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Status:

COMPLETED

Behavioral Therapy Of Obstetric Sphincter Tears

Lead Sponsor:

NICHD Pelvic Floor Disorders Network

Collaborating Sponsors:

Office of Research on Women's Health (ORWH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions:

Fecal Incontinence

Eligibility:

FEMALE

18+ years

Brief 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 w...

Detailed Description

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: ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria Assessed by 2 weeks postpartum
  • Vaginal delivery \>= 28 weeks singleton gestation
  • Documented repair to the anal sphincter at delivery
  • First vaginal delivery
  • Ambulatory
  • Able to give informed consent 6 Adult women \>= 18 years of age
  • Inclusion Criteria at 2 weeks postpartum
  • Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease)
  • Pre-pregnancy ano-rectal surgery (e.g., surgery for hemorrhoids, fissures, sphincterotomy)
  • Pre-pregnancy FI (defined as the leakage of liquid/solid stool and mucus \>= once per month for at least 12 weeks prior to this pregnancy)
  • Neurological condition that would predispose to FI (e.g., spinal cord injury, multiple sclerosis)
  • Presence of rectovaginal fistula
  • Any participation in other pharmacologic or behavioral studies for FI
  • Previous pregnancy \>=28 weeks delivered vaginally or by Cesarean section

Exclusion

    Key Trial Info

    Start Date :

    July 1 2010

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2012

    Estimated Enrollment :

    362 Patients enrolled

    Trial Details

    Trial ID

    NCT01166399

    Start Date

    July 1 2010

    End Date

    October 1 2012

    Last Update

    September 10 2020

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294

    2

    University of California San Diego

    La Jolla, California, United States, 92037

    3

    Loyola University

    Maywood, Illinois, United States, 60153

    4

    Duke University

    Durham, North Carolina, United States, 27710