Gestational Diabetes Diagnostic Methods (GD2M) Pilot Randomized Trial
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Gestational Diabetes Diagnostic Methods (GD2M) Pilot Randomized Trial Christina M. Scifres • Kaleab Z. Abebe • Kelley A. Jones • Diane M. Comer • Tina Costacou • Matthew S. Freiberg • Hyagriv N. Simhan • Nancy L. Day • Esa M. Davis
Ó Springer Science+Business Media New York 2014
Abstract To test the feasibility of conducting a pragmatic randomized controlled trial (RCT) comparing the International Association of Diabetes in Pregnancy Study Groups (IADPSG) versus Carpenter–Coustan diagnostic criteria for gestational diabetes (GDM), and to examine patient and provider views on GDM screening. A singleblinded pragmatic pilot RCT. Participants with a singleton pregnancy between 24 and 28 weeks gestation received a 50 g oral glucose challenge test and if the value was \200 mg/dL were randomized to either the 2 h 75 g OGTT using the IADPSG criteria or the 3 h 100 g OGTT using the Carpenter–Coustan criteria. Primary outcome was the feasibility of randomization and screening. Secondary outcomes included patient and provider views (or preferences) on GDM testing. Sixty-eight women were recruited, 48 (71 %) enrolled and 47 (69 %) were randomized. Participants in both study arms identified the main challenges to GDM testing to be: drinking the glucola, fasting prior to testing, waiting to have blood drawn, and multiple venipuntures. Women in both study arms would prefer the 2 h 75 g OGTT or whichever test is recommended by their doctor in a future pregnancy. Physicians and nurse midwives endorsed screening and were C. M. Scifres (&) H. N. Simhan Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, 300 Halket Street, Pittsburgh, PA 15213, USA e-mail: [email protected] K. Z. Abebe D. M. Comer M. S. Freiberg E. M. Davis Department of Medicine, University of Pittsburgh, 300 Halket Street, Pittsburgh, PA 15213, USA K. A. Jones T. Costacou N. L. Day Graduate School of Public Health, University of Pittsburgh, 300 Halket Street, Pittsburgh, PA 15213, USA
comfortable with being blinded to the GDM testing strategy and results values. Both pregnant women and providers value GDM screening, and pregnant women can be recruited to a blinded, randomized GDM screening trial with minimal attrition and missing data. Keywords Gestational diabetes Pregnancy Screening Randomized clinical trial
Introduction Gestational diabetes (GDM) increases risk for obstetrical complications including the birth of a large-for-gestational age (LGA) infant, pre-eclampsia, cesarean delivery, and neonatal morbidity [1–3]. GDM is commonly diagnosed in the United States using a 1-h screening test with a 50-g glucose load followed by a 3-h 100-g glucose tolerance test for those found to have abnormal screening [3]. The approach identifies approximately 5–6 % of the population as having GDM [3]. However, glucose levels lower than those traditionally used for the diagnosis of GDM may also be associated with increased risk for maternal and neonatal morbidity [4]. Based on this knowledge, The International
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