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.: PACTR202307905177842 Date of Approval: 27/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Problems associated with urethral catheterization after caesarean section at Federal Medical Centre, Abeokuta, Ogun State.
Official scientific title Duration of urethral catheterization and associated morbidities at Federal Medical Centre Abeokuta : A randomized control trial.
Brief summary describing the background and objectives of the trial Urethral catheterization is routinely done during and after caesarean section (CS), due to the expected benefits. Intraoperatively, it is used to improve visualization and minimize intraoperative bladder injury, by maintaining continuous bladder drainage. In the postoperative period, it used for urinary output assessment, prevention of urine retention which may lead to primary postpartum haemorrhage, and for the comfort of the patient in the immediate post-operative period. This age-long procedure has however been noted to be customary rather than evidence based; hence there is no clear recommendation on the duration of catheterization after CS, which varies amongst obstetricians. Furthermore, due to its invasive nature, the procedure is a potential threat to patients’ safety, potentially contributing to maternal morbidity following CS. The aim of this study is to establish the association between the duration of urethral catheterization and post-caesarean section morbidity at Federal Medical Centre, Abeokuta.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) UCAMPS
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Catheter-associated complications of the urinary tract following caesarean section
Purpose of the trial Prevention
Anticipated trial start date 15/05/2023
Actual trial start date
Anticipated date of last follow up 15/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants)
Recruitment status Recruiting
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 24 hours of urethral catheterization following caesarean section 24 hours Urethral catheterization of patients at the beginning of caesarean section and removal of catheter 24 hours after completion of caesarean section 55 Active-Treatment of Control Group
Experimental Group 6 hours of urethral catheterization following caesarean section 6 hours Insertion of urethral catheter at the beginning of caesarean section, and removal of the catheter 6 hours after the completon of caesarean section 55
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women admitted for elective CS under spinal anaesthesia Women who gave a written informed consent Pre-existing urinary tract infection Women undergoing emergency CS Women with co-existing medical conditions (preeclampsia, eclampsia, sickle cell disease, diabetic mellitus), or any other conditions requiring postoperative monitoring of urinary output Women who sustain iatrogenic bladder injury Women who do not give consent to the study Adult: 19 Year-44 Year 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 16/09/2022 Ethical Committee Federal Medical Centre Abeokuta
Ethics Committee Address
Street address City Postal code Country
Olabisi Onabanjo Way, Idi-Aba, Abeokuta, Ogun State, Nigeria Abeokuta 110222 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome i. To determine the incidence of catheter-associated asymptomatic bacteriuria 48 hours after removal of urethral catheter
Primary Outcome To determine the incidence of catheter-associated urinary tract infection 48 hours after removal of urethral catheter
Primary Outcome i. To determine the incidence of non-infectious catheter associated complications following early and late catheter removal post CS at FMC Abeokuta During insertion of urethral catheter, while urethral catheter is in-situ, after removal of urethral catheter
Secondary Outcome To determine the incidence of urinary retention After removal of urethral catheter
Secondary Outcome To determine the causative microbiological agents and the antibiotic sensitivity pattern 48 hours after removal of urethral catheter
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Abeokuta Olabisi Onabanjo Way, Idi-Aba Abeokuta 110222 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self 1, Moshalasi Street, Off FUNAAB Road, Camp, Abeokuta Abeokuta 110119 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sariyu Olonade 1. Moshalasi Street, off FUNAAB Road, Camp, Abeokuta Abeokuta 110119 Nigeria Self
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sariyu Olonade ibiyemi4good@gmail.com +2347038975767 1, Moshalasi Street, off FUNAAB Road, Camp, Abeokuta
City Postal code Country Position/Affiliation
Abeokuta 110119 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Michael Oluwafemi oyedelemichael@gmail.com +2348104920800 Idi-Aba, Abeokuta
City Postal code Country Position/Affiliation
Abeokuta 110222 Nigeria Junior Registrar
Role Name Email Phone Street address
Scientific Enquiries Taofeek Ogunfunmilayo ogunfunmilayo@yahoo.com +2348034082140 Ewang Estate, Idi-Aba, Abeokuta
City Postal code Country Position/Affiliation
Abeokuta 110222 Nigeria Consultant Obstetrician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data generated from this study may be provided to qualified researchers with interest in urinary tract infection in obstetric patients or morbidities associated with urethral catheterization. Such shared data shall be coded, and individual participant information shall not be disclosed. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with such requesting party Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted at least 9 months after article publication and the data will be made accessible for up to 24 months. Extensions to this will be considered on individual basis Qualified researchers engaging in independent scientific reseach can request for access to trial IPD, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
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