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

NCT ID: NCT02615236

Last Updated: 2018-11-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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

Conditions

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Episiotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PERINEAL ULTRASOUND

Perineal ultrasound with a bedside scanner by inserting a the probe into the perineum and reviewed in real-time

Group Type EXPERIMENTAL

perineal ultrasound

Intervention Type DEVICE

transvaginal probe will be used to scan the perineum immediately after vaginal delivery in primiparous women

Clinical diagnosis

Diagnosis of OASIS will be clinically

Group Type ACTIVE_COMPARATOR

Clinical diagnosis

Intervention Type PROCEDURE

diagnosis of OASIS clinically

Interventions

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perineal ultrasound

transvaginal probe will be used to scan the perineum immediately after vaginal delivery in primiparous women

Intervention Type DEVICE

Clinical diagnosis

diagnosis of OASIS clinically

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* primiparous women immediately after vaginal delivery

Exclusion Criteria

* history of anal incontinence
* previous anal sphincteric injuries
* previous anal surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed El Kotb Abdel Fattah

Dr. Ahmed Kotb

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed kotb, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PUS-OASIS

Identifier Type: -

Identifier Source: org_study_id

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