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

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Oct 3, 2022

Keywords

ClinConnect Summary

This clinical trial, called RUBAPRO2, is investigating two different methods for inducing labor in women who experience premature rupture of membranes (PROM) at term. PROM means that the water has broken before labor starts, which can happen in about 6-22% of pregnancies. In this study, researchers want to find out if using a combination of a balloon catheter and oxytocin (a hormone that helps with contractions) is more effective at getting women to deliver within 24 hours compared to taking oral misoprostol, a medication that also helps induce labor.

To participate in the trial, women must be over 18 years old, pregnant with a single baby at least 37 weeks along, and have PROM without going into labor for at least 12 hours. They should also have a cervix that is not yet ready for labor. Participants will be monitored closely, and their satisfaction will be assessed before they leave the hospital. This trial aims to help doctors understand better ways to induce labor in women with PROM, which could ultimately lead to safer deliveries.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • Suspicion or confirmation of a scarred uterus following past surgical intervention
• • Renal insufficiency
• • Malformation of the uterus
• * Contraindication to balloon:
• • Vasa praevia, placenta praevia
• • Invasive cervical cancer
• • Contraindication to oxytocin
• • Allergy or hypersensibility
• • Dystocia
• • Fragility or excessive distension of the uterus
• • Uterine hypertonia or fetal distress when delivery is not imminent
• • Cardiovascular disorders and severe preeclampsia
• • Predisposition to amniotic embolism (in utero fetal demise, abruption).
• • Patient subject to a legal protection order (curatorship or tutorship)
• • Refusal to participate