Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT02649920
Status:
TERMINATED
Last Update Posted:
2024-08-15
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
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)
Sponsor:
Centre Hospitalier Departemental Vendee
Organization:
Study Overview
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)
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Delayed inclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BALLODINO
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: