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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-11

Study Completion Date

2020-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter

NCT01962831

Obesity Pregnancy Labor, Induced

COMPLETED NA

Balloon to Induce Labor in Generous Women.

NCT03435458

Maternal Obesity

TERMINATED PHASE3

Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Trial of Two Strategies

NCT04452747

Pregnancy Related

COMPLETED NA

Obesity Study to Assess Induction of Labor

NCT03796416

Induction of Labor Affected Fetus / Newborn

WITHDRAWN NA

Labor Induction With Dinoprostone in Oppose to Cervical Ripening Balloon as a Factor of BMI.

NCT03033264

Induction of Labor

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Induction of Labor Affected Fetus / Newborn Obese

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vaginal Dinoprostone

Induction of labor by 10mg of vaginal dinoprostone

Dinoprostone 10mg

Intervention Type DRUG

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

single balloon Foley catheter

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dinoprostone 10mg

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

Intervention Type DRUG

single balloon Foley catheter

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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