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

16 May 2008

The date of last modification

Mar 03, 2019


Trial Status



Application Summary


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


Trial Details


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

[]

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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Dept. of Obstetrics & Gynaecology

Faculty of Medicine, Galle
091)2246878, 2234801/3
(091)2222314

Secondary study sponsor (If any)

None





Trial Completion details


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