Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)

Study Overview
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Brief Summary
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At the moment in France, one delivery on four is induced for a medical indication. In this context, the practitioners are exposed to an additional difficulty when the clinical examination of the patient reveals a unfavorable cervix because the main drug used for the releases cannot be used and the cervix must be previously mature. There is a pharmacological method used and estimated in these indications of cervical maturation: the dinoprostone (Propess®). Other methods using a mechanical process, are under development and of evaluation as it is the case of the probe of dilation with double balloon (Cook®). The population of the obese women is a population in constant increase in France and presenting deliveries to higher risks of maternal and foetal complications. At these patients, the medicinal releases seem also more difficult and at greater risks of failures. The investigators wish compared the efficiency of the cervical ripening balloon to the dinoprostone within the framework of a medical indication in a release with a unfavorable cervix in obese pregnant women.

Official Title
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Pilot, Comparative, Not Randomized, Two Centers Study Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)

Conditions
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Delivery

Intervention / Treatment
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* Device: Cervical ripening balloon
* Drug: Dinoprostone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Term ≥ 37 weeks of amenorrhea Singleton pregnancy Cephalic presentation Medical indication of release and unfavorable cervix (Bishop <6) BM pre-pregnancy ≥ 30 kg/m2 Having given their agreement for the participation of the study Patient receiving social coverage Exclusion Criteria: Age < 18 years Term < 37 weeks of amenorrhea Multiple pregnancy Favorable cervix (Bishop ≥ 6) Contraindication of vaginal delivery: praevia placenta, transverse presentation, cord prolapse Evolutive urinary tract infection (positive urine dip: leukocytes/ nitrites) Not affiliated with a legal protection regime Patient trust, guardianship, under legal protection measure, deprived of freedom Balloon's contraindications: Abnormal pelvis structure Evolutive genital herpes Invasive cervical cancer Anomaly of foetal heart rate Breech presentation Maternal heart disorder Hydramnios Serious and uncontrolled arterial high blood pressure Rupture of membranes Medical histories of hysterotomy, classic uterine section, myomectomy or quite different uterine section of full thickness Presentation above superior pelvic strait Dinoprostone's contraindications: Scarred uterus Prostaglandin's hypersensitivity

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical ripening balloon<br>Prospective | Device: Cervical ripening balloon<br> <br> * Other names: Cook;|
| Active Comparator: Dinoprostone<br>Retrospective | Drug: Dinoprostone<br> <br> * Other names: Propess;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bishop score after 24 hours of maturation |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unfavorable cervix, obese pregnant women