Risk Factors for Anal Sphincter Damage During Vaginal Delivery

NCT ID: NCT01310426

Last Updated: 2015-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Anal Sphincter Injury Fecal Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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anal sphincter damage

After assessing women after vaginal delivery, a comparison will be made between those with anal sphincter damage and those women without.

3D transperineal Ultrasound

Intervention Type OTHER

3D transperineal Ultrasound after vaginal delivery

Interventions

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3D transperineal Ultrasound

3D transperineal Ultrasound after vaginal delivery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Anal sphincter disruption before birth
Minimum Eligible Age

17 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Drorith Hochner, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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AnaSphRF-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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