Risk Factors for Anal Sphincter Damage During Vaginal Delivery

Fecal Incontinence Clinical Trial

— AnaSphRF  

Official title:

Risk Factors for Anal Sphincter Damage During Vaginal Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310426
• Other study ID #: AnaSphRF-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: March 1, 2011
• Last updated: July 26, 2015
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: July 2015
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 42 Years

Eligibility

Inclusion Criteria:

• First Delivery

• Vaginal Delivery

• Birthweight > 3000

• Singleton pregnancy

Exclusion Criteria:

• Anal sphincter disruption before birth

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anal Sphincter Injury
• Fecal Incontinence

Intervention

Other:
• 3D transperineal Ultrasound
3D transperineal Ultrasound after vaginal delivery

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No