AzTrials
AzTrials

Cervical RipeningPhase 3OPICNCT04949633

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

A Phase 3 study testing Prostaglandins and Oxytocin in people with Cervical Ripening and Unfavorable Cervix, run by University Hospital, Tours at 14 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Ripening, Unfavorable Cervix
What is being tested?
Prostaglandins and Oxytocin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,494 participants
Where
14 sitesFrance
Study dates
28 Sep 2021to Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Bishop score ≤ 6 at inclusion (unfavorable cervix)
  • French health insurance policy holder
  • Written informed consent

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Caroline DIGUISTO, MD contact

02 47 47 47 39 ext. +33

carolinediguisto@gmail.com

14 sites in 1 country

France14 sites, 10 recruiting

  • Gynaecology-obstetrics, University Hospital, Angers

    Angers, 49033

    Guillaume LEGENDRE, MD-PhD

    Guillaume LEGENDRE, MD-PhD

    Recruiting

  • Gynaecology-obstetrics, University Hospital, Bordeaux

    Bordeaux, 33076

    Terminated

  • Gynaecology-obstetrics, University Hospital, Brest

    Brest, 29609

    Jordan POZZY, MD

    Jordan POZZI, MD

    Recruiting

  • Gynaecology-obstetrics, University Hospital, Clermont-Ferrand

    Clermont-Ferrand, 63001

    Terminated

  • Gynaecology-obstetrics, Hospital St Joseph, Marseille

    Marseille, 13008

    Terminated

  • Gynaecology-obstetrics, University Hospital, Nancy

    Nancy, 54000

    Charline BERTHOLDT, MD

    Charline BERTHOLDT, MD

    Recruiting

  • Gynaecology-obstetrics, University Hospital, Nantes

    Nantes, 44093

    Norbert WINER, MD-PhD

    Norbert WINER, MD-PhD

    Recruiting

  • Gynaecology-obstetrics, University Hospital, Orléans

    Orléans, 45100

    Floranne MEUNIER, MD

    Floranne MEUNIER, MD

    Recruiting

  • Gynaecology-obstetrics, Port Royal Maternity Hospital, Paris

    Paris, 75014

    François GOFFINET, MD

    François GOFFINET, MD

    Recruiting

  • Gynaecology-obstetrics, University Hospital, Poitiers

    Poitiers, 86000

    Terminated

  • Gynaecology-obstetrics, Hospital, Pontoise

    Pontoise, 95300

    Christophe PONCELET, MD-PhD

    Christophe PONCELET, MD-PhD

    Not yet recruiting

  • Gynaecology-obstetrics, University Hospital, Saint Etienne

    Saint-Etienne, 42270

    Tiphaine BARJAT, MD

    Tiphaine BARJAT, MD

    Recruiting

  • Gynaecology-obstetrics, University Hospital, Strasbourg

    Strasbourg, 67000

    Virginie COLLIN-BUND, MD

    Virginie COLLIN-BUND, MD

    Not yet recruiting

  • Gynaecology-obstetrics, University Hospital, Tours

    Tours, 37044

    Franck PERROTIN, MD-PhD

    Franck PERROTIN, MD-PhD

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Prostaglandins, Oxytocin
Keywords
cervical ripening, oxytocin, prostaglandin, cesarean delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProstaglandinsDrug

    Second cervical ripening lasting a maximum of 24 hours

  • OxytocinDrug

    Induction of labor with oxytocin.

Study groups in NCT04949633
Study groupRoleWhat they receive
Induction of laborExperimentalwomen randomized in the experimental group will be admitted to the labor ward to undergo induction of labor with intra-veinous oxytocin and early amniotomy. Oxytocin will be administered according to the French guidelines for induction of labor. Maximum oxytocin used should not exceed 10 UI.
Receives: Drug: Oxytocin
Second cervical ripeningActive comparatorwomen randomized in the control group will undergo a second cervical ripening lasting a maximum of 24 hours with either: * Vaginal slow releasing system of dinoprostone PROPESS® which is inserted in the vagina, against the cervix and left in place during 24 hours. * Oral misoprostol (ANGUSTA®) 25 µg every 2 hours, 8 times (maximum dosage should not exceed 200µg). Tablets will be given one at the time by midwives. * Vaginal gel of dinoprostone (2 mg PROSTINE®) every 6 hours, maximum dose of 6 mg. The choice of the cervical ripening agent will depend of the local protocol of the participating maternity unit. The choice between ANGUSTA®, PROPESS® and PROSTINE® will be made by investigators of each participating unit at the beginning of the trial. At the end of the second cervical ripening procedure women not in labor will be transferred to the labor ward for induction of labor with oxytocin.
Receives: Drug: Prostaglandins; Drug: Oxytocin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cesarean delivery rate

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

    Measured: Up to 2 days after intervention

Secondary outcomes (14)

  1. Time from intervention to delivery in hours

    Measured: Up to 2 days after intervention

  2. The proportion of women who delivered within 12 hours of the intervention

    Measured: Up to 12 hours after intervention

  3. Maternal satisfaction, assessed with the self administered ACE Questionnaire for Assessing Childbirth Experience (QACE)

    Measured: 1 month

  4. The proportion of women who require induction with oxytocin (for women in the control group)

    Measured: Up to 2 days after intervention

  5. The indications of caesarean in case of caesarean delivery

    Measured: Up to 2 days after intervention

  6. The proportion of women with an instrumental delivery

    Measured: Up to 2 days after intervention

  7. The indications for the use of instruments in case of instrumental delivery

    Measured: Up to 2 days after intervention

  8. The proportion of women suspected of per-partum infection

    Measured: Up to 2 days after intervention

  9. The proportion of women with post-partum haemorrhage

    Measured: Up to 1 day after delivery

  10. The proportion of women with severe Post-partum haemorrhage

    Measured: Up to 2 days after intervention

  11. The proportion of women with anal sphincter injury at delivery

    Measured: Up to 2 days after intervention

  12. The proportion of women who need blood transfusion

    Measured: Up to 2 days after intervention

  13. The proportion of women who need for antibiotics

    Measured: Up to 2 days after intervention

  14. The proportion of women admitted to intensive care unit

    Measured: Up to 2 days after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2021
  2. Study start28 Sep 2021
  3. Primary completionSep 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,494 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04949633
Sponsor's protocol ID
DR200090
Other IDs
2021-000989-15
Acronym
OPIC
Status last verified
Jul 2026
First submitted
3 Jun 2021
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data after de-identification can be obtained by contacting the corresponding author

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 randomised non-inferiority trial. BMJ Open. 2023 Apr 17;13(4):e058282. doi: 10.1136/bmjopen-2021-058282.

    PubMed 37068892

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prostaglandins and Oxytocin in people with Cervical Ripening and Unfavorable Cervix, run by University Hospital, Tours at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caroline DIGUISTO, MD (02 47 47 47 39 ext. +33, carolinediguisto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cesarean delivery rate (time frame: Up to 2 days after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04949633, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in