An interventional study of perineal ultrasound and Clinical diagnosis in Episiotomy, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-16.
Sponsored by Ain Shams University · Not applicable, Interventional, and Diagnostic
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
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
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Perineal ultrasound with a bedside scanner by inserting a the probe into the perineum and reviewed in real-time
Device: perineal ultrasound
Diagnosis of OASIS will be clinically
Procedure: Clinical diagnosis
transvaginal probe will be used to scan the perineum immediately after vaginal delivery in primiparous women
diagnosis of OASIS clinically
anal incontinence
patients will be reviewed for anal incontinence 3 months after delivery
Time frame: 3 months after delivery
pain score
visual analogue scale will be used
Time frame: 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
Time frame: 3 and 12 month after delivery
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Ain Shams University