Maria L Brizot1, Wagner Hernandez2, Adolfo W Liao2, Roberto E Bittar2, Rossana P V Francisco2, Vera L J Krebs3, Marcelo Zugaib2. 1. Department of Obstetrics and Gynecology, São Paulo University Medical School, São Paulo, Brazil. Electronic address: mlbrizot@uol.com.br. 2. Department of Obstetrics and Gynecology, São Paulo University Medical School, São Paulo, Brazil. 3. Department of Pediatrics, São Paulo University Medical School, São Paulo, Brazil.
Abstract
OBJECTIVE: The purpose of this study was to investigate the use of vaginal progesterone for the prevention of preterm delivery in twin pregnancies. STUDY DESIGN: We conducted a prospective, randomized, double-blind, placebo-controlled trial that involved 390 naturally conceived twin pregnancies among mothers with no history of preterm delivery who were receiving antenatal care at a single center. Women with twin pregnancies between 18 and 21 weeks and 6 days' gestation were assigned randomly to daily vaginal progesterone (200 mg) or placebo ovules until 34 weeks and 6 days' gestation. The primary outcome was the difference in mean gestational age at delivery; the secondary outcomes were the rate of spontaneous delivery at <34 weeks' gestation and the rate of neonatal composite morbidity and mortality in the treatment and nontreatment groups. RESULTS: The baseline characteristics were similar in both groups. The final analysis included 189 women in the progesterone group and 191 in the placebo group. No difference (P = .095) in the mean gestational age at delivery was observed between progesterone (35.08 ± 3.19 [SD]) and placebo groups (35.55 ± 2.85). The incidence of spontaneous delivery at <34 weeks' gestation was 18.5% in the progesterone group and 14.6% in the placebo group (odds ratio, 1.32; 95% confidence interval, 0.24-2.37). No difference in the composite neonatal morbidity and mortality was observed between the progesterone (15.5%) and placebo (15.9%) groups (odds ratio, 1.01; 95% confidence interval, 0.58-1.75). CONCLUSION: In nonselected twin pregnancies, vaginal progesterone administration does not prevent preterm delivery and does not reduce neonatal morbidity and death.
RCT Entities:
OBJECTIVE: The purpose of this study was to investigate the use of vaginal progesterone for the prevention of preterm delivery in twin pregnancies. STUDY DESIGN: We conducted a prospective, randomized, double-blind, placebo-controlled trial that involved 390 naturally conceived twin pregnancies among mothers with no history of preterm delivery who were receiving antenatal care at a single center. Women with twin pregnancies between 18 and 21 weeks and 6 days' gestation were assigned randomly to daily vaginal progesterone (200 mg) or placebo ovules until 34 weeks and 6 days' gestation. The primary outcome was the difference in mean gestational age at delivery; the secondary outcomes were the rate of spontaneous delivery at <34 weeks' gestation and the rate of neonatal composite morbidity and mortality in the treatment and nontreatment groups. RESULTS: The baseline characteristics were similar in both groups. The final analysis included 189 women in the progesterone group and 191 in the placebo group. No difference (P = .095) in the mean gestational age at delivery was observed between progesterone (35.08 ± 3.19 [SD]) and placebo groups (35.55 ± 2.85). The incidence of spontaneous delivery at <34 weeks' gestation was 18.5% in the progesterone group and 14.6% in the placebo group (odds ratio, 1.32; 95% confidence interval, 0.24-2.37). No difference in the composite neonatal morbidity and mortality was observed between the progesterone (15.5%) and placebo (15.9%) groups (odds ratio, 1.01; 95% confidence interval, 0.58-1.75). CONCLUSION: In nonselected twin pregnancies, vaginal progesterone administration does not prevent preterm delivery and does not reduce neonatal morbidity and death.
Authors: C A Combs; E Schuit; S N Caritis; A C Lim; T J Garite; K Maurel; D Rouse; E Thom; A T Tita; Bwj Mol Journal: BJOG Date: 2015-12-10 Impact factor: 6.531
Authors: R Romero; A Conde-Agudelo; A Rehal; E Da Fonseca; M L Brizot; L Rode; V Serra; E Cetingoz; A Syngelaki; A Tabor; A Perales; S S Hassan; K H Nicolaides Journal: Ultrasound Obstet Gynecol Date: 2022-02 Impact factor: 8.678
Authors: R Romero; A Conde-Agudelo; W El-Refaie; L Rode; M L Brizot; E Cetingoz; V Serra; E Da Fonseca; M S Abdelhafez; A Tabor; A Perales; S S Hassan; K H Nicolaides Journal: Ultrasound Obstet Gynecol Date: 2017-03 Impact factor: 7.299