Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees (IAME)

Ain Shams Maternity Hospital

Status and phase: Unknown; Phase 2

Conditions: Obstetric Labor Complications

Treatments: Procedure: episiotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01930721

incision angle of mediolateral

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 2 patient groups

incision angle of 60 degrees

Experimental group

Description:

episiotomy incision angle will be defined as 60 degree as measured before cutting.

Treatment:

Procedure: episiotomy

Procedure: episiotomy

incision angle 40 degree episiotomy

Experimental group

Description:

incision angle of episiotomy will be defined as 40 degree as measured before cutting.

Treatment:

Procedure: episiotomy

Procedure: episiotomy