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.: PACTR201912777385309 Date of Approval: 17/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Infection of the Water Way via Catheter
Official scientific title Catheter Associated Urinary Tract Infection: 12 Hours versus 24 Hours Urinary Catheter Removal Following Uncomplicated Cesarean Section in Ekiti State
Brief summary describing the background and objectives of the trial Catheter associated urinary tract infection (CA-UTI) is the commonest cause of nosocomial infection. It accounts for up to 10-70% of all nosocomial infections. Minimizing the length of stay of indwelling urinary catheter is a major way that have been published in reducing rate of infection . How long is acceptable has been a major debate in the literature? What benefit does short urinary catheterization tends to offer apart from reduction in infection rate? How appreciable will catheterization affect cost of hospital stay? Does the length of catheterization determines the probable length of immobilization. AIM: To compare the incidence of significant bacteriuria defined as ≥100,000 bacteria of the same colony per millilitre of urine in a sample of midstream urine collected 72 hours postoperatively in patients with 12hours versus 24hour removal of urinary catheter following uncomplicated caesarean section. METCatheter associated urinary tract infection (CA-UTI) is the commonest cause of nosocomial infection. It accounts for up to 10-70% of all nosocomial infections. Minimizing the length of stay of indwelling urinary catheter is a major way that have been published in reducing rate of infection .
Type of trial RCT
Acronym (If the trial has an acronym then please provide) U.T.I
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied URINARY TRACT INFECTIONS
Purpose of the trial Prevention
Anticipated trial start date 24/01/2019
Actual trial start date 03/04/2019
Anticipated date of last follow up 15/02/2019
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants) 130
Recruitment status Completed
Publication URL https://pactr.samrc.ac.za/Researcher/TrialRegister.aspx?TrialID=5861
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 12HOURS PASSAGE OF URINARY CATHETER FOR 12 HOURS Randomization will start from block one till it gets to the last block.All parturients will be encouraged to sit out of bed by 8hours after the surgery irrespective of presence or absence of the catheter and ambulate after 10hours post-surgery33. In all participants, a Foley’s urethral catheter (French size16) will be inserted under aseptic condition with the help of an assistance and this is done on the operating table. The procedure for the passage of urinary catheter is aseptic.The procedure of insertion will be explained to the patient.The materials needed include Foley catheter,water for injection,savlon, urine bag, 5mls syringe and soaked cotton wool. The labia is parted with the non dominant hand, the right labia is swabbed down and the second swab is used to clean the left labia while the third swab is used to swab down the central part of the vulva.The catheter under aseptic technique is gently inserted into the bladder through urethral orifice.About 5mls of sterile water is used to inflate the balloon while the tube is connected to a closed system called the urine-bag.Pre-operative urine sample is collected for microscopy culture and sensitivity to exclude patients with asymptomatic bacteriuria. The specimens will be immediately sent to the laboratory for immediate processing.Urine microscopy will be performed on uncentrifuged urine specimen to detect the presence of leukocytes, erythrocytes and other cells. A sterile calibrated wire loop will be used to deliver a loopful (0.01ml) of urine onto each of Blood, MacConkey plates and incubatedaerobically at 37⁰C for 18 - 24 hours30. Significant growth of ≥100 bacteria/ml of urinewill be interpreted as at least one colony of bacterial organism per plate.Pure colonies of isolated organism on the culture plates will be biochemically characterized to identify the different species of organisms isolated30. Antibiotic susceptibility testing (ATS) will be done using modified Kirby-Bauer disk diffusion metho 65
Control Group 24HOURS 3 MONTHS Randomization will start from block one till it gets to the last block.All parturients will be encouraged to sit out of bed by 8hours after the surgery irrespective of presence or absence of the catheter and ambulate after 10hours post-surgery33. In all participants, a Foley’s urethral catheter (French size16) will be inserted under aseptic condition with the help of an assistance and this is done on the operating table. The procedure for the passage of urinary catheter is aseptic.The procedure of insertion will be explained to the patient.The materials needed include Foley catheter,water for injection,savlon, urine bag, 5mls syringe and soaked cotton wool. The labia is parted with the non dominant hand, the right labia is swabbed down and the second swab is used to clean the left labia while the third swab is used to swab down the central part of the vulva.The catheter under aseptic technique is gently inserted into the bladder through urethral orifice.About 5mls of sterile water is used to inflate the balloon while the tube is connected to a closed system called the urine-bag.Pre-operative urine sample is collected for microscopy culture and sensitivity to exclude patients with asymptomatic bacteriuria. The specimens will be immediately sent to the laboratory for immediate processing.Urine microscopy will be performed on uncentrifuged urine specimen to detect the presence of leukocytes, erythrocytes and other cells. A sterile calibrated wire loop will be used to deliver a loopful (0.01ml) of urine onto each of Blood, MacConkey plates and incubatedaerobically at 37⁰C for 18 - 24 hours30. Significant growth of ≥100 bacteria/ml of urinewill be interpreted as at least one colony of bacterial organism per plate.Pure colonies of isolated organism on the culture plates will be biochemically characterized to identify the different species of organisms isolated30. Antibiotic susceptibility testing (ATS) will be done using modified Kirby-Bauer disk diffusion metho 65 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting pregnant women that will undergo uncomplicated caesarean sections irrespective of time and indication 1.eclampsia, 2. obstructed labour 3. urinary tract infection in pregnancy by (M.C.S) 4. unconscious patients 5.Non consenting patient. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 11/12/2018 EKITI STATE UNIVERSITY TEACHING HOSPITAL ADO
Ethics Committee Address
Street address City Postal code Country
ADEBAYO ado 3605355 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome INCIDENCE OF BACTERIURIA AT THE END OF CATHETER REMOVAL
Secondary Outcome URINARY RETENTION AND SATISFACTION LEVEL POST CATHETER REMOVAL
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
EKSUTH ADEBAYO STREET ADO Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adeyanju Benedict Tolulope POLY ROAD 9 OFF BOVA FILLING STATION ADO Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ADEYANJU BENEDICT TOLULOPE RD 9 OFF BOVA FILLING STATION harmony street ado ADO Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
DR AWOLEKE JACOB EKITI STATE UNIVERSITY TEACHING HOSPITAL ADO ADO Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ADEYANJU TOLULOPE BENEDICT adeyanjubti@yahoo.com +2348038476366 rd 9 off Bova filling station poly rd ado
City Postal code Country Position/Affiliation
Ado Nigeria senior registrar
Role Name Email Phone Street address
Scientific Enquiries peter ADULOJU peter.aduloju@yahoo.com +2348033900908 poly road ado
City Postal code Country Position/Affiliation
ado Nigeria CONSULTANT
Role Name Email Phone Street address
Public Enquiries olumuyiwa AWOLEKE bisijacob@yahoo.co.uk +2348063289272 Nova junction ADO EKITI
City Postal code Country Position/Affiliation
ADO Nigeria CONSULTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes sharing sociodemographic data and other relevant data Statistical Analysis Plan,Study Protocol 3monthly open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://pactr.samrc.ac.za/Researcher/TrialRegister.aspx?TrialID=5861 No
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