- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02911779
The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Holon, Israel, 58100
- Wolfson Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women during labor above 37 weeks, Occiput presentation
Exclusion Criteria:
- cesarean section, vacuum or forceps deliver, breech deliver, below 37 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: change of medilateral angle line
change of medilateral angle line during crowning of the head
|
change of medilateral angle line during crowning of the head
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of medilateral angle line during crowning of the head
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0181-11-WOMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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