Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of PROM (RUBAPRO2)

NCT05568745 | Recruiting Phase 4 DMC

• 3 other identifiers: PHRC N 2020 GALLOT2022-A01479-342022-501142-30-00
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 5

Brief Summary

Premature rupture of membranes (PROM) at term complicates 6 to 22% of singleton pregnancies. Spontaneous labour occurs in 60-67% of these patients within 24h. If no effective uterine contraction occurs, induction of labour (IOL) is the strategy recommended by the French as well as the American College of Obstetricians and Gynecologists. The optimal strategy for IOL in case of PROM with an unfavourable cervix remains unknown and none of the studies conducted in nulliparous women showed the superiority of one induction method over another. In the current project, we aimed to determine (1) if IOL with association of balloon catheter and oxytocin after 6 hours could increase the rate of delivery \< 24h versus low dose of oral misoprostol (25 µg oral PGE1 every 2h) in case of PROM at term in nulliparous women and (2) patient satisfaction using EXIT survey assessed before hospital discharge.

Conditions

Induction of Labor; Cervical Ripening; Premature Rupture of Fetal Membranes; Nulliparous

Keywords

premature rupture of membranes; labour induction; unfavourable cervix; cervical ripening balloon; pharmacological cervical ripening; misoprostol

Outcome Measures

Primary Outcomes (2)

• Vaginal delivery <24hours

  Proportion of patients vaginally delivered \<24hours (in %)

  at birth

• Patient satisfaction

  Satisfaction of women concerning method of induction by the EXperience of Induction Tool (EXIT) validated in french language.

  up to 4 days

Secondary Outcomes (19)

• Duration from rupture to beginning of induction

  at birth

• Duration between IOL and delivery

  at birth

• Duration of balloon exposure or misoprostol exposure

  at birth

• Misoprostol received

  at birth

• Bishop score on balloon removal

  at birth

Study Arms (2)

Balloon+oxytocin

EXPERIMENTAL

Mecanical cervical ripening will be done by transcervical balloon (Teleflex French Dufour catheter CH20 reference 174000). Oxytocin will be started 6 hours after balloon insertion. At H12 balloon will be removed and induction continued by oxytocin alone.

Device: Balloon for cervical ripening (Teleflex French Dufour catheter CH20 reference 174000); Drug: Oxytocin

Oral misoprostol

ACTIVE COMPARATOR

Patients will receive misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations. (Oxytocin can be started at least 4 hours after the last misoprostol administration if patient remains not in labour.)

Drug: Misoprostol Oral Tablet

Interventions

Balloon for cervical ripening (Teleflex French Dufour catheter CH20 reference 174000) DEVICE

Balloon catheter is inserted by a resident or a physician under visual control. The expected volume injected in the balloon probe is 60 mL. No traction is performed on the catheter. The catheter is left in place for a maximum of 12 hours.

Balloon+oxytocin

Oxytocin DRUG

Intravenous oxytocin addition (preceded or followed by epidural analgesia on patient's request) will be performed 6 hours after insertion of balloon catheter. Oxytocin is administered as an intravenous infusion (5 IU of oxytocin in 49 mL of 5% glucose\*) at the lowest possible dose with the aim of achieving a maximum of three to four contractions per ten minutes. After appropriate uterine activity has been achieved, the rate of the oxytocin infusion is decreased or stopped.

Balloon+oxytocin

Misoprostol Oral Tablet DRUG

Patients will receive misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations.

Oral misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old,
• Pregnant, Gestational age ≥ 37 weeks
• Singleton pregnancy with cephalic presentation
• Nulliparous
• PROM without labour beyond 12 hours
• Unfavourable cervix (Bischop score \< 6)
• Able to give her informed consent
• Ability to comply with the requirement of the study
• Covered by the French Social Security welfare system

You may not qualify if:

• Unable to understand French language
• Contraindication for vaginal delivery
• Loss of meconium amniotic fluid (LA)
• Temperature \> 38.2°C
• Intrauterine infection
• IUGR with Doppler anomaly
• Fetus with expected polymalformative syndrome
• Scarred womb
• Suspicion of genital herpes
• Known HIV seropositivity
• Placenta praevia
• Fetal death
• Abnormal FHR (Fetal Heart Rate)
• Contraindication to misoprostol:
• Allergy or hypersensibility

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (5)

CHU de Bordeaux

Bordeaux, 33000, France

NOT YET RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Assistance Publique Hôpitaux de Paris- CHU Bicêtre

Le Kremlin-Bicêtre, 94275, France

NOT YET RECRUITING

CHU de Saint Etienne

Saint-Etienne, 42270, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, 31059, France

NOT YET RECRUITING

Related Publications (1)

• Rouzaire M, Triolaire A, Vayssiere C, Sentilhes L, Barjat T, Luton D; Groupe de Recherche en Obstetrique et Gynecologie (GROG) Investigators; Davoust E, Cabrespine A, Pereira B, Gallot D. Balloon plus oxytocin or oral misoprostol for labour induction in prelabour rupture of membranes (PROM): protocol for a randomised controlled trial (RUBAPRO2). BMJ Open. 2026 Jan 27;16(1):e110425. doi: 10.1136/bmjopen-2025-110425.

  PMID: 41592839 DERIVED

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Oxytocin; Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Denis Gallot

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is impossible because of the nature of the device studied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center, randomized, controlled, open-label therapeutic trial with two parallel arms.

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 6, 2022
• Study Start: January 18, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

FR (5)