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.: PACTR202303472142946 Date of Approval: 29/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Early versus late post-caesarean section discharge among paturients in Enugu: A randomized controlled trial.
Official scientific title Early versus late post-caesarean section discharge among paturients in Enugu: A randomized controlled trial.
Brief summary describing the background and objectives of the trial The concept of early discharge after Caesarean delivery is not routinely practiced in many centers in spite of its prospects of reducing hospital charges, minimizing puerperal complications, enhancing early reunification with family members and optimizing overall patient’s satisfaction. A postoperative discharge schedule could have major implications on the management of post-Caesarean section mothers.This study is aimed at comparing maternal satisfaction, cost of treatment and pueperal complications between paturients that had early versus late post-Caesarean section discharge in Enugu, Nigeria.
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 General Obstetrics
Purpose of the trial Psychosocial
Anticipated trial start date 20/03/2023
Actual trial start date 20/03/2023
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date 29/09/2023
Anticipated target sample size (number of participants) 206
Actual target sample size (number of participants)
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 Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Early discharge group The parturients who will have elective caesarean section will be discharged from the hospital after 72 hours postoperatively.Traditionally , the Obstetrics and Gynaecology Department of UNTH,Enugu protocol stipulates that uneventful post-caesarean section paturients should be discharged from the hospital between 5 and 7 days postoperatively. So we want to determine if early(72 hours) postoperative discharge of such patients will be feasible hence this group will be the interventional group. 3 days The parturients who will have elective caesarean section will be discharged from the hospital after 72 hours postoperatively 103
Control Group Late discharge group The parturients who will have elective caesarean section will be discharged from the hospital after 120 hours postoperatively. This is in the departmental protocol of Obstetrics and Gynaecology ,UNTH,Enugu in which every uneventful post-caesarean section patient is discharged from the hospital between 5 and 7 days postoperatively. 5 days The parturients who will have elective caesarean section will be discharged from the hospital after 120 hours postoperatively 103 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.The patient will be booked and will be attending antenatal care at either UNTH or ESUTH. 2.The patient will be booked for an elective Caesarean delivery and has been reviewed by the anesthetist and certified fit for surgery. 3.Patient who has given written consent. 1.Patient with co-morbidities that may require multidisciplinary management such as sickle cell anaemia, asthma, diabetes mellitus, and cardiac disease in pregnancy. 2.Patient who is not fit for discharge. 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 26/12/2022 Health Research Ethics Committee University of Nigeria Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Ituku-Ozalla Enugu 40001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Overall patient’s satisfaction, using structured questionnaire containing 46 questions and will be scored between 46 and 230 points. The cut-off point will be determined by the mean score. 6 weeks
Secondary Outcome 1.Mean cost of hospital bills. 2.Proportion of participants who developed clinical wound infection: swelling, induration of wound edges, seropurulent/purulent discharge or wound dehiscence, fever greater or equal to 380C or differential warmth. 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Ituku-Ozalla Enugu 40001 Nigeria
ESUT Teaching Hospital Park Lane Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Omeje Innocent Ituku-Ozalla Enugu 40001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Innocent Omeje UNTH Enugu 40001 Nigeria Individual
Secondary Sponsor Dr. Leonard Ajah UNTH Enugu 40001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Innocent Omeje innoomeje@yahoo.com +2348062846655 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Leonard Ajah leonard.ajah@unn.edu.ng +2348033920789 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Reader
Role Name Email Phone Street address
Public Enquiries Cyril Dim dyme72@yahoo.com +2348033341960 Ituku-Ozalla
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: Yes Data obtained through this study may be provided to qualified researchers with academic interest in obstetrics and Gynaecology. Data or samples shared will be coded with the personal identification excluded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 2 years. Extension can be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a study protocol,Statistical Analysis Plan ,informed consent form and clinical study report. For more information or to submit a request, please contact pactradmin@mrc.ac.za.
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