Recruiting NCT04949633

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

Phase III Interventional Cervical Ripening Unfavorable Cervix

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Prostaglandins, Oxytocin.
Who it may be relevant to: Registry conditions: Cervical Ripening, Unfavorable Cervix. Basic parameters: from 18 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Oxytocine Versus Prostaglandines Pour le déclenchement du Travail Des Femmes Dont le Col Est défavorable après 24 Heures de Maturation Cervicale : Essai Multicentrique randomisé de Non infériorité

Overview

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.

Detailed description

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.

Interventions

Drug Prostaglandins
Second cervical ripening lasting a maximum of 24 hours
Drug Oxytocin
Induction of labor with oxytocin.

Primary outcome measures

Cesarean delivery rate [Time frame: Up to 2 days after intervention]

Secondary outcome measures (12)

Time from intervention to delivery in hours [Time frame: Up to 2 days after intervention]
The proportion of women who delivered within 12 hours of the intervention [Time frame: Up to 12 hours after intervention]
Maternal satisfaction, assessed with the self administered ACE Questionnaire for Assessing Childbirth Experience (QACE) [Time frame: 1 month]
The proportion of women who require induction with oxytocin (for women in the control group) [Time frame: Up to 2 days after intervention]
The indications of caesarean in case of caesarean delivery [Time frame: Up to 2 days after intervention]
The proportion of women with an instrumental delivery [Time frame: Up to 2 days after intervention]
The indications for the use of instruments in case of instrumental delivery [Time frame: Up to 2 days after intervention]
The proportion of women suspected of per-partum infection [Time frame: Up to 2 days after intervention]
The proportion of women with post-partum haemorrhage [Time frame: Up to 1 day after delivery]
The proportion of women with severe Post-partum haemorrhage [Time frame: Up to 2 days after intervention]
The proportion of women with anal sphincter injury at delivery [Time frame: Up to 2 days after intervention]
The proportion of women who need blood transfusion [Time frame: Up to 2 days after intervention]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

France · 14 centers

Gynaecology-obstetrics, University Hospital, Angers — Angers
Gynaecology-obstetrics, University Hospital, Bordeaux — Bordeaux
Gynaecology-obstetrics, University Hospital, Brest — Brest
Gynaecology-obstetrics, University Hospital, Clermont-Ferrand — Clermont-Ferrand
Gynaecology-obstetrics, Hospital St Joseph, Marseille — Marseille
Gynaecology-obstetrics, University Hospital, Nancy — Nancy
Gynaecology-obstetrics, University Hospital, Nantes — Nantes
Gynaecology-obstetrics, University Hospital, Orléans — Orléans
… and 6 more centers

Publications

De Berti M, Le Gouge A, Monmousseau F, Gallot D, Sentilhes L, Winer N, Legendre G, Desbriere R, Girault A, Pozzi J, Gachon B, Barjat T, Perrotin F, Brunet-Houdard S, Diguisto C; Groupe de Recherche en Gynecologie Obstetrique. Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC): protocol for an open multicentre randomis PMID 37068892

Identifiers

NCT: NCT04949633 · DR200090 · 2021-000989-15

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗