NCT04299854

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

Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 77 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Induction of Labor Affected Fetus / Newborn
• Obese

Interventions

Type	Name	Description
DRUG	Dinoprostone 10mg	Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina
DEVICE	single balloon Foley catheter	A single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os

Timeline

• Start date: 2020-06-11
• Primary completion: 2020-12-12
• Completion: 2020-12-12
• First posted: 2020-03-09
• Last updated: 2021-05-03

Locations

2 sites across 1 country: France