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.: PACTR201311000610495 Date of Approval: 12/08/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ANTIBIOTIC PROPHYLAXIS IN PATIENTS UNDERGOING CAESAREAN SECTION IN MULAGO HOSPITAL UGANDA: EFFECT OF TIME OF PROPHYLAXIS A SINGLE BLINDED RCT
Official scientific title ANTIMICROBIAL PROPHYLAXIS IN CAESAREAN SECTION IN A UGANDAN HOSPITAL: A RANDOMISED CLINICAL TRIAL EVALUATING EFFECT OF TIME OF ADMINISTRATION ON INCIDENCE OF POSTOPERATIVE INFECTION
Brief summary describing the background and objectives of the trial Background: Prophylactic antibiotic administration is used to prevent post surgical infection after caesarean section. There is observed differences at the timing of administration one group gives before skin incision another after skin incision. Objective: To compare the effect of administration of prophylactic antibiotic within one hour before skin incision and administration after skin incision on incidence of post operative infection in caesarean section patients in Mulago Referal Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Prophylaxis in caesarean section,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/09/2013
Actual trial start date 15/09/2013
Anticipated date of last follow up 01/03/2014
Actual Last follow-up date 15/03/2014
Anticipated target sample size (number of participants) 464
Actual target sample size (number of participants) 464
Recruitment status Completed
Publication URL
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomi, 4 blocks size 116 sealed envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group within 1 hour before skin incision ceftriaxone 2g, once once before skin incision 232
Control Group after skin incision ceftriaxone 2g once standard protocol 232
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Scheduled for emergency caesarean section Accepted and signed consent to be in study Evidence of current infection Already on antibiotics or received within 1 week Allergy to cephalosporins 16 Year(s) 45 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 02/09/2013 School of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Makerere University College of Health Sciences Kampala Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome presence or absence of infection Post op day 1 Post op Day 2 Post op day 3 post op day 10
Secondary Outcome neonatal outcome post op day 1 Post op day 2 Post op day 3 Post op day 10
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mulago Referal Hospital Upper Mulago Hill road Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Kampala Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lomangisi Diana Dlamini Kampala Uganda Funding Agency
COLLABORATORS
Name Street address City Postal code Country
none
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lomangisi Diana Dlamini ngisi2@yahoo.com +256 756072584 Makerere University College of Health Sciences
City Postal code Country Position/Affiliation
Kampala Uganda Senior House Officer
Role Name Email Phone Street address
Public Enquiries Aida Nakawunde rresearch9@gmail.com +256 41 533 541 Makerere University School of Medicine
City Postal code Country Position/Affiliation
Kampala Uganda Secretary
Role Name Email Phone Street address
Scientific Enquiries Arthur Kwizera kwizera.arthur@gmail.com +256 772897171 Makerere University College of Health Sciences
City Postal code Country Position/Affiliation
Kampala Uganda Lecturer
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
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information