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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)

Conditions
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Induction of Labor Affected Fetus / Newborn, Obese

Intervention / Treatment
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* Drug: Dinoprostone 10mg
* Device: single balloon Foley catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaginal Dinoprostone<br>Induction of labor by 10mg of vaginal dinoprostone | Drug: Dinoprostone 10mg<br>* Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina<br>|
| Single Balloon Foley Catheter<br>Induction of labor by single balloon Foley catheter | Device: single balloon Foley catheter<br>* A single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induction of Labor, BMI, Obesity, caesarean, C-section, Pregnancy, Balloon, Dinoprostone