Lorie M Harper1, Lisa Mele, Mark B Landon, Marshall W Carpenter, Susan M Ramin, Uma M Reddy, Brian Casey, Ronald J Wapner, Michael W Varner, John M Thorp, Anthony Sciscione, Patrick Catalano, Margaret Harper, George Saade, Steve N Caritis, Yoram Sorokin, Alan M Peaceman, Jorge E Tolosa. 1. Departments of Obstetrics and Gynecology, the University of Alabama at Birmingham, Birmingham, Alabama, The Ohio State University, Columbus, Ohio, Brown University, Providence, Rhode Island, the University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, the University of Texas Southwestern Medical Center, Dallas, Texas, Columbia University, New York, New York, the University of Utah, Salt Lake City, Utah, the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, Drexel University, Philadelphia, Pennsylvania, Case Western Reserve University-MetroHealth Medical Center, Cleveland, Ohio, Wake Forest University Health Sciences, Winston-Salem, North Carolina, the University of Texas Medical Branch, Galveston, Texas; the University of Pittsburgh, Pittsburgh, Pennsylvania; Wayne State University, Detroit, Michigan, Northwestern University, Chicago, Illinois, and Oregon Health & Science University, Portland, Oregon; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Abstract
OBJECTIVE: Use of Carpenter-Coustan compared with National Diabetes Data Group criteria increases the number of women diagnosed with gestational diabetes mellitus (GDM) by 30-50%, but whether treatment of this milder GDM reduces adverse outcomes is unknown. We explored the effects of the diagnostic criteria used on the benefits of GDM treatment. METHODS: This was a secondary analysis of a randomized trial for treatment of mild GDM diagnosed using Carpenter-Coustan criteria. We evaluated the effect of treatment within two mutually exclusive diagnostic groups: 1) women who met the stricter National Diabetes Data Group as well asCarpenter-Coustan criteria (National Diabetes Data Group), and 2) those diagnosed by Carpenter-Coustan but not meeting National Diabetes Data Group criteria (Carpenter-Coustan only). Maternal outcomes examined were pregnancy-induced hypertension, shoulder dystocia, maternal weight gain, and cesarean delivery. Neonatal outcomes were large for gestational age, macrosomia (greater than 4,000 g), fat mass, small for gestational age, and a composite outcome of perinatal death, birth injury, hypoglycemia, hyperbilirubinemia, and hyperinsulinemia. Analysis of variance or the Breslow-Day test, as appropriate, was used to test for the interaction between diagnostic criteria and GDM treatment on the outcomes of interest. RESULTS:Of 958 patients, 560 (58.5%) metNational Diabetes Data Group criteria and 398 (41.5%) met Carpenter-Coustan only. Compared with untreated women, the direction of treatment effect did not differ by diagnostic criteria used and was consistent with the original trial. The P value for interaction between diagnostic criteria and treatment status was not significant for any outcome. CONCLUSION: The overall beneficial treatment effect on pregnancy-induced hypertension, shoulder dystocia, cesarean delivery, and macrosomia was seen in patients diagnosed by the higher National Diabetes Data Group and by the lower thresholds of the Carpenter-Coustan criteria.
RCT Entities:
OBJECTIVE: Use of Carpenter-Coustan compared with National Diabetes Data Group criteria increases the number of women diagnosed with gestational diabetes mellitus (GDM) by 30-50%, but whether treatment of this milder GDM reduces adverse outcomes is unknown. We explored the effects of the diagnostic criteria used on the benefits of GDM treatment. METHODS: This was a secondary analysis of a randomized trial for treatment of mild GDM diagnosed using Carpenter-Coustan criteria. We evaluated the effect of treatment within two mutually exclusive diagnostic groups: 1) women who met the stricter National Diabetes Data Group as well as Carpenter-Coustan criteria (National Diabetes Data Group), and 2) those diagnosed by Carpenter-Coustan but not meeting National Diabetes Data Group criteria (Carpenter-Coustan only). Maternal outcomes examined were pregnancy-induced hypertension, shoulder dystocia, maternal weight gain, and cesarean delivery. Neonatal outcomes were large for gestational age, macrosomia (greater than 4,000 g), fat mass, small for gestational age, and a composite outcome of perinatal death, birth injury, hypoglycemia, hyperbilirubinemia, and hyperinsulinemia. Analysis of variance or the Breslow-Day test, as appropriate, was used to test for the interaction between diagnostic criteria and GDM treatment on the outcomes of interest. RESULTS: Of 958 patients, 560 (58.5%) met National Diabetes Data Group criteria and 398 (41.5%) met Carpenter-Coustan only. Compared with untreated women, the direction of treatment effect did not differ by diagnostic criteria used and was consistent with the original trial. The P value for interaction between diagnostic criteria and treatment status was not significant for any outcome. CONCLUSION: The overall beneficial treatment effect on pregnancy-induced hypertension, shoulder dystocia, cesarean delivery, and macrosomia was seen in patients diagnosed by the higher National Diabetes Data Group and by the lower thresholds of the Carpenter-Coustan criteria.
Authors: Risa M Hoffman; Caitlin Newhouse; Brian Chu; Jeffrey S A Stringer; Judith S Currier Journal: Curr HIV/AIDS Rep Date: 2021-01-05 Impact factor: 5.071
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