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

Primary Purpose

Obstetric Labor Complications

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
episiotomy
episiotomy
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Labor Complications

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Ain Shams Unversity HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

incision angle of 60 degrees

incision angle 40 degree episiotomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 16, 2012
Last Updated
August 28, 2013
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01930721
Brief Title
Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees
Acronym
IAME
Official Title
Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
incision angle of 60 degrees
Arm Type
Experimental
Arm Description
episiotomy incision angle will be defined as 60 degree as measured before cutting.
Arm Title
incision angle 40 degree episiotomy
Arm Type
Experimental
Arm Description
incision angle of episiotomy will be defined as 40 degree as measured before cutting.
Intervention Type
Procedure
Intervention Name(s)
episiotomy
Intervention Description
incision angle of episiotomy will be 60 degrees.
Intervention Type
Procedure
Intervention Name(s)
episiotomy
Intervention Description
incision angle of episiotomy will be 40 degree before cutting.
Primary Outcome Measure Information:
Title
and fourth degree perineal tears.
Description
DESCRIBING THIRD AND FOURTH degree perieneal tears as regarding repair and post operative pain
Time Frame
intraoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shafik adel, MD
Email
shafikadel@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ADEL SH SLAH EL-DIN, MD
Organizational Affiliation
LECTURER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams Unversity Hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
adel shafik, lecturer
Phone
01005223586
Email
shafikadel@yahoo.com
First Name & Middle Initial & Last Name & Degree
malka ameen

12. IPD Sharing Statement

Citations:
PubMed Identifier
25056465
Citation
El-Din AS, Kamal MM, Amin MA. Comparison between two incision angles of mediolateral episiotomy in primiparous women: a randomized controlled trial. J Obstet Gynaecol Res. 2014 Jul;40(7):1877-82. doi: 10.1111/jog.12432.
Results Reference
derived

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

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