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OpenTrials
Completed

NCT Number: NCT01310426

Risk Factors for Anal Sphincter Damage During Vaginal Delivery

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).

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Key information

Conditions

Anal Sphincter Injury Digestive System Diseases Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

17 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Anal sphincter disruption before birth

Treatment and study plan

3D transperineal Ultrasound

Other

3D transperineal Ultrasound after vaginal delivery

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Acronym: AnaSphRF

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 8, 2011
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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