Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees

Study Overview
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Brief Summary
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The angle at which an episiotomy can be made is a continuous variable. If the investigators consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90 degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees.

Detailed Description
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Episiotomy is a surgical incision to the perineum in order to enlarge the vaginal orifice during the second stage of labor. Although seven types of episiotomy have been described in the literature , the most frequently performed types are the mediolateral and median episiotomies, with the former being the most common one. Despite being a common obstetric practice, the exact definition of a mediolateral episiotomy is often unclear. Several studies and reports, however, stated that a significant proportion of the so-claimed mediolateral episiotomy were not actually mediolateral. The current trial compares two angles of mediolateral episiotomy , regarding the risk of third- and fourth-degree perineal tearing, episiotomy-related pain and dyspareunia in primiparous women at a large tertiary maternity center, namely Ain Shams University Maternity Hospital, Cairo, Egypt.

Official Title
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Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees

Conditions
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Obstetric Labor Complications

Intervention / Treatment
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* Procedure: episiotomy
* Procedure: episiotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primigravida with singleton pregnancy presenting by vertex. Gestational age > 37 weeks No instrumental delivery. No fetal distress or any emergency Exclusion Criteria: Women had an episiotomy because of fetal distress and for technical reasons (emergency or episiotomy incised prior to the fetal head crowning the perineum. Inability to understand the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: incision angle of 60 degrees<br>episiotomy incision angle will be defined as 60 degree as measured before cutting. | Procedure: episiotomy<br>* incision angle of episiotomy will be 40 degree before cutting.<br>|
| Experimental: incision angle 40 degree episiotomy<br>incision angle of episiotomy will be defined as 40 degree as measured before cutting. | Procedure: episiotomy<br>* incision angle of episiotomy will be 60 degrees.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| and fourth degree perineal tears. | DESCRIBING THIRD AND FOURTH degree perieneal tears as regarding repair and post operative pain | intraoperative |