About this trial
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.
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 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant woman
≥ 18 years old
With a singleton cephalic pregnancy
≥37+0 weeks of gestation
Disqualifiers
Any measures of legal protection
Prior caesarean section or uterine scar
Contra-indications to a vaginal delivery
Foetus with suspected severe congenital abnormalities
Trial design
Parallel
Treatments tested in this trial
Prostaglandins
DrugSecond cervical ripening lasting a maximum of 24 hours
Oxytocin
DrugInduction of labor with oxytocin.
Treatment groups
Trial outcomes
Primary outcomes
Cesarean delivery rate
The main outcome is the rate of caesarean delivery, whatever the indication of the caesarean delivery
Secondary outcomes
Time from intervention to delivery in hours
The proportion of women who delivered within 12 hours of the intervention
Maternal satisfaction, assessed with the self administered ACE Questionnaire for Assessing Childbirth Experience (QACE)
The proportion of women who require induction with oxytocin (for women in the control group)
Other outcomes
Number and rate of children with an Apgar score under 7
Number and rate of children with neonatal acidosis defined as umbilical arterial pH <7,00
Number and rate of children with early neonatal infection
Number and rate of children admitted in an intensive care unit
Sponsors and contacts
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