Risk Factors for Anal Sphincter Damage During Vaginal Delivery (AnaSphRF)
This study is currently recruiting participants.
Verified January 2012 by Hadassah Medical Organization
Sponsor:
Hadassah Medical Organization
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01310426
First received: March 1, 2011
Last updated: November 7, 2012
Last verified: January 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 1, 2011 | ||||
| Last Updated Date | November 7, 2012 | ||||
| Start Date ICMJE | March 2011 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Anal sphincter damage [ Time Frame: up to one year after vaginal birth ] [ Designated as safety issue: No ] Anal Sphincter Damage wil be assessed by usin 3D transperineal US in women after vaginal delivery |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01310426 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Risk Factors for Anal Sphincter Damage During Vaginal Delivery | ||||
| Official Title ICMJE | Risk Factors for Anal Sphincter Damage During Vaginal Delivery | ||||
| Brief Summary | Vaginal delivery may cause various levels of damage to the anal sphincter. According to the literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal delivery suffer from fecal incontinence. This has an adverse effect on the quality of life. Different risk factors such as: first births, instrumental delivery, high birth weight, prolonged second stage, epidural anesthesia etc. were assessed and found to be associated with anal sphincter disruption. The purpose of this study is to assess risk factors for anal sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D transperineal US). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The study population are women between ages 17 and 40 after their first delivery at the Hadassa Mount Scopus hospital in Jerusalem, Israel. |
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| Condition ICMJE |
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| Intervention ICMJE | Other: 3D transperineal Ultrasound
3D transperineal Ultrasound after vaginal delivery |
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| Study Group/Cohort (s) | anal sphincter damage
After assessing women after vaginal delivery, a comparison will be made between those with anal sphincter damage and those women without.
Intervention: Other: 3D transperineal Ultrasound |
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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 | 500 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 17 Years to 42 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01310426 | ||||
| Other Study ID Numbers ICMJE | AnaSphRF-HMO-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hadassah Medical Organization | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | January 2012 | ||||
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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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