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

NCT05568745 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2023-01-25

No results posted yet for this study

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

Interventions

DEVICE

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

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.

DRUG

Oxytocin

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.

DRUG

Misoprostol Oral Tablet

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.

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Denis Gallot · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2025-02-28
Completion
2026-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05568745 on ClinicalTrials.gov