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.: PACTR202105874744483 Date of Approval: 31/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Eight-hour versus 24-hour Urethral Catheter Removal Following Elective Caesarean Section for Reducing Bacteriuria: A Randomized Controlled Clinical Trial
Official scientific title Eight-hour versus 24-hour Urethral Catheter Removal Following Elective Caesarean Section for Reducing Bacteriuria: A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Objectives: To compare the rate of bacteriuria and rate of urine retention , mean time at first voiding, mean time until ambulation post elective caesarean section following 8-hour and 24-hour urethral catheter removal. Methods: A randomized controlled trial of eligible parturient that undergone elective caesarean section under spinal anaesthesia between 20th of March 2019 and concluded within a period of twenty seven months and ten days on June 30, 2021 were randomly assigned (1:1 ratio) to either 8-hour (8 hour urethral catheter removal post caesarean delivery) or 24-hour (8 hour urethral catheter removal post caesarean delivery) was done. The primary outcome measures included rate of significant bacteriuria and rate of urine retention post-operative urethral catheter removal. Intention-to-treat principle was applied to analysis
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IgbodikeEP Trial
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 20/03/2019
Actual trial start date 20/03/2019
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group THR 24hour post caesarean section removal of urethral catheter 150 Active-Treatment of Control Group
Experimental Group EHR 8 hour post caesarean section removal of urethral catheter 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. Emergency Caesarean deliveries. b. Elective Caesarean delivery with intra operative urinary bladder injury. c. Failed spinal anaesthesia that may warrant conversion to general anaesthesia. d. Pregnant women whose pre-operative mid-stream clean catch urine microscopy and culture yielded significant bacteria growth. a. Emergency Caesarean deliveries. b. Elective Caesarean delivery with intra operative urinary bladder injury. c. Failed spinal anaesthesia that may warrant conversion to general anaesthesia. d. Pregnant women whose pre-operative mid-stream clean catch urine microscopy and culture yielded significant bacteria growth. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 49 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
No 25/05/2021 Ethics Research committee Obafemi awolowo university teaching hospital complex ile ife
Ethics Committee Address
Street address City Postal code Country
ife central osun state ile ife 220001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome rate of bacteriuria and rate of urine retention ie need for recatheterization post urethral catheter removal
Secondary Outcome time at first voiding , time until ambulation, duration of hospital stay , satisfaction rate post caesarean section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Departments of Obstetric Gynecology Perinatology and Medical Microbiology and Parasitology Obafemi Awolowo University Teaching Hospital Complex Ile Ife ife central ile ife osun state 220001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
igbodike emeka phlip 37 Furo Ezimora close off Adebimpe drive Lekki Phase 1 lekki 5001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor igbodike Emeka Philip Ife Central Ile Ife 220001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Igbodike Emeka Philip Ife Central Lekki Phase 1 5001 Nigeria
Awowole Ibraheem ife central Ile Ife 22001 Nigeria
olapade B ife central ile ife 220001 Nigeria
SO Olateju ife central ile ife 220001 Nigeria
GU Eleje nnewi north nnewi 5001 Nigeria
ajenifuja KO ife central ile ife 220001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emeka Igbodike dr.igbodike@gmail.com +2348037563976 37 Furo Ezimora Street , off Dr Adebimpe Drive Lekki Phase 1
City Postal code Country Position/Affiliation
Lekki 105102 Nigeria Consultant Obstetrician and Gynaecologist Obafemi Awolowo University Teaching Hospital Complex Ile Ife Osun State
Role Name Email Phone Street address
Scientific Enquiries George Eleje gu.eleje@unizik.edu.ng +2348068117444 Nnamdi Azikiwe University Teaching Hospital Nnewi campus
City Postal code Country Position/Affiliation
nnewi 5025 Nigeria Associate Professor Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi campus
Role Name Email Phone Street address
Public Enquiries Ibraheem Awowole drawo2001@yahoo.com +2348033767719 Obafemi Awolowo University Teaching Hospital Complex Ife Central
City Postal code Country Position/Affiliation
ile ife 220001 Nigeria Consultant Obstetrician and Gynaecologist Obafemi Awolowo University Teaching Hospital Complex Ife Central
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article after deidentification text tables figures and appendices Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately following publication. No end date Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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