Randomization of Early Diabetes Screening Among Obese Pregnant Women (REDSOAP Study)


      ACOG recommends early diabetes screening in all obese pregnant women. Many MFM specialists screen obese patients early in pregnancy for diabetes with the assumption of improving perinatal outcomes. However, Harper et al, in their published study in 2020 did not find significant difference in composite perinatal outcome in early diabetes screening compared with standard screening in the late second trimester. This study aimed to investigate whether early diabetes screening before 20 weeks in obese women is beneficial compared to traditional screening at 24 to 28 weeks.

      Study Design

      This prospective randomized trial was conducted at the University of Illinois at Chicago from 2017-2019 and involved 600 patients. Of these, 296 patients were randomized in the early screening group whereby 1-hour GCT and HbA1C were performed before 20 weeks of gestation followed by a 3-hour OGTT if 1-hour GCT > 140 mg/dL. In the standard screening group, 304 patients were randomized into HbA1C only before 20 weeks but had 1-hour GCT between 24 and 28 weeks using the same two-step approach. The Carpenter and Coustan criteria were used for the diagnosis of gestational diabetes. The primary outcome was macrosomia, birth weight > 4000 g, and secondary outcome was composite perinatal outcome.


      Baseline characteristic, medical complication and behavioral risk factors at recruitment were similar in both groups, except there were more African American women in the standard group (P = 0.08), and Hispanics in the early screening group (P < 0.01) (table 1). The gestational age at delivery, birth weight and composite perinatal outcomes; macrosomia, shoulder dystocia, primary cesarean delivery, and development of preeclampsia were similar. Early screening group had more gestational diabetics and usage of insulin than the standard group (table 2).


      In this intention to treat analysis, we showed no benefit in early screening for diabetes in obese women comparing to traditional screening regarding development of macrosomia, and composite perinatal outcomes.
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