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

Episiotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02615236
• Other study ID #: PUS-OASIS
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• primiparous women immediately after vaginal delivery

Exclusion Criteria:

• history of anal incontinence

• previous anal sphincteric injuries

• previous anal surgery

Related Conditions & MeSH terms

• Episiotomy

Intervention

Device:
• perineal ultrasound
transvaginal probe will be used to scan the perineum immediately after vaginal delivery in primiparous women

Procedure:
• Clinical diagnosis
diagnosis of OASIS clinically

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anal incontinence	patients will be reviewed for anal incontinence 3 months after delivery	3 months after delivery
Secondary	pain score	visual analogue scale will be used	3 and 12 month after delivery
Secondary	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