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

Obstetric Labor Complications Clinical Trial

— IAME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01930721
• Other study ID #: incision angle of mediolateral
• Status: Recruiting
• Phase: Phase 2
• First received: June 16, 2012
• Last updated: August 28, 2013
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: August 2013
• Source: Ain Shams Maternity Hospital
• Contact: shafik adel, MD
• Email: shafikadel[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstetric Labor Complications

Intervention

Procedure:
• episiotomy
incision angle of episiotomy will be 60 degrees.
• episiotomy
incision angle of episiotomy will be 40 degree before cutting.

Locations

Country	Name	City	State
Egypt	Ain Shams Unversity Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	and fourth degree perineal tears.	DESCRIBING THIRD AND FOURTH degree perieneal tears as regarding repair and post operative pain	intraoperative	Yes