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Status unknownNCT03310333RUBAPROUpdated Feb 19, 2018

Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes

A Phase 4 interventional study of Propess® (dinoprostone) and cook cervical pipening balloon in PROM (Premature Rupture Of Foetal Membrane), sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by University Hospital, Clermont-Ferrand · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.

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Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The objective is to demonstrate the superiority of the strategy of labor induction by Cook® cervical ripening balloon between recommended strategy by dinoprostone (propess®) on the reduction of the time between cervical ripening and delivery in case of unfavorable cervix after 12 hours of PROM in term pregnant women.

Read the detailed description

The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning.

If the cervix is unfavourable (cervical Bishop's score \<6), the information of the study is given to the patient and the consent collected.

An antibiotic is started at the beginning of the inclusion by amoxicillin (or clindamycin in case of allergy of amoxicillin) to prevent choroamnionitis.

After randomization, the patient is included in one of the two groups: Cook ® balloon or Propess ®.

  • In the Cook cervical ripening balloon group: the device is introduced by a resident or a doctor. No traction on the probe was done. It is left in place for maximum 12 hours. Oxytocin is added at the end of the first 6 hours even if device is fallen. An epidural analgesia can be started before or after the installation of oxytocin
  • In dinoprostone vaginal group: the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable.

After 24 hours, it is removed. If they are any contraction, oxytocin is started with or without epidural analgesic.

  • The fetal heart rate is monitoring 30 minutes before and after the insertion of the device. After, the patient has a monitoring each 6 hours.
  • Since the oxytocin is started, the monitoring is registered in continue until the delivery.
02

Conditions studied

  • PROM (Premature Rupture Of Foetal Membrane)

Keywords

  • PROM
  • Dinoprostone
  • cervical ripening device
  • oxytocin
03

In context

Fetal Membranes, Premature Rupture

100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.

This study's planned enrollment of 80 is below the median of 150 across 59 interventional studies indexed under Fetal Membranes, Premature Rupture.

Browse Fetal Membranes, Premature Rupture studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Browse University Hospital, Clermont-Ferrand studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women

    • 18 years old With a singleton live cephalic pregnancy ≥ 37+0 weeks Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation) PROM without spontaneous labour in the 12 hours after the rupture. The diagnostic of PROM is clinic or biologic (ActimProm® test).

Unfavourable cervix (Bishop's score \< 6) Agreement of the patient after clear, loyal and appropriate information Subject covered by or having the rights to the French Social Security system

Exclusion criteria

Exclusion Criteria:

  • Vaginal infection by B streptococcus or in urinary sample during actual or anterior pregnancy Meconium fluid amniotic of vaginal delivery (placenta praevia, ...) Temperature > 38,2°C Suspicion of chorio-amnionitis among Newton requirements Intra-uterine growth restriction \< 3rd percentile with Doppler abnormalities History of cesarean and uterine scare Suspected genital herpes infection Known VIH seropositivity (confirmed by blood serology) Fetus with suspected severe congenital abnormalities Pathological fetal heart rate (see appendix 1) Contra-indications to Propess®, Cook® Cervical Ripening Balloon, Oxytocin Women under guardianship or trusteeship
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Cook cervical ripening

    the device is introduced by a resident or a doctor. No traction on the probe was done. It is left in place for maximum 12 hours. Oxytocin is added at the end of the first 6 hours even if device is fallen. An epidural analgesia can be started before or after the installation of oxytocin

    Device: cook cervical pipening balloon

  • Active comparator
    Dinoprostone vaginal group

    the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable. After 24 hours, it is removed. If they are any contraction, oxytocin is started with or without epidural analgesic.

    Drug: Propess® (dinoprostone)

Interventions

  • DrugPropess® (dinoprostone)

    The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning. If the cervix is unfavourable (cervical Bishop's score \<6), the information of the study is given to the patient and the consent collected. An antibiotic is started at the beginning of the inclusion by amoxicillin (or clindamycin in case of allergy of amoxicillin) to prevent choroamnionitis.

  • Devicecook cervical pipening balloon

    • In dinoprostone vaginal group: the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable.

06

What researchers measure

Primary outcomes

  1. Time between the beginning of the induction of labor and the delivery

    Time frame: at day 1

Secondary outcomes

  1. Time limits between the PROM and the beginning of induction

    Time frame: at day 1

  2. Rate of delivery in the first 24 hours

    Time frame: at day 1

  3. Application time of Cook® balloon

    Time frame: at day 1

  4. Application time of Propess®

    Time frame: at day 1

  5. Time between labour induction and vaginal delivery

    Time frame: at day 1

  6. Rate of vaginal delivery with and without extraction

    Time frame: at day 1

  7. Rate of cesarean

    Time frame: at day 1

  8. Rate of delivery hemorrhage

    Time frame: at day 1

  9. Bischop score when Cook balloon is fallen or retry

    Time frame: at day 1

  10. Rate of balloon present after 12 hours

    Time frame: at day 1

  11. Rate of anomaly of fetal heart rate leading stop of dinoprostone

    Time frame: at day 1

  12. Rate of epidural analgesia

    Time frame: at day 1

  13. Time to obtain active labour

    Time frame: at day 1

  14. Time to obtain complete cervix dilatation

    Time frame: at day 1

  15. Rate of fever during the labour

    Time frame: at day 1

  16. Rate of uterine hyperkinesias

    Time frame: at day 1

  17. Rate of clinic chorio-amnionitis defined by Newton criteria

    Time frame: at day 1

07

Study locations

1 of 1 sites recruiting
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
    Recruiting
08

References and documents

Publications

  • Devillard E, Delabaere A, Rouzaire M, Pereira B, Accoceberry M, Houlle C, Dejou-Bouillet L, Bouchet P, Gallot D. Induction of labour in case of premature rupture of membranes at term with an unfavourable cervix: protocol for a randomised controlled trial comparing double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO) treatments. BMJ Open. 2019 Jun 20;9(6):e026090. doi: 10.1136/bmjopen-2018-026090. PubMed 31227530 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2018 (actual). Primary completion is estimated for Apr 2020, 25 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2017
First posted
Oct 16, 2017
StartActual
Feb 14, 2018
Primary completionEst.
Apr 1, 2020
CompletionEst.
Jul 1, 2020
Last update
Feb 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03310333
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
Feb 14, 2018
Primary completion
Apr 1, 2020 (estimated)
Completion
Jul 1, 2020 (estimated)
Last update
Feb 19, 2018

Study contacts

Patrick LACARIN
Contact
placarin@chu-clermontferrand.fr
04 73 75 11 95
Denis GALLOT
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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