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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01310426
First received: March 1, 2011
Last updated: November 7, 2012
Last verified: January 2012

March 1, 2011
November 7, 2012
March 2011
January 2013   (final data collection date for primary outcome measure)
Anal sphincter damage [ Time Frame: up to one year after vaginal birth ] [ Designated as safety issue: No ]
Anal Sphincter Damage wil be assessed by usin 3D transperineal US in women after vaginal delivery
Same as current
Complete list of historical versions of study NCT01310426 on ClinicalTrials.gov Archive Site
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Risk Factors for Anal Sphincter Damage During Vaginal Delivery
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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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

The study population are women between ages 17 and 40 after their first delivery at the Hadassa Mount Scopus hospital in Jerusalem, Israel.

  • Anal Sphincter Injury
  • Fecal Incontinence
Other: 3D transperineal Ultrasound
3D transperineal Ultrasound after vaginal delivery
anal sphincter damage
After assessing women after vaginal delivery, a comparison will be made between those with anal sphincter damage and those women without.
Intervention: Other: 3D transperineal Ultrasound
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Anal sphincter disruption before birth
Female
17 Years to 42 Years
Yes
Contact: Hadas Lemberg, PhD 0097226777572 lhadas@hadassah.org.il
Israel
 
NCT01310426
AnaSphRF-HMO-CTIL
No
Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Drorith Hochner, MD Hadassah Medical Organization
Hadassah Medical Organization
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP