Trials / Terminated
TerminatedNCT02649920
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)
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)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Centre Hospitalier Departemental Vendee · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cervical ripening balloon | |
| DRUG | Dinoprostone |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2016-01-08
- Last updated
- 2024-08-15
- Results posted
- 2024-08-15
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02649920. Inclusion in this directory is not an endorsement.