Current partner codePEPTIDESDE
NCT04949633·Phase 3·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 3

Enrollment

1,494

Locations

14

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full detailed description

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. In some units, women are admitted into labor ward for induction of labor with oxytocin. Elsewhere cervical ripening is repeated in order to obtain a favorable cervix and to reduce the risk of caesarean delivery. 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

Treatment arms and agents.

DRUG

Prostaglandins

Second cervical ripening lasting a maximum of 24 hours

DRUG

Oxytocin

Induction of labor with oxytocin.

Timeline

From registration to results.

  1. First posted

    Jul 2, 2021

  2. Study start

    Sep 28, 2021

  3. Primary completion

    Sep 2027

  4. Study completion

    Nov 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 27, 2026

Outcomes

What the study measures.

Primary outcomes

Cesarean delivery rate

Time frame · Up to 2 days after intervention

The main outcome is the rate of caesarean delivery, whatever the indication of the caesarean delivery

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
Yes

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

Study locations

14 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

Gynaecology-obstetrics, University Hospital, Angers

Angers, France

Gynaecology-obstetrics, University Hospital, Bordeaux

Bordeaux, France

Gynaecology-obstetrics, University Hospital, Brest

Brest, France

Gynaecology-obstetrics, University Hospital, Clermont-Ferrand

Clermont-Ferrand, France

Gynaecology-obstetrics, Hospital St Joseph, Marseille

Marseille, France

Gynaecology-obstetrics, University Hospital, Nancy

Nancy, France

Gynaecology-obstetrics, University Hospital, Nantes

Nantes, France

Gynaecology-obstetrics, University Hospital, Orléans

Orléans, France

Gynaecology-obstetrics, Port Royal Maternity Hospital, Paris

Paris, France

Gynaecology-obstetrics, University Hospital, Poitiers

Poitiers, France

Gynaecology-obstetrics, Hospital, Pontoise

Pontoise, France

Gynaecology-obstetrics, University Hospital, Saint Etienne

Saint-Etienne, France

Gynaecology-obstetrics, University Hospital, Strasbourg

Strasbourg, France

Gynaecology-obstetrics, University Hospital, Tours

Tours, France

Related trials

More studies on Oxytocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.