Behavioral Therapy Of Obstetric Sphincter Tears (BOOST)
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|ClinicalTrials.gov Identifier: NCT01166399|
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : September 30, 2013
|Condition or disease|
The primary aim of the "BOOST Cohort Study" is to determine the incidence of FI symptoms at 6 and 12 weeks postpartum in primiparous women sustaining an OASI.
Secondary aims of the cohort study are:
- To determine the incidence rates of FI symptoms at 24 weeks post delivery in primiparous women sustaining an OASI
- To examine the relationship between the modified WHO sphincter tear classification types and FI symptoms
- To examine predictors (socio-demographic, physical and clinical) associated with WHO sphincter tear classifications (3a, 3b and 4) and predictors associated with FI symptoms
- To evaluate the incidence of fecal urgency and flatal incontinence at 24 weeks postpartum in primiparous women sustaining an OASI.
|Study Type :||Observational|
|Actual Enrollment :||362 participants|
|Official Title:||BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||October 2012|
Primiparous women with an obstetric anal sphincter tear
Subjects in this trial will be primiparous women who underwent anal sphincter repair at the time of a singleton vaginal delivery. Sphincter tears will be clinically characterized at the time of delivery as <50% tear through the anal sphincter (modified WHO 3a), >50% (modified WHO 3b), or complete tear through the anal sphincter (4th degree). Subjects in this study will not have receive study interventions.
- Incidence of FI [ Time Frame: 6 and 12 months postpartum ]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.
- Incidence of FI [ Time Frame: 24 weeks postpartum ]A secondary aim for this study is to determine the incidence of FI symptoms (based on the FISI) at 24 weeks postpartum in primiparous women sustaining an OASI.
- Fecal urgency [ Time Frame: 24 weeks postpartum ]Fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166399
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of California San Diego|
|La Jolla, California, United States, 92037|
|United States, Illinois|
|Maywood, Illinois, United States, 60153|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15260|
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Study Chair:||Holly E Richter, PhD, MD||University of Alabama at Birmingham|