Clinical trial NCT03435458: Balloon to Induce Labor in Generous Women.
Official title: Balloon to Induce Labor in Generous Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Maternal Obesity
Keywords: Induced labor
Maternal obesity
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 429
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized, multicentre, open-label, controlled trial comparing association of balloon catheter plus oral prostaglandin E1 versus oral prostaglandin E1 alone to induce labor in a 1:1 randomization of nulliparous obese women.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Efficacy of the association of mechanical and low dose oral misoprostol compared to oral misoprostol alone, to reduce the rate of caesarean section of all indications in obese women.
timeFrame: Day 0 to day 2
Secondary outcomes:
measure: Effectiveness criteria.
timeFrame: Day 0 to day 2
measure: Cost analysis.
timeFrame: Day 0 to day 2
measure: Resources consumption collection.
timeFrame: Day 0 to day 2
measure: Costs valuation.
timeFrame: Day 0 to day 2
measure: Cost-effectiveness analysis.
timeFrame: Day 0 to day 2
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
state: Auvergne-Rhône-Alpes
city: Saint-Étienne
country: France
facility: CHU St Etienne
state: Auvergne-Rhône-Alpes
city: Tours
country: France
facility: CHU Tours
state: Centre-Val De Loire
city: Lille
country: France
facility: CHRU Lille
state: Hauts-de-France
city: Clamart
country: France
facility: CHU Antoine Beclère
state: Ile-de-France
city: Le Kremlin-Bicêtre
country: France
facility: CHU Kremlin Bicêtre
state: Ile-de-France
city: Paris
country: France
facility: Centre hospitalier St Joseph
state: Ile-de-France
city: Poissy
country: France
facility: CHI Poissy
state: Ile-de-France
city: Saint-Denis
country: France
facility: CHU Saint Denis de la Reunion
state: La Réunion
city: Saint-Pierre
country: France
facility: CHU St Pierre de la Reunion
state: La Réunion
city: Toulouse
country: France
facility: CHU de Toulouse
state: Midi-Pyrénées
city: Bordeaux
country: France
facility: CHU Bordeaux
state: Nouvelle Aquitaine
city: Nîmes
country: France
facility: CHU Nimes
state: Occitanie
city: Marseille
country: France
facility: Hôpital St Joseph
state: Provence-Alpes-Côte d'Azur
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes
city: Poitiers
country: France
facility: CHU Poitiers
city: Fort de France
country: Martinique
facility: CHU Fort de France
Study officials:
affiliation: CHU Toulouse
name: Christophe Vayssiere, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
citation: Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.
citation: McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002.