• B Martinez de Tejada, A Karolinski, M C Ocampo, C Laterra, I Hösli, D Fernández, D Surbek, M Huespe, G Drack, A Bunader, S Rouillier, G López de Degani, E Seidenstein, E Prentl, J Antón, F Krähenmann, D Nowacki, M Poncelas, J C Nassif, R Papera, C Tuma, R Espoile, O Tiberio, G Breccia, A Messina, B Peker, E Schinner, B W Mol, L Kanterewicz, V Wainer, M Boulvain, V Othenin-Girard, M V Bertolino, O Irion, and 4P trial group.
• Department of Obstetrics and Gynaecology, Faculty of Medicine, Geneva University Hospitals and University of Geneva, Geneva, Switzerland.
• BJOG. 2015 Jan 1; 122 (1): 80-91.

ObjectiveTo evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour.DesignMulticentre, randomised, double-blind, placebo-controlled trial.SettingTwenty-nine centres in Switzerland and Argentina.PopulationA total of 385 women with preterm labour (24(0/7) to 33(6/7) weeks of gestation) treated with acute tocolysis.MethodsParticipants were randomly allocated to either 200 mg daily of self-administered vaginal progesterone or placebo within 48 hours of starting acute tocolysis.Main Outcome MeasuresPrimary outcome was delivery before 37 weeks of gestation. Secondary outcomes were delivery before 32 and 34 weeks, adverse effects, duration of tocolysis, re-admissions for preterm labour, length of hospital stay, and neonatal morbidity and mortality. The study was ended prematurely based on results of the intermediate analysis.ResultsPreterm birth occurred in 42.5% of women in the progesterone group versus 35.5% in the placebo group (relative risk [RR] 1.2; 95% confidence interval [95% CI] 0.93-1.5). Delivery at <32 and <34 weeks did not differ between the two groups (12.9 versus 9.7%; [RR 1.3; 95% CI 0.7-2.5] and 19.7 versus 12.9% [RR 1.5; 95% CI 0.9-2.4], respectively). The duration of tocolysis, hospitalisation, and recurrence of preterm labour were comparable between groups. Neonatal morbidity occurred in 44 (22.8%) cases on progesterone versus 35 (18.8%) cases on placebo (RR: 1.2; 95% CI 0.82-1.8), whereas there were 4 (2%) neonatal deaths in each study group.ConclusionThere is no evidence that the daily administration of 200 mg vaginal progesterone decreases preterm birth or improves neonatal outcome in women with preterm labour.© 2014 Royal College of Obstetricians and Gynaecologists.

42 keywords...

hide…