544; HD27860; HD40545; HD53097; HD21410; HD27917; HD40512; HD53118; HD36801 / Eunice Kennedy Shriver National Institute of Child Health and Human Development; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) UL1-RR024989; M01-RR00080; UL1-RR025764; C06-RR11234 / National Center for Research Resources; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Research Resources (NCRR) U01HD021410 / EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH &HUMAN DEVELOPMENT; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) M01-RR00034 / General Clinical Research Centers; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Research Resources (NCRR) R24HD050924 / EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) C06RR011234 / NATIONAL CENTER FOR RESEARCH RESOURCES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Research Resources (NCRR)
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- College of Medicine
- Web of Science ID
- WOS:000270300000008
- Scopus ID
- 2-s2.0-70349629019
- Other Identifier
- 991021864117504721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Medicine, General & Internal