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Background Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). Methods and findings This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, [greater than or equal to]41+0 and [less than or equal to]42+0 weeks' gestation, a Bishop score Conclusions In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. Trial registration ClinicalTrials.gov NCT02907060., Author(s): Caroline Diguisto 1,2,3,*, Amélie Le Gouge 4, Chloé Arthuis 5, Norbert Winer 5, Olivier Parant 6, Christophe Poncelet 7,8, Celine Chauleur 9,10, Jacob Hannigsberg 11, Guillaume Ducarme 12, Denis [...]