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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02615236
Other study ID # PUS-OASIS
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Completed NCT00070720 - Improving Perinatal Care in Latin America Phase 4
Completed NCT03084549 - Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain Phase 3
Not yet recruiting NCT06415877 - The Effect of the Modified Simulation Model on Self-Efficacy, Anxiety, and Academic Motivation in Episiotomy Training N/A
Recruiting NCT05345600 - MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery N/A
Recruiting NCT02847936 - Efficacy of Triclosan-coated Sutures in the Episiotomy Phase 4
Withdrawn NCT02796547 - Effect of Levobupivacaine Infiltration on the Post Partum Perineal Pain in Episiotomy, in Primiparous Women After Instrumental Delivery Phase 2
Completed NCT02905695 - Post-partum Perineal Pain - Chirocaine® Phase 4
Not yet recruiting NCT05905263 - The Effect of Virtual Reality Application on Student Satisfaction, Self-Confidence, and Anxiety Levels N/A
Not yet recruiting NCT03780530 - Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair Phase 3
Completed NCT02911779 - The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor N/A
Completed NCT02608671 - Adhesive Tape in Episiotomy Repair Phase 4
Completed NCT05776849 - Flipped Classroom in Episiotomy Education N/A
Completed NCT00265421 - Study of Different Suturing Techniques for Perineal Repair After Delivery N/A
Completed NCT05486624 - The Effect of Reiki Application on Episiotomy and Perineal Pain N/A
Completed NCT00196508 - A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth Phase 3