Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes

NCT ID: NCT03310333

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2020-07-01

Brief 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.

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.

Conditions

PROM (Premature Rupture Of Foetal Membrane)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

cook cervical pipening balloon

Intervention Type: DEVICE

• 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.

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.

Group Type: ACTIVE_COMPARATOR

Propess® (dinoprostone)

Intervention Type: DRUG

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.

Interventions

Propess® (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.

Intervention Type: DRUG

cook 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Vaginal infection by B streptococcus or in urinary sample during actual or anterior pregnancy Meconium fluid amniotic Contraindication 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis GALLOT

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Patrick LACARIN

Role: CONTACT

placarin@chu-clermontferrand.fr

04 73 75 11 95

Facility Contacts

Patrick LACARIN

Role: primary

placarin@chu-clermontferrand.fr

04 73 75 11 95

References

de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

Reference Type: DERIVED

PMID: 36996264 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31227530 (View on PubMed)

Other Identifiers

2017-A00811-52

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-352

Identifier Type: -

Identifier Source: org_study_id