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Clinical Trials/NCT02615236
NCT02615236
Unknown
Not Applicable

Prospective Evaluation of Perineal Ultrasound in Thr Delivery Room to Improve the Diagnosis of OASIS

Ain Shams University1 site in 1 country300 target enrollmentJune 2016
ConditionsEpisiotomy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Episiotomy
Sponsor
Ain Shams University
Enrollment
300
Locations
1
Primary Endpoint
anal incontinence
Last Updated
7 years ago

Overview

Brief Summary

The aim of the study is to evaluate the role of routine perineal scan using 2D ultrasound immediatly after delivery to diagnose hidden perineal trauma that might affect patient's fecal continance

Detailed Description

In countries where there is high prevalence of doing episiotomy in primiparous women, the incidence of sustained obstetric anal sphincter injuries is increasing. When the tear extend beyond the external anal sphincter its called 'OASIS' that might lead to either immediate of delayed anal incontinence. Anal incontinence is associated with significant medical, hygiene and social problems. Use of perineal ultrasound as a bedside test immediately after vaginal delivery could improve the diagnosis and determining the degree of these perineal traumas. This increased detection could lead to improved primary repair of the external and internal anal sphincter resulting in reduced rates of anal incontinence and improved quality of life for women

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed El Kotb Abdel Fattah

Dr. Ahmed Kotb

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • primiparous women immediately after vaginal delivery

Exclusion Criteria

  • history of anal incontinence
  • previous anal sphincteric injuries
  • previous anal surgery

Outcomes

Primary Outcomes

anal incontinence

Time Frame: 3 months after delivery

patients will be reviewed for anal incontinence 3 months after delivery

Secondary Outcomes

  • pain score(3 and 12 month after delivery)
  • questionnaire for effect on quality of life(3 and 12 month after delivery)

Study Sites (1)

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