Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
Recruiting
Phase 3
Interventional Study
Cervical Ripening
Unfavorable Cervix
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,494 (estimated)
- Sponsor
- University Hospital, Tours · Other
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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 2…
Trial Locations
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Eligibility Criteria
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 pharmacolog…
Contacts