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Delayed inclusion
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical ripening balloon | Experimental | Prospective |
|
| Dinoprostone | Active Comparator | Retrospective |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical ripening balloon | Device |
|
| |
| Dinoprostone |
| Measure | Description | Time Frame |
|---|---|---|
| Bishop Score After 24 Hours of Maturation | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Balloon's contraindications:
Dinoprostone's contraindications:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume DUCARME, PH | Centre Hospitalier Departemental Vendee | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Vendée | La Roche-sur-Yon | 85925 | France | |||
| Centre Hospitalier |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervical Ripening Balloon | Prospective Cervical ripening balloon |
| FG001 | Dinoprostone | Retrospective Dinoprostone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| Le Mans |
| France |
| COMPLETED |
|
| NOT COMPLETED |
|
The sponsor took the decision to stop the inclusions prematurely as of 23/11/2016. No statistical analysis was performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervical Ripening Balloon | Prospective Cervical ripening balloon |
| BG001 | Dinoprostone | Retrospective Dinoprostone |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The sponsor took the decision to stop the inclusions prematurely as of 23/11/2016. No statistical analysis was performed. | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | The sponsor took the decision to stop the inclusions prematurely as of 23/11/2016. No statistical analysis was performed. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bishop Score After 24 Hours of Maturation | Data were not collected. | Posted | 24 hours |
|
|
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Death, serious adverse event and other (non serious adverse event) were not assessed for the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervical Ripening Balloon | Prospective Cervical ripening balloon | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Dinoprostone | Retrospective Dinoprostone | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Guillaume DUCARME | Centre Hospitalier Départemental Vendée | 02 51 44 61 61 | guillaume.ducarme@ght85.fr |
| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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