Modality of Induction of Labor in Obese Women at Term (MODOBAT)
MODOBAT
Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)
1 other identifier
observational
77
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2020
CompletedFirst Posted
Study publicly available on registry
March 9, 2020
CompletedStudy Start
First participant enrolled
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2020
CompletedMay 3, 2021
March 1, 2021
6 months
March 5, 2020
April 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cesarean sections
Rate of cesarean sections in each group
1 year
Secondary Outcomes (2)
Entry into active phase (dilation to 5-6 cm)
1 year
Complication
1 year
Study Arms (2)
Vaginal Dinoprostone
Induction of labor by 10mg of vaginal dinoprostone
Single Balloon Foley Catheter
Induction of labor by single balloon Foley catheter
Interventions
Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina
A single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os
Eligibility Criteria
Patients of the level III maternity of university hospital center of Besançon and level IIB maternity of regional hospital of Trevenans, France.
You may qualify if:
- Age ≥ 18 years
- Medical indication of induction of labor
- BMI ≥ 30 kg / m2
- Bishop \< 6
- Singleton
- Gestational age \> 36 SA + 6j
- Cephalic presentation
You may not qualify if:
- Adults under guardianship or curatorship
- Scarred uterus
- Placenta praevia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU Besançon
Besançon, France
Hopital Nord Franche-Comté
Trévenans, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2020
First Posted
March 9, 2020
Study Start
June 11, 2020
Primary Completion
December 12, 2020
Study Completion
December 12, 2020
Last Updated
May 3, 2021
Record last verified: 2021-03