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Completed

NCT Number: NCT01166399

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 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

NICHD Pelvic Floor Disorders Network

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Office of Research on Women's Health (ORWH)

Registry information

Official study title

BOOST: Behavioral Therapy of Obstetric Sphincter Tears: A Cohort Study

Acronym: BOOST

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 21, 2010
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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