Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening

Twenty-two percent of deliveries in France are induced. In cases where labor is induced and cervix is unfavorable, cervical ripening prior oxytocin administration is advised in order to reduce the risk of cesarean delivery. Cervical ripening agents, pharmacological (prostaglandins) or mechanical are administered during 24 hours. After 24 hours, most women will be either delivered or in labor but 25% of women will require further induction of labor. For 16% of women who undergo cervical ripening, whatever the cervical ripening method, the cervix remains unchanged after 24 hours. The management of these women is not consensual and depends on the maternity unit where women are cared for. In some units, women are admitted into labor ward for induction of labor with oxytocin. Elsewhere cervical ripening is repeated in order to obtain a favorable cervix and to reduce the risk of caesarean delivery.

This study seeks to identify the most appropriate strategy for the management of women with an unfavorable cervix after 24 hours of cervical ripening, a strategy which would be associated with the lowest maternal and perinatal morbidity but also with the best maternal satisfaction. Because both strategies are practiced in France, the trial would compare: induction of labor with oxytocin and repeated cervical ripening. The policy of induction of labor with oxytocin, being the simpler strategy, would be acceptable if it did not lead to a substantially proportion of women with caesarean deliveries compared with a second cervical ripening. This multicenter non inferiority randomized trial will recruit women with an unfavorable cervix (bishop score ≤ 6) after 24 hours of cervical ripening (pharmacological or mechanical) and randomize them to either induction of labor with oxytocin or to a second cervical ripening with prostaglandins. The aim is to show that repeating cervical ripening is an unnecessary procedure. And more specifically that oxytocin administration is not associated with a higher caesarean delivery rate and that it reduces the time to delivery in comparison with cervical ripening with prostaglandins.

• Time from intervention to delivery in hours [Срок оценки: Up to 2 days after intervention]
• The proportion of women who delivered within 12 hours of the intervention [Срок оценки: Up to 12 hours after intervention]
• Maternal satisfaction, assessed with the self administered ACE Questionnaire for Assessing Childbirth Experience (QACE) [Срок оценки: 1 month]
• The proportion of women who require induction with oxytocin (for women in the control group) [Срок оценки: Up to 2 days after intervention]
• The indications of caesarean in case of caesarean delivery [Срок оценки: Up to 2 days after intervention]
• The proportion of women with an instrumental delivery [Срок оценки: Up to 2 days after intervention]
• The indications for the use of instruments in case of instrumental delivery [Срок оценки: Up to 2 days after intervention]
• The proportion of women suspected of per-partum infection [Срок оценки: Up to 2 days after intervention]
• The proportion of women with post-partum haemorrhage [Срок оценки: Up to 1 day after delivery]
• The proportion of women with severe Post-partum haemorrhage [Срок оценки: Up to 2 days after intervention]
• The proportion of women with anal sphincter injury at delivery [Срок оценки: Up to 2 days after intervention]
• The proportion of women who need blood transfusion [Срок оценки: Up to 2 days after intervention]