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

Study 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

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

Conditions
-----------------
Episiotomy

Intervention / Treatment
-----------------
* Device: perineal ultrasound
* Procedure: Clinical diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primiparous women immediately after vaginal delivery Exclusion Criteria: history of anal incontinence previous anal sphincteric injuries previous anal surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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 |