A multicenter, randomized trial of treatment for mild gestational diabetes

Mark B. Landon, Catherine Y. Spong, Elizabeth Thom, Marshall W. Carpenter, Susan M. Ramin, Brian Casey, Ronald J. Wapner, Michael W. Varner, Dwight J. Rouse, John M. Thorp, Anthony Sciscione, Patrick Catalano, Margaret Harper, George Saade, Kristine Y. Lain, Yoram Sorokin, Alan M. Peaceman, Jorge E. Tolosa, Garland B. Anderson

Research output: Contribution to journalArticle

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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.)

Original languageEnglish (US)
Pages (from-to)1339-1348
Number of pages10
JournalNew England Journal of Medicine
Volume361
Issue number14
DOIs
StatePublished - Oct 1 2009

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Gestational Diabetes
Multicenter Studies
Dystocia
Stillbirth
Therapeutics
Birth Weight
Control Groups
Blood Glucose Self-Monitoring
Pregnancy Induced Hypertension
Hyperbilirubinemia
Prenatal Care
Hyperinsulinism
Pregnancy Outcome
Glucose Tolerance Test
Pre-Eclampsia
Hypoglycemia
Gestational Age
Fasting
Fats
Parturition

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Landon, M. B., Spong, C. Y., Thom, E., Carpenter, M. W., Ramin, S. M., Casey, B., ... Anderson, G. B. (2009). A multicenter, randomized trial of treatment for mild gestational diabetes. New England Journal of Medicine, 361(14), 1339-1348. https://doi.org/10.1056/NEJMoa0902430

A multicenter, randomized trial of treatment for mild gestational diabetes. / Landon, Mark B.; Spong, Catherine Y.; Thom, Elizabeth; Carpenter, Marshall W.; Ramin, Susan M.; Casey, Brian; Wapner, Ronald J.; Varner, Michael W.; Rouse, Dwight J.; Thorp, John M.; Sciscione, Anthony; Catalano, Patrick; Harper, Margaret; Saade, George; Lain, Kristine Y.; Sorokin, Yoram; Peaceman, Alan M.; Tolosa, Jorge E.; Anderson, Garland B.

In: New England Journal of Medicine, Vol. 361, No. 14, 01.10.2009, p. 1339-1348.

Research output: Contribution to journalArticle

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 2009, 'A multicenter, randomized trial of treatment for mild gestational diabetes', New England Journal of Medicine, vol. 361, no. 14, pp. 1339-1348. https://doi.org/10.1056/NEJMoa0902430
Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B et al. A multicenter, randomized trial of treatment for mild gestational diabetes. New England Journal of Medicine. 2009 Oct 1;361(14):1339-1348. https://doi.org/10.1056/NEJMoa0902430
Landon, Mark B. ; Spong, Catherine Y. ; Thom, Elizabeth ; Carpenter, Marshall W. ; Ramin, Susan M. ; Casey, Brian ; Wapner, Ronald J. ; Varner, Michael W. ; Rouse, Dwight J. ; Thorp, John M. ; Sciscione, Anthony ; Catalano, Patrick ; Harper, Margaret ; Saade, George ; Lain, Kristine Y. ; Sorokin, Yoram ; Peaceman, Alan M. ; Tolosa, Jorge E. ; Anderson, Garland B. / A multicenter, randomized trial of treatment for mild gestational diabetes. In: New England Journal of Medicine. 2009 ; Vol. 361, No. 14. pp. 1339-1348.
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AU - Landon, Mark B.

AU - Spong, Catherine Y.

AU - Thom, Elizabeth

AU - Carpenter, Marshall W.

AU - Ramin, Susan M.

AU - Casey, Brian

AU - Wapner, Ronald J.

AU - Varner, Michael W.

AU - Rouse, Dwight J.

AU - Thorp, John M.

AU - Sciscione, Anthony

AU - Catalano, Patrick

AU - Harper, Margaret

AU - Saade, George

AU - Lain, Kristine Y.

AU - Sorokin, Yoram

AU - Peaceman, Alan M.

AU - Tolosa, Jorge E.

AU - Anderson, Garland B.

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N2 - 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.)

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