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.: PACTR202308564052985 Date of Approval: 21/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Optimal duration of bladder catheterization after elective caesarean section to prevent urinary tract morbidity: a randomized controlled trial of 12 versus 24 hours.
Official scientific title Optimal duration of bladder catheterization after elective caesarean section to prevent urinary tract morbidity: a randomized controlled trial of 12 versus 24 hours.
Brief summary describing the background and objectives of the trial The rate of caesarean section has been on the rise worldwide due to its ability to prevent maternal and foetal morbidity and mortality. However, bladder catheterization during caesarean section can result in urinary tract morbidities. The optimal duration before removal of the catheter after caesarean section remains contentious and current practice is rather customary than global best practice guideline. The aim of this trial is to compare the post-operative morbidities associated with either 12-hour or 24-hour duration of bladder catheterization after elective caesarean section. Specific objectives include the prevalence of urine retention, significant bacturiuria, urinary tract infection and the pattern of post-operative recovery between both groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied urine retention and urinary tract infection following catheterization after caesarean section
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/09/2023
Actual trial start date
Anticipated date of last follow up 30/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants)
Recruitment status Active, not 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
Experimental Group G12 This group will have their indwelling urethral catheter removed 12 hours after elective caesarean section. Three months This group will have their indwelling urethral catheter removed 12 hours after elective caesarean section. Thereafter, they will be monitored for urine retention, voiding difficulties, significant bacturiuria, and pattern of post- operative recovery namely time of first voiding, time of ambulation and patient satisfaction. 52
Control Group G24 This group will have their indwelling urethral catheter removed 24 hours after elective caesarean section. Three months This group will have their indwelling urethral catheter removed 24 hours after elective caesarean section. Thereafter, they will be monitored for urine retention, voiding difficulties, significant bacturiuria, and pattern of post-operative recovery namely time of first voiding, time of ambulation and patient satisfaction. 52 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women scheduled for elective caesarean section at term. Elective caesarean section done under spinal anaesthesia Participants who gave consent for the study Participants with no pre-operative clinical evidence of urinary tract infection. Pregnant women whose condition require emergency caesarean section. Elective caesarean section done under general or epidural anaesthesia Pregnant women who did not give consent for the study. Participants who withdrew their consent in the course of the study. Pregnant women with pre-operative clinical evidence of urinary tract infection. Participants with intra-operative bladder injury. Pregnant women with medical condition like cardiac, renal or liver disease. Pregnant women with retroviral disease. Adult: 19 Year-44 Year 19 Year(s) 44 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 05/04/2023 Health Research Ethics committee
Ethics Committee Address
Street address City Postal code Country
Lagos-Benin Express Road, Ugbowo Benin city Benin city Edo State Nigeria PMB1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Urine retention which is the inability of the patient to void spontaneously within 6-hours of the removal of urethral catheter following elective caesarean section despite palpable full bladder. six hours
Primary Outcome Significant bacturiuria defined as the presence of greater than or equal to 100,000 colony forming units of pathogenic organisms per millilitre of mid-stream urine sample collected from the subjects pre-operatively and day-2 post-operatively following urine culture. 48 hours after surgery
Secondary Outcome Time to ambulate defined as the first time of getting off hospital bed and taking a walk, with or without assistance after completion of skin closure. 12 hours to 24 hours
Primary Outcome Symptomatic urinary tract infection defined as the presence of significant bacturiuria with at least one of the following signs and symptom- fever, urinary frequency, urgency, dysuria, suprapubic tenderness or renal angle pain or tenderness. Within 10 days post-operatively
Secondary Outcome Length of hospital stay defined as the period starting from the complete closure of skin incision to hospital discharge. 3 to 7 days
Secondary Outcome Patient satisfaction defined as participants preference to have same timing of urethral catheter removal during a repeat caesarean section. Also participants who agree to recommend the same timing of urethral catheter removal in index delivery to a friend or relative. 12 or 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital Benin city Edo state Nigeria Ugbowo road Benin city PMB1111 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Loretta Nnakwe Department of Obstetrics and Gynaecology, University of Benin Teaching Hospital Benin City PMB1111 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Loretta Nnakwe Department of Obstetrics and Gynaecology, University of Benin Teaching Hospital Benin City Edo State PMB1111 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Loretta Nnakwe renechi.rn@gmail.com +2348177082022 Department of Obstetrics and Gynaecology, University of Benin Teaching Hospital
City Postal code Country Position/Affiliation
Benin city PMB1111 Nigeria Senior Registrar Department of Obstetrics and Gynaecology University of Benin Teaching Hospital.
Role Name Email Phone Street address
Principal Investigator Loretta Nnakwe renechi.rn@gmail.com +2348177082022 Department of Obstetrics and Gynaecology, University of Benin Teaching Hospital
City Postal code Country Position/Affiliation
Benin city PMB1111 Nigeria Senior Registrar Department of Obstetrics and Gynaecology University of Benin Teaching Hospital.
Role Name Email Phone Street address
Public Enquiries Loretta Nnakwe renechi.rn@gmail.com +2348177082022 Department of Obstetrics and Gynaecology, University of Benin Teaching Hospital
City Postal code Country Position/Affiliation
Benin city PMB1111 Nigeria Senior Registrar Department of Obstetrics and Gynaecology University of Benin Teaching Hospital.
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 will be shared, after deidentification (text, tables, figures, and appendices) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide a methodologically sound proposal. Access and data can be requested after data access agreement at third party site info@ubth.org
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