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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
malka amen, Ain Shams Maternity Hospital Identifier:
First received: June 16, 2012
Last updated: August 28, 2013
Last verified: August 2013
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.

Condition Intervention Phase
Obstetric Labor Complications
Procedure: episiotomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees

Further study details as provided by Ain Shams Maternity Hospital:

Primary Outcome Measures:
  • and fourth degree perineal tears. [ Time Frame: intraoperative ]
    DESCRIBING THIRD AND FOURTH degree perieneal tears as regarding repair and post operative pain

Estimated Enrollment: 330
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.

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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01930721

Contact: shafik adel, MD

Ain Shams Unversity Hospitals Recruiting
Cairo, Egypt
Contact: adel shafik, lecturer    01005223586   
Principal Investigator: malka ameen         
Sponsors and Collaborators
Ain Shams Maternity Hospital
Principal Investigator: ADEL SH SLAH EL-DIN, MD LECTURER
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: malka amen, resident, Ain Shams Maternity Hospital Identifier: NCT01930721     History of Changes
Other Study ID Numbers: incision angle of mediolateral
Study First Received: June 16, 2012
Last Updated: August 28, 2013

Additional relevant MeSH terms:
Obstetric Labor Complications
Pregnancy Complications processed this record on May 25, 2017