RUBAPRO: Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT03310333

Collaborator

(none)

Enrollment

Location

Arms

28.5

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PROM (Premature Rupture Of Foetal Membrane)	Drug: Propess® (dinoprostone) Device: cook cervical pipening balloon	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

open

Primary Purpose:

Treatment

Official Title:

Comparison Between Two Strategies of Induction in Case of Unfavourable Cervix After 12 Hours of Premature Rupture of Membranes (PROM) at Term: Cook Cervical Ripening + Oxytocine From 6 Hours Versus Dinoprostone Vaginal Insert

Actual Study Start Date :

Feb 14, 2018

Anticipated Primary Completion Date :

Apr 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 • 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.
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) 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.

Arm

Intervention/Treatment

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

• 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.

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)

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.

Outcome Measures

Primary Outcome Measures

Time between the beginning of the induction of labor and the delivery [at day 1]

Secondary Outcome Measures

Time limits between the PROM and the beginning of induction [at day 1]
Rate of delivery in the first 24 hours [at day 1]
Application time of Cook® balloon [at day 1]
Application time of Propess® [at day 1]
Time between labour induction and vaginal delivery [at day 1]
Rate of vaginal delivery with and without extraction [at day 1]
Rate of cesarean [at day 1]
Rate of delivery hemorrhage [at day 1]
Bischop score when Cook balloon is fallen or retry [at day 1]
Rate of balloon present after 12 hours [at day 1]
Rate of anomaly of fetal heart rate leading stop of dinoprostone [at day 1]
Rate of epidural analgesia [at day 1]
Time to obtain active labour [at day 1]
Time to obtain complete cervix dilatation [at day 1]
Rate of fever during the labour [at day 1]
Rate of uterine hyperkinesias [at day 1]
Rate of clinic chorio-amnionitis defined by Newton criteria [at day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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