Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of C… (NCT04949633) | Clinical Trial Compass
RecruitingPhase 3
Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
France1,494 participantsStarted 2021-09-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant woman
* ≥ 18 years old
* With a singleton cephalic pregnancy
* ≥37+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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.