OBJECTIVE: We sought to determine whether prophylactic treatment with 17-alpha-hydroxyprogesterone caproate (17Pc) in twin pregnancy will reduce neonatal morbidity (primary outcome) by prolonging pregnancy (secondary outcome). STUDY DESIGN: This was a double-blind, randomized clinical trial. Mothers carrying dichorionic-diamniotic twins were randomly assigned (in a 2:1 ratio) to weekly injections of 250 mg of 17Pc or placebo, starting at 16-24 weeks and continued until 34 weeks. RESULTS: In all, 160 women were randomized to 17Pc and 80 toplacebo. Composite neonatal morbidity occurred with similar frequency in the 17Pc and placebo groups (14% vs 12%, respectively, P = .62). Mean gestational age at delivery was not affected by 17Pc (35.3 vs 35.9 weeks, P = .10), but a 3-day difference in median gestational age favored placebo (P = .02). There were no perinatal deaths with 17Pc and 3 with placebo. CONCLUSION: In twin pregnancy, prophylactic treatment with 17Pc did not prolong gestation or reduce neonatal morbidity.
RCT Entities:
OBJECTIVE: We sought to determine whether prophylactic treatment with 17-alpha-hydroxyprogesterone caproate (17Pc) in twin pregnancy will reduce neonatal morbidity (primary outcome) by prolonging pregnancy (secondary outcome). STUDY DESIGN: This was a double-blind, randomized clinical trial. Mothers carrying dichorionic-diamniotic twins were randomly assigned (in a 2:1 ratio) to weekly injections of 250 mg of 17Pc or placebo, starting at 16-24 weeks and continued until 34 weeks. RESULTS: In all, 160 women were randomized to 17Pc and 80 to placebo. Composite neonatal morbidity occurred with similar frequency in the 17Pc and placebo groups (14% vs 12%, respectively, P = .62). Mean gestational age at delivery was not affected by 17Pc (35.3 vs 35.9 weeks, P = .10), but a 3-day difference in median gestational age favored placebo (P = .02). There were no perinatal deaths with 17Pc and 3 with placebo. CONCLUSION: In twin pregnancy, prophylactic treatment with 17Pc did not prolong gestation or reduce neonatal morbidity.
Authors: Roberto Romero; Kypros Nicolaides; Agustin Conde-Agudelo; Ann Tabor; John M O'Brien; Elcin Cetingoz; Eduardo Da Fonseca; George W Creasy; Katharina Klein; Line Rode; Priya Soma-Pillay; Shalini Fusey; Cetin Cam; Zarko Alfirevic; Sonia S Hassan Journal: Am J Obstet Gynecol Date: 2011-12-11 Impact factor: 8.661
Authors: William A Grobman; Elizabeth A Thom; Catherine Y Spong; Jay D Iams; George R Saade; Brian M Mercer; Alan T N Tita; Dwight J Rouse; Yoram Sorokin; Ronald J Wapner; Kenneth J Leveno; Sean Blackwell; M Sean Esplin; Jorge E Tolosa; John M Thorp; Steve N Caritis; J Peter Van Dorsten Journal: Am J Obstet Gynecol Date: 2012-09-17 Impact factor: 8.661
Authors: G R Saade; E A Thom; W A Grobman; J D Iams; B M Mercer; U M Reddy; A T N Tita; D J Rouse; Y Sorokin; R J Wapner; K J Leveno; S C Blackwell; M S Esplin; J E Tolosa; J M Thorp; S N Caritis; J P Vandorsten Journal: Ultrasound Obstet Gynecol Date: 2018-10-26 Impact factor: 7.299