William A Grobman1, Madeline M Rice1, Uma M Reddy1, Alan T N Tita1, Robert M Silver1, Gail Mallett1, Kim Hill1, Elizabeth A Thom1, Yasser Y El-Sayed1, Annette Perez-Delboy1, Dwight J Rouse1, George R Saade1, Kim A Boggess1, Suneet P Chauhan1, Jay D Iams1, Edward K Chien1, Brian M Casey1, Ronald S Gibbs1, Sindhu K Srinivas1, Geeta K Swamy1, Hyagriv N Simhan1, George A Macones1. 1. From the Department of Obstetrics and Gynecology, Northwestern University, Chicago (W.A.G., G.M.); University of Alabama at Birmingham, Birmingham (A.T.N.T.); University of Utah Health Sciences Center, Salt Lake City (R.M.S., K.H.); Stanford University, Stanford, CA (Y.Y.E.-S.); Columbia University, New York (A.P.-D.); Brown University, Providence, RI (D.J.R.); University of Texas Medical Branch, Galveston (G.R.S.), University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and University of Texas Southwestern Medical Center, Dallas (B.M.C.) - all in Texas; University of North Carolina at Chapel Hill, Chapel Hill (K.A.B.), and Duke University, Durham (G.K.S.) - both in North Carolina; Ohio State University, Columbus (J.D.I.), and MetroHealth Medical Center, Case Western Reserve University, Cleveland (E.K.C.) - both in Ohio; University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); University of Pennsylvania, Philadelphia (S.K.S.); University of Pittsburgh, Pittsburgh (H.N.S.) - both in Pennsylvania; Washington University, St. Louis (G.A.M.); the George Washington University Biostatistics Center, Washington, DC (M.M.R., E.A.T.); and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.).
Abstract
BACKGROUND: The perinatal and maternal consequences of induction of labor at 39 weeks among low-risk nulliparous women are uncertain. METHODS: In this multicenter trial, we randomly assigned low-risk nulliparous women who were at 38 weeks 0 days to 38 weeks 6 days ofgestation to labor induction at 39 weeks 0 days to 39 weeks 4 days or to expectant management. The primary outcome was a composite of perinatal death or severe neonatal complications; the principal secondary outcome was cesarean delivery. RESULTS: A total of 3062 women were assigned to labor induction, and 3044 were assigned to expectant management. The primary outcome occurred in 4.3% of neonates in the induction group and in 5.4% in the expectant-management group (relative risk, 0.80; 95% confidence interval [CI], 0.64 to 1.00). The frequency of cesarean delivery was significantly lower in the induction group than in the expectant-management group (18.6% vs. 22.2%; relative risk, 0.84; 95% CI, 0.76 to 0.93). CONCLUSIONS: Induction of labor at 39 weeks in low-risk nulliparous women did not result in a significantly lower frequency of a composite adverse perinatal outcome, but it did result in a significantly lower frequency of cesarean delivery. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ARRIVE ClinicalTrials.gov number, NCT01990612 .).
RCT Entities:
BACKGROUND: The perinatal and maternal consequences of induction of labor at 39 weeks among low-risk nulliparous women are uncertain. METHODS: In this multicenter trial, we randomly assigned low-risk nulliparous women who were at 38 weeks 0 days to 38 weeks 6 days of gestation to labor induction at 39 weeks 0 days to 39 weeks 4 days or to expectant management. The primary outcome was a composite of perinatal death or severe neonatal complications; the principal secondary outcome was cesarean delivery. RESULTS: A total of 3062 women were assigned to labor induction, and 3044 were assigned to expectant management. The primary outcome occurred in 4.3% of neonates in the induction group and in 5.4% in the expectant-management group (relative risk, 0.80; 95% confidence interval [CI], 0.64 to 1.00). The frequency of cesarean delivery was significantly lower in the induction group than in the expectant-management group (18.6% vs. 22.2%; relative risk, 0.84; 95% CI, 0.76 to 0.93). CONCLUSIONS: Induction of labor at 39 weeks in low-risk nulliparous women did not result in a significantly lower frequency of a composite adverse perinatal outcome, but it did result in a significantly lower frequency of cesarean delivery. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ARRIVE ClinicalTrials.gov number, NCT01990612 .).
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