Anna Palatnik1, Lisa Mele2, Mark B Landon3, Uma M Reddy4, Susan M Ramin5, Marshall W Carpenter6, Ronald J Wapner7, Michael W Varner8, Dwight J Rouse9, John M Thorp10, Anthony Sciscione11, Patrick Catalano12, George R Saade13, Steve N Caritis14, Yoram Sorokin15. 1. Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL. Electronic address: anna.palatnik@northwestern.edu. 2. George Washington University Biostatistics Center, Washington, DC. 3. Department of Obstetrics and Gynecology, The Ohio State University, Columbus, OH. 4. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD. 5. Department of Obstetrics and Gynecology, The University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, TX. 6. Department of Obstetrics and Gynecology, Alpert Medical School, Brown University, Providence, RI. 7. Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY. 8. Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, UT. 9. Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL. 10. Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC. 11. Department of Obstetrics and Gynecology, Drexel University School of Medicine, Philadelphia, PA. 12. Department of Obstetrics and Gynecology, Case Western Reserve University-MetroHealth Medical Center, Cleveland, OH. 13. Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX. 14. Department of Obstetrics and Gynecology, University of Pittsburgh School of Medicine, Pittsburgh, PA. 15. Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI.
Abstract
OBJECTIVE: The purpose of this study was to examine the association between gestational age (GA) at the time of treatment initiation for gestational diabetes mellitus (GDM) and maternal and perinatal outcomes. STUDY DESIGN: We conducted a secondary analysis of a multicenter randomized treatment trial of mild GDM in which women with mild GDM were assigned randomly to treatment vs usual care. The primary outcome of the original trial, as well as this analysis, was a composite perinatal adverse outcome that included neonatal hypoglycemia, hyperbilirubinemia, hyperinsulinemia, and perinatal death. Other outcomes that were examined included the frequency of large for GA, birthweight, neonatal intensive care unit admission, gestational hypertension/preeclampsia, and cesarean delivery. The interaction between GA at treatment initiation (stratified as 24-26, 27, 28, 29, and ≥30 weeks of gestation) and treatment group (treated vs routine care), with the outcomes of interest, was used to determine whether GA at treatment initiation was associated with outcome differences. RESULTS: Of 958 women whose cases were analyzed, those who initiated treatment at an earlier GA did not gain an additional treatment benefit compared with those who initiated treatment at a later GA (probability value for interaction with the primary outcome, .44). Similarly, there was no evidence that other outcomes were improved significantly by earlier initiation of GDM treatment (large for GA, P = .76; neonatal intensive care unit admission, P = .8; cesarean delivery, P = .82). The only outcome that had a significant interaction between GA and treatment was gestational hypertension/preeclampsia (P = .04), although there was not a clear cut GA trend where this outcome improved with treatment. CONCLUSION: Earlier initiation of treatment of mild GDM was not associated with stronger effect of treatment on perinatal outcomes.
RCT Entities:
OBJECTIVE: The purpose of this study was to examine the association between gestational age (GA) at the time of treatment initiation for gestational diabetes mellitus (GDM) and maternal and perinatal outcomes. STUDY DESIGN: We conducted a secondary analysis of a multicenter randomized treatment trial of mild GDM in which women with mild GDM were assigned randomly to treatment vs usual care. The primary outcome of the original trial, as well as this analysis, was a composite perinatal adverse outcome that included neonatal hypoglycemia, hyperbilirubinemia, hyperinsulinemia, and perinatal death. Other outcomes that were examined included the frequency of large for GA, birthweight, neonatal intensive care unit admission, gestational hypertension/preeclampsia, and cesarean delivery. The interaction between GA at treatment initiation (stratified as 24-26, 27, 28, 29, and ≥30 weeks of gestation) and treatment group (treated vs routine care), with the outcomes of interest, was used to determine whether GA at treatment initiation was associated with outcome differences. RESULTS: Of 958 women whose cases were analyzed, those who initiated treatment at an earlier GA did not gain an additional treatment benefit compared with those who initiated treatment at a later GA (probability value for interaction with the primary outcome, .44). Similarly, there was no evidence that other outcomes were improved significantly by earlier initiation of GDM treatment (large for GA, P = .76; neonatal intensive care unit admission, P = .8; cesarean delivery, P = .82). The only outcome that had a significant interaction between GA and treatment was gestational hypertension/preeclampsia (P = .04), although there was not a clear cut GA trend where this outcome improved with treatment. CONCLUSION: Earlier initiation of treatment of mild GDM was not associated with stronger effect of treatment on perinatal outcomes.
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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: Julie Brown; Nisreen A Alwan; Jane West; Stephen Brown; Christopher Jd McKinlay; Diane Farrar; Caroline A Crowther Journal: Cochrane Database Syst Rev Date: 2017-05-04