Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
Condition(s) studied
Investigational drug(s) / intervention(s)
Prostaglandins: Second cervical ripening lasting a maximum of 24 hours
Oxytocin: Induction of labor with oxytocin.
Study 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.
Eligibility
Primary outcome measure(s)
- Cesarean delivery rate — Up to 2 days after intervention
The main outcome is the rate of caesarean delivery, whatever the indication of the caesarean delivery
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Gynaecology-obstetrics, University Hospital, Angers | Angers | France | Recruiting |
| Gynaecology-obstetrics, University Hospital, Bordeaux | Bordeaux | France | Terminated |
| Gynaecology-obstetrics, University Hospital, Brest | Brest | France | Recruiting |
| Gynaecology-obstetrics, University Hospital, Clermont-Ferrand | Clermont-Ferrand | France | Terminated |
| Gynaecology-obstetrics, Hospital St Joseph, Marseille | Marseille | France | Terminated |
| Gynaecology-obstetrics, University Hospital, Nancy | Nancy | France | Recruiting |
| Gynaecology-obstetrics, University Hospital, Nantes | Nantes | France | Recruiting |
| Gynaecology-obstetrics, University Hospital, Orléans | Orléans | France | Recruiting |
| Gynaecology-obstetrics, Port Royal Maternity Hospital, Paris | Paris | France | Recruiting |
| Gynaecology-obstetrics, University Hospital, Poitiers | Poitiers | France | Terminated |
| Gynaecology-obstetrics, Hospital, Pontoise | Pontoise | France | Not Yet Recruiting |
| Gynaecology-obstetrics, University Hospital, Saint Etienne | Saint-Etienne | France | Recruiting |
| Gynaecology-obstetrics, University Hospital, Strasbourg | Strasbourg | France | Not Yet Recruiting |
| Gynaecology-obstetrics, University Hospital, Tours | Tours | France | Recruiting |
More University Hospital, Tours trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04949633 on ClinicalTrials.gov ↗ ← All trials in France