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

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ClinicalTrials.gov Identifier: NCT01310426
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:
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 or disease Intervention/treatment
Anal Sphincter Injury Fecal Incontinence Other: 3D transperineal Ultrasound

Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors for Anal Sphincter Damage During Vaginal Delivery
Study Start Date : March 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Anal sphincter damage [ Time Frame: up to one year after vaginal birth ]
    Anal Sphincter Damage wil be assessed by usin 3D transperineal US in women after vaginal delivery



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Ages Eligible for Study:   17 Years to 42 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

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): NCT01310426


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Drorith Hochner, MD Hadassah Medical Organization

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01310426     History of Changes
Other Study ID Numbers: AnaSphRF-HMO-CTIL
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

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

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