Erika F Werner1, Megan E Romano, Dwight J Rouse, Grecio Sandoval, Cynthia Gyamfi-Bannerman, Sean C Blackwell, Alan T N Tita, Uma M Reddy, Lucky Jain, George R Saade, Jay D Iams, Erin A S Clark, John M Thorp, Edward K Chien, Alan M Peaceman, Geeta K Swamy, Mary E Norton, Brian M Casey, Steve N Caritis, Jorge E Tolosa, Yoram Sorokin. 1. Brown University, Providence, Rhode Island; Dartmouth College, Lebanon, New Hampshire; the George Washington University Biostatistics Center, Washington, DC; Columbia University, New York, New York; the University of Texas Health Science Center at Children's Memorial Hermann Hospital, Houston, Texas; the University of Alabama at Birmingham, Birmingham, Alabama; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland; Emory University, Atlanta, Georgia; the University of Texas Medical Branch, Galveston, Texas; The Ohio State University, Columbus, Ohio; the University of Utah Health Sciences Center, Salt Lake City, Utah; the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio; Northwestern University, Chicago, Illinois; Duke University, Durham, North Carolina; Stanford University, Stanford, California; the University of Texas Southwestern Medical Center, Dallas, Texas; University of Pittsburgh, Pittsburgh, Pennsylvania; Oregon Health and Science University, Portland, Oregon; and Wayne State University, Detroit, Michigan.
Abstract
OBJECTIVE: To assess neonatal respiratory morbidity in pregnancies with and without gestational diabetes mellitus (GDM) at imminent risk of late preterm delivery in a modern U.S. cohort. METHODS: Secondary analysis of a randomized placebo-controlled trial in which women with singleton pregnancies at high risk for delivery between 34 0/7 and 36 5/7 weeks of gestation were allocated to betamethasone or placebo. The primary outcome for the trial and this secondary analysis was a composite outcome of neonatal respiratory morbidity in the first 72 hours of life. Secondary outcomes included neonatal severe respiratory complications, neonatal intensive care unit (NICU) admission greater than or equal to 3 days, and hyperbilirubinemia. We examined associations between neonatal morbidities and GDM status after adjustment for baseline differences and study group allocation using modified Poisson regression. Models incorporating a product interaction term between GDM status and treatment arm (betamethasone or placebo) were also evaluated. RESULTS: Of the 2,831 women enrolled in the trial, 306 (10.8%) had GDM. Women with GDM were significantly older and were more likely to be parous and to have hypertensive disorders of pregnancy than those without GDM, but they were similar regarding race, gestational age at randomization (35.6 weeks) and at delivery (36.1 weeks), and study group assignment. Neonates born to women with GDM were no more likely to meet the primary outcome than those born to women without GDM, even after adjusting for differences in age, parity, and hypertensive disorders of pregnancy (12.1% vs 13.1%, adjusted RR 0.84; 95% CI 0.61-1.17), nor were they more likely to have severe respiratory complications or prolonged NICU admission. CONCLUSION: Maternal GDM is not associated with increased neonatal respiratory morbidity in this study population who were at high risk for late preterm birth.
RCT Entities:
OBJECTIVE: To assess neonatal respiratory morbidity in pregnancies with and without gestational diabetes mellitus (GDM) at imminent risk of late preterm delivery in a modern U.S. cohort. METHODS: Secondary analysis of a randomized placebo-controlled trial in which women with singleton pregnancies at high risk for delivery between 34 0/7 and 36 5/7 weeks of gestation were allocated to betamethasone or placebo. The primary outcome for the trial and this secondary analysis was a composite outcome of neonatal respiratory morbidity in the first 72 hours of life. Secondary outcomes included neonatal severe respiratory complications, neonatal intensive care unit (NICU) admission greater than or equal to 3 days, and hyperbilirubinemia. We examined associations between neonatal morbidities and GDM status after adjustment for baseline differences and study group allocation using modified Poisson regression. Models incorporating a product interaction term between GDM status and treatment arm (betamethasone or placebo) were also evaluated. RESULTS: Of the 2,831 women enrolled in the trial, 306 (10.8%) had GDM. Women with GDM were significantly older and were more likely to be parous and to have hypertensive disorders of pregnancy than those without GDM, but they were similar regarding race, gestational age at randomization (35.6 weeks) and at delivery (36.1 weeks), and study group assignment. Neonates born to women with GDM were no more likely to meet the primary outcome than those born to women without GDM, even after adjusting for differences in age, parity, and hypertensive disorders of pregnancy (12.1% vs 13.1%, adjusted RR 0.84; 95% CI 0.61-1.17), nor were they more likely to have severe respiratory complications or prolonged NICU admission. CONCLUSION: Maternal GDM is not associated with increased neonatal respiratory morbidity in this study population who were at high risk for late preterm birth.
Authors: Boyd E Metzger; Lynn P Lowe; Alan R Dyer; Elisabeth R Trimble; Udom Chaovarindr; Donald R Coustan; David R Hadden; David R McCance; Moshe Hod; Harold David McIntyre; Jeremy J N Oats; Bengt Persson; Michael S Rogers; David A Sacks Journal: N Engl J Med Date: 2008-05-08 Impact factor: 91.245
Authors: Mark B Landon; Catherine Y Spong; Elizabeth Thom; Marshall W Carpenter; Susan M Ramin; Brian Casey; Ronald J Wapner; Michael W Varner; Dwight J Rouse; John M Thorp; Anthony Sciscione; Patrick Catalano; Margaret Harper; George Saade; Kristine Y Lain; Yoram Sorokin; Alan M Peaceman; Jorge E Tolosa; Garland B Anderson Journal: N Engl J Med Date: 2009-10-01 Impact factor: 91.245
Authors: Cynthia Gyamfi-Bannerman; Elizabeth A Thom; Sean C Blackwell; Alan T N Tita; Uma M Reddy; George R Saade; Dwight J Rouse; David S McKenna; Erin A S Clark; John M Thorp; Edward K Chien; Alan M Peaceman; Ronald S Gibbs; Geeta K Swamy; Mary E Norton; Brian M Casey; Steve N Caritis; Jorge E Tolosa; Yoram Sorokin; J Peter VanDorsten; Lucky Jain Journal: N Engl J Med Date: 2016-02-04 Impact factor: 91.245
Authors: Ashley N Battarbee; Grecio Sandoval; William A Grobman; Jennifer L Bailit; Uma M Reddy; Ronald J Wapner; Michael W Varner; Steve N Caritis; Mona Prasad; Alan T N Tita; George R Saade; Yoram Sorokin; Dwight J Rouse; Jorge E Tolosa Journal: Am J Perinatol Date: 2020-07-27 Impact factor: 1.862