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

Completed

• Conditions: Induction of Labor Affected Fetus / Newborn; Obese
• Interventions: Drug: Dinoprostone 10mg; Device: single balloon Foley catheter

• Registration Number: NCT04299854
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

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 Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-09
• Study Start: 2020-06-11
• Primary Completion: 2020-12-12
• Study Completion: 2020-12-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaginal Dinoprostone	Dinoprostone 10mg	Induction of labor by 10mg of vaginal dinoprostone
Single Balloon Foley Catheter	single balloon Foley catheter	Induction of labor by single balloon Foley catheter

Primary Outcome Measures

Name	Time	Method
Cesarean sections	1 year	Rate of cesarean sections in each group

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Hopital Nord Franche-Comté; 🇫🇷 Trévenans, France

CHU Besançon; 🇫🇷 Besançon, France