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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT04299854

Collaborator

Hopital Nord Franche-Comte (Other)

Enrollment

Locations

Actual Duration (Months)

38.5

Patients Per Site

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Induction of Labor Affected Fetus / Newborn Obese	Drug: Dinoprostone 10mg Device: single balloon Foley catheter

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.

Study Design

Study Type:

Observational

Actual Enrollment :

77 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)

Actual Study Start Date :

Jun 11, 2020

Actual Primary Completion Date :

Dec 12, 2020

Actual Study Completion Date :

Dec 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Vaginal Dinoprostone Induction of labor by 10mg of vaginal dinoprostone	Drug: Dinoprostone 10mg Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina
Single Balloon Foley Catheter Induction of labor by single balloon Foley catheter	Device: single balloon Foley catheter A single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os

Arm

Intervention/Treatment

Vaginal Dinoprostone

Induction of labor by 10mg of vaginal dinoprostone

Drug: Dinoprostone 10mg

Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina

Single Balloon Foley Catheter

Induction of labor by single balloon Foley catheter

Device: single balloon Foley catheter

A single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os

Outcome Measures

Primary Outcome Measures

Cesarean sections [1 year]
Rate of cesarean sections in each group

Secondary Outcome Measures

Entry into active phase (dilation to 5-6 cm) [1 year]
Rate of entry into active phase (dilation to 5-6 cm)
Complication [1 year]
Complication rate = composite criteria including : Hypercinesia / hypertonia rate Rate of fetal heart rate anomalies Fever rate during work Rate of uterine ruptures Postpartum hemorrhage rate Rate of infectious complications in immediate postpartum (fever> 38.5 ° or wall abscess or endometritis defined by a fever greater than 38 ° with pain in uterine mobilization and foul or foul-smelling lochia)