Risk Factors for Anal Sphincter Damage During Vaginal Delivery

NCT01310426 | Completed

• 1 other identifier: AnaSphRF-HMO-CTIL
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Anal Sphincter Injury; Fecal Incontinence

Keywords

Anal Sphincter injury; Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• Anal sphincter damage

  Anal Sphincter Damage wil be assessed by usin 3D transperineal US in women after vaginal delivery

  up to one year after vaginal birth

Study Arms (1)

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

Interventions

3D transperineal Ultrasound OTHER

3D transperineal Ultrasound after vaginal delivery

anal sphincter damage

Eligibility Criteria

• Age: 17 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Anal sphincter disruption before birth

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Drorith Hochner, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 8, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

IL (1)