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

  • STATUS
    Recruiting
  • End date
    Nov 24, 2025
  • participants needed
    1494
  • sponsor
    University Hospital, Tours
Updated on 24 October 2021
Accepts healthy volunteers

Summary

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.

Description

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.

Details
Condition Cervical Ripening, Labor/Delivery, Unfavorable Cervix, Labor
Treatment Oxytocin, Prostaglandins
Clinical Study IdentifierNCT04949633
SponsorUniversity Hospital, Tours
Last Modified on24 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pregnant woman
years old
With a singleton cephalic pregnancy
Between 37+0 weeks and 42+0 weeks of gestation
Gestational age estimated from the first trimester ultrasound (realized between 11+0 and 13+6 weeks of gestation)
With a medical indication of labor with a previous pharmacological or mechanical cervical ripening of 24 hours
Bishop score 6 at inclusion (unfavorable cervix)
French health insurance policy holder
Written informed consent

Exclusion Criteria

Any measures of legal protection
Prior caesarean section or uterine scar
Contra-indications to a vaginal delivery
Foetus with suspected severe congenital abnormalities
Pathological foetal heart rate
Contra-indications to ANGUSTA (oral misoprostol, cervical ripening agent)
Contra-indications to PROPESS (vaginal slow releasing system of dinoprostone, cervical ripening agent)
Contra-indications to PROSTINE (vaginal gel of dinoprostone, cervical ripening agent)
Contra-indications for using oxytocin
Woman in labor or with more than 3 contractions / 10 minutes
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