Home » Trials » SLCTR/2008/007
Comparative study of restricted episiotomy vs routine episiotomy
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SLCTR Registration Number
SLCTR/2008/007
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Comparative study of restricted episiotomy vs routine episiotomy
Public Title of Trial
Is surgical incision of the perineum of the mother routinely required for the delivery of her first baby?
Disease or Health Condition(s) Studied
Vaginal delivery in primi gravidae
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Can a policy of restricted episiotomy (carrying out an episiotomy only if it is considered to be needed) safely reduce the need for routine episiotomy during delivery of a primi gravidawithout significantly increasing any adverse effects?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
In the study group an episiotomy will be given only if it is considered to be needed in order to prevent vaginal and perineal tears. In the control group all will be given an episiotomy
Inclusion criteria
Primi gravide with singleton pregnancy at 37-42 weeks of gestation and cephalic presentation
Exclusion criteria
Primi gravidae with any medical or obstetric complications
Primary outcome(s)
1.
In the study group the reduction in the propotion of primi gravidae who will have an episiotomy |
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Secondary outcome(s)
1.
Posterior perineal trauma and its severity, anterior vaginal wall tears, perineal pain, haematoma formation, infection, stress urinary incontinence and dysparaeunea |
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Target number/sample size
288
Countries of recruitment
Sri Lanka
Anticipated start date
2008-03-24
Anticipated end date
2009-03-23
Date of first enrollment
2008-11-20
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2008-01-04
Approval number
Not available
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
Telephone: | +94-91-2234801/803 (Extension: 161) |
Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof. Malik Goonewardene
Professor & Head, Department of Obstetrics & Gynaecology
Faculty of Medicine, Galle.
(091)2246878, 2234801/3
(091)2222314
malikg@eureka.lk
Contact Person for Public Queries
Prof. Malik Goonewardene
Professor & Head, Department of Obstetrics & Gynaecology
Faculty of Medicine, Galle.
(091)2246878, 2234801/3
(091)2222314
malikg@eureka.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results