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NCT01166399 · ClinicalTrials.gov registry record
Behavioral Therapy Of Obstetric Sphincter Tears
A clinical trial, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- 362
- Enrollment target
NCT01166399: Completed study, sponsored by NICHD Pelvic Floor Disorders Network.
NCT01166399 is a clinical trial that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 362 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01166399 has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- 362 participants
- Enrollment target
Study Summary
The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12 and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks postpartum, subjects will be contacted by telephone for evaluation of FI symptoms. Symptoms of FI will be defined by at least monthly symptoms of leakage of liquid, solid stool, and mucus. Flatal incontinence will be assessed at 24 weeks, based on the Fecal Incontinence Severity Index, and fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire. A sample size of approximately 400-450 subjects will be enrolled.
Primary Outcome
The primary aim for this study is to determine the incidence of FI symptoms (based on the FISI)at 6 and 12 weeks postpartum in primiparous women sustaining an OASI.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-10 |
What the finished NCT01166399 record still lists
NCT01166399 is an observational study that tracks outcomes without assigning an intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01166399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01166399 about?
NCT01166399 is a clinical study titled "Behavioral Therapy Of Obstetric Sphincter Tears". The study design will be a cohort study to determine the incidence of FI symptoms at 6, 12 and 24 weeks postpartum in primiparous women sustaining an OASI. At 6, 12 and 24 weeks postpartum, subjects will be contacted by telephone for evaluation of FI symptoms. Symptoms of FI will be defined by at le...
What is the current status of trial NCT01166399?
This trial is currently completed. The enrollment target is 362 participants. The study started on 2010-07. Estimated completion is 2012-10.
Who is sponsoring clinical trial NCT01166399?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
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