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

Phase 2

• Conditions: Obstetric Labor Complications
• Interventions: Procedure: episiotomy

• Registration Number: NCT01930721
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-16
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study First Submitted QC: 2013-08-28
• Last Update Submitted: 2013-08-28
• Study First Posted: 2013-08-29
• Last Update Posted: 2013-08-29
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 330

Inclusion Criteria

1. Primigravida with singleton pregnancy presenting by vertex.
2. Gestational age > 37 weeks
3. No instrumental delivery.
4. No fetal distress or any emergency

Exclusion Criteria

1. Women had an episiotomy because of fetal distress and for technical reasons (emergency or episiotomy incised prior to the fetal head crowning the perineum.
2. Inability to understand the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
incision angle of 60 degrees	episiotomy	episiotomy incision angle will be defined as 60 degree as measured before cutting.
incision angle 40 degree episiotomy	episiotomy	incision angle of episiotomy will be defined as 40 degree as measured before cutting.

Primary Outcome Measures

Name	Time	Method
and fourth degree perineal tears.	intraoperative	DESCRIBING THIRD AND FOURTH degree perieneal tears as regarding repair and post operative pain

Trial Locations

Locations (1)

Ain Shams Unversity Hospitals; 🇪🇬 Cairo, Egypt