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

Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04299854
Acronym
MODOBAT
Enrollment
77
Registered
2020-03-09
Start date
2020-06-11
Completion date
2020-12-12
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor Affected Fetus / Newborn, Obese

Keywords

Induction of Labor, BMI, Obesity, caesarean, C-section, Pregnancy, Balloon, Dinoprostone

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.

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

Sponsors

Hopital Nord Franche-Comte
CollaboratorOTHER
Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cesarean sections1 yearRate of cesarean sections in each group

Secondary

MeasureTime frameDescription
Entry into active phase (dilation to 5-6 cm)1 yearRate of entry into active phase (dilation to 5-6 cm)
Complication1 yearComplication 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026