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

November 15, 2018 updated by: Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Qahirah
      • Cairo, Al Qahirah, Egypt
        • Faculty of medicine, Ain Shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • primiparous women immediately after vaginal delivery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PERINEAL ULTRASOUND
Perineal ultrasound with a bedside scanner by inserting a the probe into the perineum and reviewed in real-time
Device: perineal ultrasound
transvaginal probe will be used to scan the perineum immediately after vaginal delivery in primiparous women
Active Comparator: Clinical diagnosis
Diagnosis of OASIS will be clinically
Procedure: Clinical diagnosis
diagnosis of OASIS clinically

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anal incontinence
Time Frame: 3 months after delivery
patients will be reviewed for anal incontinence 3 months after delivery
3 months after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 3 and 12 month after delivery
visual analogue scale will be used
3 and 12 month after delivery
questionnaire for effect on quality of life
Time Frame: 3 and 12 month after delivery
questionnaire will be used to asses how anal incontinence affect the quality of life
3 and 12 month after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed kotb, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PUS-OASIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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