Status:
TERMINATED
Balloon to Induce Labor in Generous Women.
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Maternal Obesity
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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...
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 obes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
429 Patients enrolled
Trial Details
Trial ID
NCT03435458
Start Date
June 26 2020
End Date
February 2 2023
Last Update
May 15 2023
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63000
2
CHU St Etienne
Saint-Etienne, Auvergne-Rhône-Alpes, France, 42055
3
CHU Tours
Tours, Centre-Val de Loire, France, 37044
4
CHRU Lille
Lille, Hauts-de-France, France, 59020