Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04949633 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: OPIC
StatusRecruiting
PhasePhase 3
Started2021-09-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
See other at-risk trials from University Hospital, Tours

Amendment history

2026-07-23
critical
Study Status, Contacts/Locations v6
Primary completion pushed: 2026-09 → 2027-09
Completion pushed: 2026-11 → 2027-11
Study sites12→14
2025-11-27
minor
Study Status, Eligibility, Contacts/Locations v5
Primary completion date2025-09→2026-09
Completion date2025-11→2026-11
Study sites10→12
Eligibility criteria-71 characters
Inclusion Criteria: Pregnant woman ≥ 18 years old With a singleton cephalic pregnancy Between ≥37+0 weeks and ≤ 42+0 weeks of gestation Gestational age estimated from the fir [...] agent) Contra-indications for using oxytocin Woman in labor or with more than 3 contractions / 10 minutes
2022-11-09
minor
Study Status, Contacts/Locations, IPDSharing v4
Study sitesdetails revised at 9 of 10 sites
2022-03-08
minor
Study Status v3
Re-verified, no change to tracked fields
2021-10-08
minor
Study Status, Outcome Measures v2
Secondary endpointsdetails revised at 13 of 14 entries
2021-09-29
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-09→2025-09
Completion date2024-09→2025-11
Start dateestimated 2021-09→confirmed 2021-09-28
Study sitesdetails revised at 10 of 10 sites
2021-06-25
minor
Original filing
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.
Trial Details
NCT Number NCT04949633
Lead Sponsor University Hospital, Tours
Conditions Cervical Ripening, Unfavorable Cervix
Enrollment 1,494 participants
Start Date 2021-09-28
Primary Completion 2027-09 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-27