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

Ain Shams University

Status: Unknown

Conditions: Episiotomy

Treatments: Device: perineal ultrasound; Procedure: Clinical diagnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT02615236

PUS-OASIS

Details and patient eligibility

About

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

Full 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

Enrollment: 300 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• primiparous women immediately after vaginal delivery

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

PERINEAL ULTRASOUND

Experimental group

Description:

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

Treatment:

Device: perineal ultrasound

Clinical diagnosis

Active Comparator group

Description:

Diagnosis of OASIS will be clinically

Treatment:

Procedure: Clinical diagnosis