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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02615236
Enrollment
300
Registered
2015-11-26
Start date
2016-06-30
Completion date
2018-12-31
Last updated
2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episiotomy

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

Interventions

transvaginal probe will be used to scan the perineum immediately after vaginal delivery in primiparous women

diagnosis of OASIS clinically

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* primiparous women immediately after vaginal delivery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
anal incontinence3 months after deliverypatients will be reviewed for anal incontinence 3 months after delivery

Secondary

MeasureTime frameDescription
pain score3 and 12 month after deliveryvisual analogue scale will be used
questionnaire for effect on quality of life3 and 12 month after deliveryquestionnaire will be used to asses how anal incontinence affect the quality of life

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026