Risk Factors for Anal Sphincter Damage During Vaginal Delivery (AnaSphRF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01310426
First received: March 1, 2011
Last updated: November 7, 2012
Last verified: January 2012
  Purpose

Vaginal delivery may cause various levels of damage to the anal sphincter. According to the literature, one third - two third of women diagnosed with 3rd degree rupture during vaginal delivery suffer from fecal incontinence. This has an adverse effect on the quality of life. Different risk factors such as: first births, instrumental delivery, high birth weight, prolonged second stage, epidural anesthesia etc. were assessed and found to be associated with anal sphincter disruption. The purpose of this study is to assess risk factors for anal sphincter disruption by new methods such as three-Dimensional transperineal ultrasound (3D transperineal US).


Condition Intervention
Anal Sphincter Injury
Fecal Incontinence
Other: 3D transperineal Ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors for Anal Sphincter Damage During Vaginal Delivery

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Anal sphincter damage [ Time Frame: up to one year after vaginal birth ] [ Designated as safety issue: No ]
    Anal Sphincter Damage wil be assessed by usin 3D transperineal US in women after vaginal delivery


Estimated Enrollment: 500
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
anal sphincter damage
After assessing women after vaginal delivery, a comparison will be made between those with anal sphincter damage and those women without.
Other: 3D transperineal Ultrasound
3D transperineal Ultrasound after vaginal delivery

  Eligibility

Ages Eligible for Study:   17 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population are women between ages 17 and 40 after their first delivery at the Hadassa Mount Scopus hospital in Jerusalem, Israel.

Criteria

Inclusion Criteria:

  • First Delivery
  • Vaginal Delivery
  • Birthweight > 3000
  • Singleton pregnancy

Exclusion Criteria:

  • Anal sphincter disruption before birth
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310426

Contacts
Contact: Hadas Lemberg, PhD 0097226777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Hadas Lemberg, PhD    0097226777572    lhadas@hadassah.org.il   
Principal Investigator: Drorith Hochner-Celnikier, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Drorith Hochner, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01310426     History of Changes
Other Study ID Numbers: AnaSphRF-HMO-CTIL
Study First Received: March 1, 2011
Last Updated: November 7, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Anal Sphincter injury
Fecal Incontinence

Additional relevant MeSH terms:
Fecal Incontinence
Wounds and Injuries
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014