Balloon to Induce Labor in Generous Women.

  • STATUS
    Recruiting
  • End date
    Jun 26, 2023
  • participants needed
    774
  • sponsor
    University Hospital, Toulouse
Updated on 26 January 2021

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 g oral prostaglandin E1) versus pharmacological cervical ripening alone (50 g oral prostaglandin E1) to reduce the rate of caesarean sections in nulliparous obese women.

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 g oral prostaglandin E1) versus pharmacological cervical ripening alone (50 g oral prostaglandin E1) to reduce the rate of caesarean sections in nulliparous obese women.

Details
Condition Maternal Obesity
Treatment Balloon catheter + oral misoprostol, Oral misoprostol alone
Clinical Study IdentifierNCT03435458
SponsorUniversity Hospital, Toulouse
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

female
pregestational BMI 30 kg/m2 (weight/height2)
singleton pregnancy with cephalic presentation
nulliparous
weeks gestational age
decision of induction of labor
bishop score 5
uterine contractions / 10 min
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
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