Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201405000819843 Date of Approval: 04/05/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Perineal repair trial
Official scientific title Perineal repair with single suture single knot versus multiple suture multiple knot technique: a randomised controlled trial.
Brief summary describing the background and objectives of the trial Episiotomy is the most common surgical incision made on any delivery suite, and pain following an episiotomy remains the most frequent postpartum complaint. The primary goal of an episiotomy or a second-degree perineal tear repair is to restore the normal anatomy with good function, and this is done with minimal complications such as pain and dyspareunia. This desired outcome is largely dependent on the technique of repair. The aim of this study is to test the hypothesis that there is no difference between the mean pain scores of women whose second degree perineal tear were repaired by a single suture single knot technique and those repaired by a multiple knot technique.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetric perineal trauma,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 04/06/2014
Actual trial start date 01/07/2014
Anticipated date of last follow up 31/03/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 264
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL http://link.springer.com/article/10.1007%2Fs00404-016-4101-2
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised The simple allocation sequence was computer generated Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group single suture single knot technique of repair single suture single knot technique of repai 132 Active-Treatment of Control Group
Experimental Group Single suture single knot technique Not applicable Not applicable Perineal repair 132 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
spontaneous vaginal birth gestational age of 37 weeks and above, episiotomy or second degree perineal tear, repair performed by one of the trained doctors nulliparity. declined to participate, instrumental vaginal delivery, extensive perineal trauma, delivered of still born baby or baby with severe congenital anomalies a history of previous perineal surgery, hematological disorder, HIV, hepatitis b virus infection, sickle cell disease, and severe perineal warts 16 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/04/2014 Ethics and Research Committe
Ethics Committee Address
Street address City Postal code Country
University of Benin Teaching Hospital, Ugbowo, Road, Benin City PMB 111, Benin City Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome was perineal pain experienced on walking or sitting 10 days post delivery
Secondary Outcome the use of analgesia, the need for suture removal, wound dehiscence, urinary and bowel problems, sexual difficulties, patient satisfaction with cosmetic appearance. 10 days and 3 months post delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching hospital, Ugbowo Road Benin City Edo State Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
None
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mr Dan Selo-Ojeme Barnet and Chase farm Hospital, The Ridgeway Enfield EN2 8JL United Kingdom Charities/Societies/Foundation
Secondary Sponsor Dr Chukweunwendu Anthony Okonkwo University of Benin Teaching Hospital, Ugbowo Road Benin City Edo State Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dan Selo-Ojeme The Ridgeway Enfield EN2 8JL United Kingdom
Dr Chukweunwendu Anthony Okonkwo University of Benin Teaching Hospital, Ugbowo Road Benin City Edo State Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dan Selo-Ojeme dseloojeme@aol.com +448451114000 The Ridgeway
City Postal code Country Position/Affiliation
Enfield EN2 8JL United Kingdom Consultant Obstetrician
Role Name Email Phone Street address
Public Enquiries Dan Selo-Ojeme dseloojeme@aol.com +448451114000 The Ridgeway
City Postal code Country Position/Affiliation
Enfield EN2 8JL United Kingdom Consultant Obstetrician
Role Name Email Phone Street address
Scientific Enquiries Chukweunwendu Anthony Okonkwo drcokonkwo@yahoo.com +2348060613220 University of Benin Teaching Hospital
City Postal code Country Position/Affiliation
Benin City Edo State Nigeria Consultant Obstetrician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information