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.: PACTR202404768066197 Date of Approval: 30/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Randomised Trial of early versus routine hospital discharge after planned Caesarean section at the University of Port Harcourt Teaching Hospital
Official scientific title A Randomised Trial of early versus routine hospital discharge after planned Caesarean section at the University of Port Harcourt Teaching Hospital
Brief summary describing the background and objectives of the trial BACKGROUND: Early hospital discharge after caesarean section in selected patients has shown clinical and health system benefits from improved patient satisfaction to reduction in complication and readmission rates and reduced cost. The average hospital stay in the University of Port Harcourt Teaching Hospital following planned caesarean section is 4 days. Patients without complications are often able to ambulate and tolerate orally by the second post-operative day. Preparing them for early discharge, and discharging them after 48 hours may result in increased patient satisfaction and quick recovery without compromising their care. OBJECTIVE: This study seeks to determine if discharge on second post-operative day is satisfactory in patients having uncomplicated caesarean section, and also, to determine if there are adverse outcomes associated with early hospital discharge.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early hospital discharge following elective Caesarean section
Anticipated trial start date 01/03/2023
Actual trial start date 01/04/2023
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date 31/03/2024
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Closed to recruitment,follow-up continuing
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group early hospital discharge group Patients will be discharged 2 days after surgery Participants in the experimental group(early hospital discharge group) will have graded oral intake initiated 6 hours postoperatively. Mobilization will also be encouraged after 6 hours beginning with dangling of legs and sitting on a chair. Urinary catheter will be removed after 12 hours. They will be discharged on the second post-operative day. follow up will be done via phone calls for 2 weeks following discharge. Patients will be seen at first week and second week post operatively before the final six weeks postpartum visit. 100
Control Group routine discharge group patients will be discharged four days after surgery Participants in the control group will have graded oral intake initiated 24 hours postoperatively. Mobilization will be encouraged after 12 hours beginning with dangling of legs and sitting on a chair. Urinary catheter will be removed after 24 hours. They will be discharged on the fourth post-operative day 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Respondents must be between the ages of 20-34 years. Consent to participate in the study Body Mass Index (BMI) <30kg/m2 Booked patients of the antenatal clinic of University of Portharcourt Teaching Hospital Must have attained 37 weeks of gestation Scheduled for elective caesarean section The pregnancies must be uncomplicated, singleton pregnancies. Patients less than 20 years or greater than 35 years Unbooked patients Patients with multiple gestation Co-morbidities - Cardiac disease, immune deficiency, diabetes, anaemia Major degree placenta praevia Pulmonary disorders Intraoperative or postoperative complications Need for blood transfusion Foetal anomaly Post-operative fever Intolerance to liquid diet following surgery Adult: 19 Year-44 Year 20 Year(s) 35 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 27/07/2022 University of Portharcourt Teaching Hospital Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
East West road, Alakahia, Portharcourt Portharcourt 500102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome maternal satisfaction primary outcome will be measured upon discharge of the patient
Secondary Outcome wound infection rate, wound breakdown rate, readmission rate from discharge of the patient, till six weeks post partum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Portharcourt Teaching Hospital East West Road, Alakahia, Portharcourt Portharcourt 500102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Elaine Ajoku Department of Obstetrics and Gynaecology, University of Portharcourt Teaching Hospital Portharcourt 500102 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Elaine Ajoku University of Portharcourt Teaching Hospital Portharcourt 500102 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elaine Ajoku elaineodiaka@yahoo.co.uk +2348058871421 University of Portharcourt Teaching Hospital
City Postal code Country Position/Affiliation
Portharcourt 500102 Nigeria Specialist resident
Role Name Email Phone Street address
Public Enquiries Tamunomie Nyengidiki tammynyengs@yahoo.com +2348037109486 Department of Obstetrics and Gynaecology, University of Portharcourt Teaching Hospital
City Postal code Country Position/Affiliation
Portharcourt 500102 Nigeria Supervising consultant
Role Name Email Phone Street address
Scientific Enquiries Preye Fiebai preye.fiebai@uniport.edu.ng +2348033100450 Department of Obstetrics and Gynaecology, University of Portharcourt Teaching Hospital
City Postal code Country Position/Affiliation
Portharcourt 500102 Nigeria Supervising consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available? Yes, Individual patient data will be made available What specific data will be shared? Sociodemographic characteristics (after de-identification), indications for Caesarean section, patient satisfaction scores, pain scores, maternal and neonatal outcomes. Will additional documents be made available? Additional documents such as patient information leaflet, consent form, study protocol, study pro-forma, patient questionnaire and statistical analysis plan will be made available. When will data be made available? Data will be made available starting from 3 months after publication. Data will be available for 36 months. Who will be able to access data? Data will be available to anyone who wishes to access it What type of analysis will data be made Data will be made available for any purpose. available for? How will data be made Data will be available at the hospital website available? https://upthng.com Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning from three months after publication date and available for 36 months Data will be made available to any person who wishes to access it.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Data will be made available on the hospital website. https://upthng.com 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