OBJECTIVE: Our purpose was to examine the maternal and fetal outcomes of the 180 women with insulin-dependent diabetes mellitus who became pregnant during the Diabetes Control and Complications Trial. STUDY DESIGN: The Diabetes Control and Complications Trial was a multicenter controlled clinical trial that compared intensive with conventional therapy in insulin-dependent diabetes mellitus. Intensive therapy, with the aim of achieving normal glycemic control, was initiated in women originally assigned to conventional therapy who actively sought to become pregnant or who became pregnant. RESULTS: A total of 180 women completed 270 pregnancies between 1983 and 1993, with 191 total live births. The mean glycosylated hemoglobin level was significantly different between the treatment groups at conception (7.4% +/- 1.3% in intensive vs. 8.1% +/- 1.7% in conventional therapy, p = 0.0001) but was similar during gestation (6.6% +/- 0.8% and 6.6% +/- 1.3%). Nine congenital malformations were identified (4.7%), eight of which occurred in women originally assigned to conventional therapy (p = 0.06). There were 32 spontaneous abortions, 13.3% in the intensive and 10.4% in the women originally assigned to conventional treatment (not significant). There were no significant differences in outcome between the women with conventional treatment who initiated intensive therapy preconception and those who began it after conception. CONCLUSIONS: Timely institution of intensive therapy is associated with rates of spontaneous abortion and congenital malformation similar to those in the nondiabetic population.
RCT Entities:
OBJECTIVE: Our purpose was to examine the maternal and fetal outcomes of the 180 women with insulin-dependent diabetes mellitus who became pregnant during the Diabetes Control and Complications Trial. STUDY DESIGN: The Diabetes Control and Complications Trial was a multicenter controlled clinical trial that compared intensive with conventional therapy in insulin-dependent diabetes mellitus. Intensive therapy, with the aim of achieving normal glycemic control, was initiated in women originally assigned to conventional therapy who actively sought to become pregnant or who became pregnant. RESULTS: A total of 180 women completed 270 pregnancies between 1983 and 1993, with 191 total live births. The mean glycosylated hemoglobin level was significantly different between the treatment groups at conception (7.4% +/- 1.3% in intensive vs. 8.1% +/- 1.7% in conventional therapy, p = 0.0001) but was similar during gestation (6.6% +/- 0.8% and 6.6% +/- 1.3%). Nine congenital malformations were identified (4.7%), eight of which occurred in women originally assigned to conventional therapy (p = 0.06). There were 32 spontaneous abortions, 13.3% in the intensive and 10.4% in the women originally assigned to conventional treatment (not significant). There were no significant differences in outcome between the women with conventional treatment who initiated intensive therapy preconception and those who began it after conception. CONCLUSIONS: Timely institution of intensive therapy is associated with rates of spontaneous abortion and congenital malformation similar to those in the nondiabetic population.
Authors: John L Kitzmiller; Jennifer M Block; Florence M Brown; Patrick M Catalano; Deborah L Conway; Donald R Coustan; Erica P Gunderson; William H Herman; Lisa D Hoffman; Maribeth Inturrisi; Lois B Jovanovic; Siri I Kjos; Robert H Knopp; Martin N Montoro; Edward S Ogata; Pathmaja Paramsothy; Diane M Reader; Barak M Rosenn; Alyce M Thomas; M Sue Kirkman Journal: Diabetes Care Date: 2008-05 Impact factor: 19.112