Delivery Clinical Trial
Official title:
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)
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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