Comparison of the accuracy of Episcissor-60 with Mayo scissors in performing a mediolateral episiotomy- a randomized control trial for a duaration of 1 year in a tertiary care center.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- to assess significance of the accurately angled of episiotomy with the use of Episcissor-60 in reduction in obstetric anal sphincter injuries
Study Overview
Brief Summary
Episiotomy is the most commonly performed procedure, and an inaccurately performed episiotomy can risk in obstetric anal sphincter injuries and hold ground for medical negligence, there are various factors of episiotomy that govern the adequacy and accuracy of the episiotomy and reflect on the incidence of perineal tears. the angle recommeded is between 40-60 degrees. in this study we are comparing the angle of episiotomy between the regular Mayo scissor and the episcissor-60 which is a patented pre fixed scissor and its accuracy in prevention of obstetric tears and perianal injuries.
the secondary objective is to detect the rate of perineal injuries and infection rate and compare between the scissors.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Primigravida multigravida VBAC.
Exclusion Criteria
- •previous obstetric phincter injury assisted vaginal delivery instrumental delivery.
Outcomes
Primary Outcomes
to assess significance of the accurately angled of episiotomy with the use of Episcissor-60 in reduction in obstetric anal sphincter injuries
Time Frame: the assessment is done immediately, after 24 hours
Secondary Outcomes
- to assess accuracy of the angle of episiotomy incision with usage of fixed angle scissor(to assess clinical significance in reducing perineal infection)