Perineal Echography in the Delivery Room for the Detection of Anal Lesions
This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01320995
First received: March 22, 2011
Last updated: April 21, 2013
Last verified: March 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 22, 2011 | ||||||||
| Last Updated Date | April 21, 2013 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Presence/absence of anal incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ] Anal incontinence is defined as a Wexner score > 4 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01320995 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Perineal Echography in the Delivery Room for the Detection of Anal Lesions | ||||||||
| Official Title ICMJE | Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study | ||||||||
| Brief Summary | The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Parturition | ||||||||
| Intervention ICMJE | Procedure: Perineal ultrasound
Perineal ultrasound is performed after delivery in order to better detect sphincter lesions. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 586 | ||||||||
| Estimated Completion Date | December 2015 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01320995 | ||||||||
| Other Study ID Numbers ICMJE | AOI/2010/VL-02, 2011-A00050-41 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Centre Hospitalier Universitaire de Nīmes | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nīmes | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nīmes | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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