Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees
IAME
1 other identifier
interventional
330
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 29, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedAugust 29, 2013
August 1, 2013
1.4 years
June 16, 2012
August 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
and fourth degree perineal tears.
DESCRIBING THIRD AND FOURTH degree perieneal tears as regarding repair and post operative pain
intraoperative
Study Arms (2)
incision angle of 60 degrees
EXPERIMENTALepisiotomy incision angle will be defined as 60 degree as measured before cutting.
incision angle 40 degree episiotomy
EXPERIMENTALincision angle of episiotomy will be defined as 40 degree as measured before cutting.
Interventions
incision angle of episiotomy will be 60 degrees.
Eligibility Criteria
You may qualify if:
- Primigravida with singleton pregnancy presenting by vertex.
- Gestational age \> 37 weeks
- No instrumental delivery.
- No fetal distress or any emergency
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams Unversity Hospitals
Cairo, Egypt
Related Publications (1)
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.
PMID: 25056465DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ADEL SH SLAH EL-DIN, MD
LECTURER
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident
Study Record Dates
First Submitted
June 16, 2012
First Posted
August 29, 2013
Study Start
March 1, 2012
Primary Completion
August 1, 2013
Study Completion
September 1, 2013
Last Updated
August 29, 2013
Record last verified: 2013-08