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

Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)

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.

Study Overview

• Status: Completed
• Conditions: Obese; Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • CHU Besançon
  • Trévenans, France
    • Hôpital Nord Franche-Comté

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients of the level III maternity of university hospital center of Besançon and level IIB maternity of regional hospital of Trevenans, France.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean sections	Rate of cesarean sections in each group	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Entry into active phase (dilation to 5-6 cm)	Rate of entry into active phase (dilation to 5-6 cm)	1 year
Complication	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)	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Hopital Nord Franche-Comte

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): December 12, 2020
• Study Completion (Actual): December 12, 2020

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Pregnancy; C-section; BMI; caesarean; Induction of Labor; Dinoprostone; Balloon
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: P/2019/469