Balloon to Induce Labor in Generous Women. (BIGW)

Toulouse University Hospital

Status and phase: Terminated; Phase 3

Conditions: Maternal Obesity

Treatments: Drug: Oral misoprostol alone; Combination Product: Balloon catheter + oral misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03435458

RC31/16/8911

Details and patient eligibility

About

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.

Full description

The rate of obesity increases continuously in France as in many developing countries. In 2012, in the US, one third of all pregnant women were obese. 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.

Prevalence of post-term is increased in obese pregnant women and the rate of induction of labor is twice the rate of normal-weight women, 42% versus 23% in the 2010 French National Survey.

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.

In a recent randomized clinical trial (RCT), the rate of c-section after labor induction in obese women was not increased in obese women compared to normal-weight women with balloon catheter but it was also increased with prostaglandin E2 (PGE2) and moreover with higher rate of uterine hyperstimulation. Recently, low dose of oral misoprostol (PGE1) has been showed to be the drug with the lowest rate of c-section after induction of labor in all women and balloon catheter to be associated with the lowest rate of hyperstimulation. Because safety of these two specific methods for induction of labor, a comparison 1 to 1 were done recently for induction of labor in singletons with comparable results.

Very few studies have focused on induction of labor in obese women even if the rate of maternal and neonatal complications are higher.

The efficacy of combining these two methods with different mechanism of induction have been showed recently but no study has been published today on obese women. Recently a trial have showed a shorter induction-delivery time with the combination (misoprostol-foley) for induction of labor in the whole population with less need of oxytocin during labor without more complications neither for the mother nor for the baby.An induction will be considered "failed" if at least 12 hours have elapsed since both rupture of membranes and use of a uterine stimulant and the patient remains in latent labor.

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.

Enrollment: 429 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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429 participants in 2 patient groups

Balloon catheter + oral misoprostol

Experimental group

Treatment:

Combination Product: Balloon catheter + oral misoprostol

Oral misoprostol alone

Active Comparator group

Treatment:

Drug: Oral misoprostol alone