The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor

Episiotomy Clinical Trial

Official title:

The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911779
• Other study ID #: 0181-11-WOMC
• Status: Completed
• Phase: N/A
• First received: September 18, 2016
• Last updated: September 21, 2016
• Start date: February 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2016
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

In order to determine the optimal angle to perform an episiotomy, the investigators assessed the angle of marked episiotomy lines at the first stage of labor and at the time of crowning of the head.

Incision lines for mediolateral episiotomy were pre-marked on the perineal skin at 30°, 45°, and 60° angles from the midline, at the first stage of labor, in women with singleton pregnancies. The angles of the marked lines were measured again at crowning of the head. Mediolateral episiotomy was performed only for obstetric indications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• women during labor above 37 weeks, Occiput presentation

Exclusion Criteria:

• cesarean section, vacuum or forceps deliver, breech deliver, below 37 weeks

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Episiotomy
• Labor, Obstetric

Intervention

Procedure:
• change of medilateral angle line during crowning of the head
change of medilateral angle line during crowning of the head

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of medilateral angle line during crowning of the head		18 months	No