NCT02911779

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

September 18, 2016

Last Update Submit

September 21, 2016

Conditions

Labor, ObstetricEpisiotomy

Outcome Measures

Primary Outcomes (1)

  • Change of medilateral angle line during crowning of the head

    18 months

Study Arms (1)

change of medilateral angle line

OTHER

change of medilateral angle line during crowning of the head

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

Interventions

change of medilateral angle line during crowning of the headPROCEDURE

change of medilateral angle line during crowning of the head

change of medilateral angle line

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women during labor above 37 weeks, Occiput presentation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Medical Center

Holon, 58100, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor OBGYN

Study Record Dates

First Submitted

September 18, 2016

First Posted

September 22, 2016

Study Start

February 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

September 22, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)