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

August 28, 2013 updated by: malka amen, Ain Shams Maternity Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams Unversity Hospitals
        • Contact:
        • Principal Investigator:
          • malka ameen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: ADEL SH SLAH EL-DIN, MD, Lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

June 16, 2012

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

August 29, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • incision angle of mediolateral

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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