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| Name | Class |
|---|---|
| Office of Research on Women's Health (ORWH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of FI | 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. | 6 and 12 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of FI | 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. | 24 weeks postpartum |
| Fecal urgency |
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Inclusion Criteria Assessed by 2 weeks postpartum
Inclusion Criteria at 2 weeks postpartum
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Holly E Richter, PhD, MD | University of Alabama at Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25679358 | Derived | Richter HE, Nager CW, Burgio KL, Whitworth R, Weidner AC, Schaffer J, Zyczynski HM, Norton P, Jelovsek JE, Meikle SF, Spino C, Gantz M, Graziano S, Brubaker L; NICHD Pelvic Floor Disorders Network. Incidence and Predictors of Anal Incontinence After Obstetric Anal Sphincter Injury in Primiparous Women. Female Pelvic Med Reconstr Surg. 2015 Jul-Aug;21(4):182-9. doi: 10.1097/SPV.0000000000000160. |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Fecal urgency will be assessed at 24 weeks based on the one question from the Modified Manchester questionnaire
| 24 weeks postpartum |
| La Jolla |
| California |
| 92037 |
| United States |
| Loyola University | Maywood | Illinois | 60153 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |