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

Not Applicable

• Conditions: Episiotomy
• Interventions: Procedure: Clinical diagnosis; Device: perineal ultrasound

• Registration Number: NCT02615236
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Study Start: 2016-06
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-16
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• primiparous women immediately after vaginal delivery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical diagnosis	Clinical diagnosis	Diagnosis of OASIS will be clinically
PERINEAL ULTRASOUND	perineal ultrasound	Perineal ultrasound with a bedside scanner by inserting a the probe into the perineum and reviewed in real-time

Primary Outcome Measures

Name	Time	Method
anal incontinence	3 months after delivery	patients will be reviewed for anal incontinence 3 months after delivery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Al Qahirah, Egypt