A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes

A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes

2009 October 1; | Mark B. Landon, M.D., Catherine Y. Spong, M.D., Elizabeth Thom, Ph.D., Marshall W. Carpenter, M.D., Susan M. Ramin, M.D., Brian Casey, M.D., Ronald J. Wapner, M.D., Michael W. Varner, M.D., Dwight J. Rouse, M.D., John M. Thorp Jr., M.D., Anthony Sciscione, D.O., Patrick Catalano, M.D., Margaret Harper, M.D., George Saade, M.D., Kristine Y. Lain, M.D., Yoram Sorokin, M.D., Alan M. Peaceman, M.D., Jorge E. Tolosa, M.D., M.S.C.E., and Garland B. Anderson, M.D.
This multicenter, randomized trial aimed to evaluate the effectiveness of treating mild gestational diabetes mellitus (GDM) in improving pregnancy outcomes. Women with mild GDM (fasting glucose <95 mg/dL and abnormal oral glucose-tolerance test results) were randomly assigned to either usual prenatal care (control group) or a treatment group receiving dietary intervention, self-monitoring of blood glucose, and insulin therapy if necessary. The primary outcome was a composite of stillbirth or perinatal death and neonatal complications. A total of 958 women were enrolled, with 485 in the treatment group and 473 in the control group. There was no significant difference in the frequency of the composite primary outcome between the groups (32.4% vs. 37.0%, P = 0.14). However, treatment was associated with significant reductions in several secondary outcomes, including mean birth weight, neonatal fat mass, large-for-gestational-age infants, birth weight >4000 g, shoulder dystocia, and cesarean delivery. Treatment also reduced the rates of preeclampsia and gestational hypertension (8.6% vs. 13.6%, P = 0.01). The study concluded that while treatment did not significantly reduce the frequency of the composite primary outcome, it reduced risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and hypertensive disorders.This multicenter, randomized trial aimed to evaluate the effectiveness of treating mild gestational diabetes mellitus (GDM) in improving pregnancy outcomes. Women with mild GDM (fasting glucose <95 mg/dL and abnormal oral glucose-tolerance test results) were randomly assigned to either usual prenatal care (control group) or a treatment group receiving dietary intervention, self-monitoring of blood glucose, and insulin therapy if necessary. The primary outcome was a composite of stillbirth or perinatal death and neonatal complications. A total of 958 women were enrolled, with 485 in the treatment group and 473 in the control group. There was no significant difference in the frequency of the composite primary outcome between the groups (32.4% vs. 37.0%, P = 0.14). However, treatment was associated with significant reductions in several secondary outcomes, including mean birth weight, neonatal fat mass, large-for-gestational-age infants, birth weight >4000 g, shoulder dystocia, and cesarean delivery. Treatment also reduced the rates of preeclampsia and gestational hypertension (8.6% vs. 13.6%, P = 0.01). The study concluded that while treatment did not significantly reduce the frequency of the composite primary outcome, it reduced risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and hypertensive disorders.
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Understanding A multicenter%2C randomized trial of treatment for mild gestational diabetes.