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Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial.
Verspyck, Eric; de Vienne, Claire; Muszynski, Charles; Bubenheim, Michael; Chanavaz-Lacheray, Isabella; Dreyfus, Michel; Deruelle, Philippe; Benichou, Jacques.
Afiliação
  • Verspyck E; Department of Obstetrics and Gynecology, Rouen University Hospital, Rouen, France.
  • de Vienne C; Department of Obstetrics and Gynecology, Caen University Hospital, Caen, France.
  • Muszynski C; Department of Obstetrics and Gynecology, Amiens University Hospital, Amiens, France.
  • Bubenheim M; Department of Biostatistics, Rouen University Hospital, Rouen, France.
  • Chanavaz-Lacheray I; Department of Obstetrics and Gynecology, Belvedere Hospital, Mont-Saint-Aignan, France.
  • Dreyfus M; Department of Obstetrics and Gynecology, Caen University Hospital, Caen, France.
  • Deruelle P; Department of Obstetrics and Gynecology, Lille University, EA 4489-Environnement Périnatal et Santé, Lille, France.
  • Benichou J; Inserm U657, University of Rouen and Biostatistics, Rouen, France.
PLoS One ; 12(3): e0173717, 2017.
Article em En | MEDLINE | ID: mdl-28333939
OBJECTIVE: To assess the impact of maintenance nifedipine therapy on pregnancy duration in women with preterm placenta previa bleeding. METHODS: PPADAL was a randomized, double-blind, placebo-controlled trial conducted between 05/2008 and 05/2012 in five French hospitals. The trial included 109 women, aged ≥ 18 years, with at least one episode of placenta previa bleeding, intact membranes and no other pregnancy complication, at gestational age 24 to 34 weeks and after 48 hours of complete acute tocolysis. Women were randomly allocated to receive either 20 mg of slow-release nifedipine three times daily (n = 54) or placebo (n = 55) until 36 + 6 weeks of gestation. The primary outcome for the trial was length of pregnancy measured in days after enrolment. Main secondary outcomes were rates of recurrent bleeding, cesarean delivery due to hemorrhage, blood transfusion, maternal side effects, gestational age at delivery and adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage > grade 2, perventricular leukomalacia > grade 1, or necrotizing enterocolitis). Analysis was by intention to treat. RESULTS: Mean (SD) prolongation of pregnancy was not different between the nifedipine (n = 54) and the placebo (n = 55) group; 42.5 days ± 23.8 versus 44.2 days ± 24.5, p = 0.70. Cesarean due to hemorrhage performed before 37 weeks occurred more frequently in the nifedipine group in comparison with the placebo group (RR, 1.66; 95% confidence interval, 1.05-2.72). Adverse perinatal outcomes were comparable between groups; 3.8% for nifedipine versus 5.5% for placebo (relative risk, 0.52; 95% confidence interval 0.10-2.61). No maternal mortality or perinatal death occurred. CONCLUSION: Maintenance oral nifedipine neither prolongs duration of pregnancy nor improves maternal or perinatal outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT00620724.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Placenta Prévia / Nifedipino / Tocolíticos Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies Limite: Adult / Female / Humans / Pregnancy Idioma: En Ano de publicação: 2017 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Placenta Prévia / Nifedipino / Tocolíticos Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies Limite: Adult / Female / Humans / Pregnancy Idioma: En Ano de publicação: 2017 Tipo de documento: Article