Balloon to Induce Labor in Generous Women.

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The rate of obesity increases continuously in France as in many developing countries.The risk of cesarean delivery is increased in obese compared to normal-weight women and postpartum complications as infections, thromboembolic events and related maternal death, are more common among obese women who deliver by cesarean than both normal-weight women with caesarean deliveries and obese women with vaginal deliveries. Unfortunately, obesity is associated with a higher rate of failed induction requiring a cesarean delivery and especially in nulliparous.

Methods of induction for obese women have to be improved to decrease the c-section rate but investigators should also be cautious on the type and dose of PG not to affect the neonatal wellbeing associated with uterine hyperstimulation.

The aim of this study is to demonstrate the efficacy of the association of mechanical and pharmacological cervical ripening (balloon catheter plus 50 µg oral prostaglandin E1) versus pharmacological cervical ripening alone (50 µg oral prostaglandin E1) to reduce the rate of caesarean sections in nulliparous obese women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• female

• pregestational BMI ≥ 30 kg/m2 (weight/height2)

• singleton pregnancy with cephalic presentation

• nulliparous

• ≥ 36 weeks gestational age

• decision of induction of labor

• bishop score ≤ 5

• ≤ 3 uterine contractions / 10 min

• ≥ 18 years of age

• personally signed and dated informed consent document

• ability to comply with the requirement of the study

• insurance coverage

Exclusion Criteria:

• deceleration on Fetal Heart Rate (FHR)

• placenta praevia

• bleeding

• premature rupture of membrane

• chorioamnionitis

• allergy to prostaglandins

• contraindication to ballon

• active genital herpes infection

• HIV infection

• fetal serious congenital anomaly

• patient subject to a legal protection order