Modality of Induction of Labor in Obese Women at Term (MODOBAT)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Induction of Labor Affected Fetus / Newborn; Obese

Treatments: Device: single balloon Foley catheter; Drug: Dinoprostone 10mg

Study type: Observational

Funder types: Other

Identifiers

NCT04299854

P/2019/469

Details and patient eligibility

About

In normal-weight patients, numerous studies show an equivalence of efficacy between dinoprostone and balloon to induce labor. In obese patients, this efficacy is not known, although inductions of labor are more frequent. MODOBAT aims to describe the ability to obtain a vaginal delivery of two modality of induction of labor (vaginal dinoprostone and single balloon Foley catheter) in obese women at term.

Full description

Obesity has for several decades become a global epidemic in developed countries. In case of pregnancy, obesity leads to an increased risk of obstetric complications, the indications of induction of labor are then more frequent. Unfortunately the rate of failed induction is also higher and therefore the risk of caesarean section is increased in obese women compared to normal-weight patients when induction of labor is indicated. However, in this context effectiveness of each mode of induction is not known. Some retrospective studies would suggest that the balloon would be more effective because it would not be affected by the increase in fat mass but this result are not , but the to confirm this hypothesis.

The aim of this study is to describe the caesarean section rate in induction of labor by vaginal dinoprostone and single balloon Foley catheter in obese women. Patients in the vaginal dinoprostone arm will be included retrospectively and patients in the single balloon Foley catheter arm will be included prospectively.

Enrollment: 77 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Medical indication of induction of labor
• BMI ≥ 30 kg / m2
• Bishop < 6
• Singleton
• Gestational age > 36 SA + 6j
• Cephalic presentation

Exclusion criteria

• Adults under guardianship or curatorship
• Scarred uterus
• Placenta praevia

Trial design

77 participants in 2 patient groups

Vaginal Dinoprostone

Description:

Induction of labor by 10mg of vaginal dinoprostone

Treatment:

Drug: Dinoprostone 10mg

Single Balloon Foley Catheter

Description:

Induction of labor by single balloon Foley catheter

Treatment:

Device: single balloon Foley catheter