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

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: Episiotomy
• Intervention / Treatment: Device: perineal ultrasound; Procedure: Clinical diagnosis

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

Study Locations

• Egypt
  • Al Qahirah
    • Cairo, Al Qahirah, Egypt
      • Faculty of Medicine, Ain Shams University

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

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

Study record dates

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