Induction of labor at term with vaginal misoprostol or a prostaglandin E2 pessary: a noninferiority randomized controlled trial

Cost‐effectiveness analysis of vaginal misoprostol versus dinoprostone pessary: A non‐inferiority large randomized controlled trial in France

“…Our primary analysis with the cesarean delivery rate was based on a non‐significant clinical difference between treatment arms. Associated clinical work demonstrated no non‐inferiority of misoprostol but according to a limited difference in cesarean delivery rate, both drugs remain considered 13 . We believe that this similar efficacy in terms of cesarean delivery rate underlines the need for additional economic data.…”

“…The CYTOPRO trial was an open‐label, multicenter, randomized, non‐inferiority trial conducted from September 2012 to June 2015 in four French centers and aimed to compare the efficacy and safety of intravaginal misoprostol (25 μg) every 4 h with the efficacy and safety of a 10‐mg slow‐release dinoprostone pessary (PGE2) 13 . Participating centers were public centers, with two in the Paris area (Bicêtre and Poissy), one in Strasbourg, and one in Toulouse; all belong to the French Obstetrics and Gynecology Research Group.…”

“…Following the analyses in the associated clinical paper, we focused on the per-protocol population. 13 Economic data for the mother or the infant were not available for five patients and were imputed by a single imputation method. Descriptive analyses of costs were performed on the incomplete dataset according to the treatment used, with mean and bias-corrected and accelerated 95% bootstrapped confidence intervals.…”

“…Therefore, we adhered to their primary analysis. 13 Second, the major protocol deviations for excluded women led to additional missing economic data directly associated with these deviations.…”

“…In cases of non-reassuring fetal heart rate or uterine tachysystole, the pessary was removed and replaced after normalization of electronic fetal monitoring if removed within the first 12 h. Women in both groups were monitored identically, with a 1-hour fetal heart rate analysis every 4 h. 13…”