Amanda L Horton1, Yinglei Lai2, Dwight J Rouse3, Catherine Y Spong4, Kenneth J Leveno5, Michael W Varner6, Brian M Mercer7, Jay D Iams8, Ronald J Wapner9, Yoram Sorokin10, John M Thorp11, Susan M Ramin12, Fergal D Malone13, Mary J O'Sullivan14, Gary D V Hankins15, Steve N Caritis16. 1. Department of Obstetrics and Gynecology, NorthShore University Health System, Evanston, Illinois. 2. Department of Obstetrics and Gynecology, George Washington University Biostatistics Center, Washington, District of Columbia. 3. Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama. 4. The Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland. 5. Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas. 6. Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah. 7. Department of Obstetrics and Gynecology, Case Western Reserve University-MetroHealth Medical Center, Cleveland, Ohio. 8. Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio. 9. Department of Obstetrics and Gynecology, Thomas Jefferson University and Drexel University, Philadelphia, Pennsylvania. 10. Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan. 11. Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. 12. Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas. 13. Department of Obstetrics and Gynecology, Columbia University, New York, New York. 14. Department of Obstetrics and Gynecology, University of Miami, Miami, Florida. 15. Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas. 16. Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Abstract
OBJECTIVE: This study aims to evaluate whether magnesium sulfate administration for neuroprotection prolongs latency in women with preterm premature rupture of membranes (PPROM) between 24 and 31(6/7) weeks' gestation. STUDY DESIGN: This is a secondary analysis of a randomized controlled trial of magnesium sulfate for prevention of cerebral palsy. Gravid women with a singleton pregnancy between 24 and 31(6/7) weeks' gestation with PPROM without evidence of labor were randomized to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour up to 12 hours, or placebo. Maternal outcomes for this analysis were delivery in less than 48 hours and in less than 7 days from randomization. Neonatal outcomes included a composite of respiratory distress syndrome, interventricular hemorrhage grades 3 or 4, periventricular leukomalacia, sepsis, necrotizing enterocolitis, retinopathy of prematurity, or death. RESULTS:A total of 1,259 women were included. The rate of delivery < 48 hours was not different in the magnesium sulfate and the placebo groups (22.2 and 20.7%, p = 0.51). Delivery < 7 days was similar between groups (55.4 and 51.4%, p = 0.16). Median latency was also similar between groups (median [interquartile range], 6.0 days [range, 2.4-13.8 days] and 6.6 days [range, 2.4-15.1 days], p = 0.29). Composite neonatal outcomes did not differ between groups. CONCLUSION:Magnesium sulfate administration given for neuroprotection in women with a singleton gestation with PPROM and without labor before 32 weeks does not impact latency. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
RCT Entities:
OBJECTIVE: This study aims to evaluate whether magnesium sulfate administration for neuroprotection prolongs latency in women with preterm premature rupture of membranes (PPROM) between 24 and 31(6/7) weeks' gestation. STUDY DESIGN: This is a secondary analysis of a randomized controlled trial of magnesium sulfate for prevention of cerebral palsy. Gravid women with a singleton pregnancy between 24 and 31(6/7) weeks' gestation with PPROM without evidence of labor were randomized to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour up to 12 hours, or placebo. Maternal outcomes for this analysis were delivery in less than 48 hours and in less than 7 days from randomization. Neonatal outcomes included a composite of respiratory distress syndrome, interventricular hemorrhage grades 3 or 4, periventricular leukomalacia, sepsis, necrotizing enterocolitis, retinopathy of prematurity, or death. RESULTS: A total of 1,259 women were included. The rate of delivery < 48 hours was not different in the magnesium sulfate and the placebo groups (22.2 and 20.7%, p = 0.51). Delivery < 7 days was similar between groups (55.4 and 51.4%, p = 0.16). Median latency was also similar between groups (median [interquartile range], 6.0 days [range, 2.4-13.8 days] and 6.6 days [range, 2.4-15.1 days], p = 0.29). Composite neonatal outcomes did not differ between groups. CONCLUSION:Magnesium sulfate administration given for neuroprotection in women with a singleton gestation with PPROM and without labor before 32 weeks does not impact latency. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
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