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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202409613935522 Date of Registration: 23/09/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title comparing early versus delayed oral feeds following caesarean section
Official scientific title A randomized control trial comparing early versus delayed oral feeds following caesarean section
Brief summary describing the background and objectives of the trial Background: Caesarean section is one of the most commonly performed surgical procedures in Obstetrics and Gynaecology. There has been a global rise in the rate of Caesarean section. Early postoperative oral feeding has been shown to improve the post operative condition of women with higher maternal satisfaction without any significant difference in postoperative ileus as compared to delayed oral feeding. Enhanced Recovery after Surgery (ERAS) Society recommends resuming a regular diet within 2 hours post-caesarean section and the Society of Obstetric Anaesthesia and Perinatology (SOAP) endorses advancing to regular diet within 4 hours post-caesarean section. These have been adopted in some centres in Nigeria, however, delayed oral feeding is still been practiced in many centres across the country. Objective: The objective of this study is to compare the safety, post-operative morbidities, maternal satisfaction and benefits of early versus delayed oral feeding after uncomplicated caesarean section under spinal anaesthesia.
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 incidence of paralytic ileus
Purpose of the trial Supportive care
Anticipated trial start date 01/09/2024
Actual trial start date 01/09/2024
Anticipated date of last follow up 01/10/2024
Actual Last follow-up date 01/12/2024
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 108
Recruitment status Not yet 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 early feeding group 50mls of clear fluid will be administered 2hrs after caesarean section and then 150mls of tea, pap, or juice will be administered 1hr later if well tolerated, and normal diet taken 4hrs later clear fluids at 2hrs, other fluid feeds 1hr later, then other foods 4hrs post-operatively 50mls of clear fluid will be given at 2hrs after caesarean section, 150mls of fluid diet will be given 1hr later, and normal diets resumed 4hrs post-operatively if well tolerated 54
Control Group delayed feeding group 50mls of clear fluid at 12hrs, 150mls of pap, tea, or juice 1hr later, and normal diet thereafter clear fluid at 12hrs, fluid feeds 1hr later, normal diet thereafter patients will be fed 12hrs after caesarean section with clear fluids, and the 1hr later with pap, juice, or tea, and thereafter resume their normal diets as tolerated 54 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women scheduled to undergo elective caesarean section at term under spinal anaesthesia will be included. Patients who had complicated Caesarean section (post-partum haemorrhage, bowel injury, extensive adhesiolysis, caesarean hysterectomy or myomectomy). Women who had spinal anaesthesia converted to general anaesthesia in the course of surgery will be excluded. Women who do not consent to the study will be excluded Women with medical conditions in pregnancy such as severe pre-eclampsia/eclampsia, diabetes in pregnancy. Adult: 18 Year(s)-44 Year(s) 15 Year(s) 55 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 14/08/2024 Benue State University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Benue State University Teaching Hospital, Makurdi Makurdi 970000 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the incidence of paralytic ileus in both study groups 4hrs for the early feeding group and 13hrs for the delayed feeding group
Secondary Outcome determine the mean ambulation time, total fluid used. Also to determine maternal satisfaction within the two study groups 72hrs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benue State University Teaching Hospital Makurdi Kilometer 4 Gboko Road, Benue State Makurdi 970000 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
out of pocket personal funding Number 10 Atser Iwail Street, Judges Quarters, Makurdi, Benue State Makurdi 970000 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Matthew Sesugh Iorfa Number 10 Atser Iwail Street, Judges Quarters, Makurdi Makurdi 970000 Nigeria Self sponsor
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Matthew Iorfa linkmattew2004@yahoo.com +2348060022952 Number 10 Atser Iwail Street, Judges Quarters, Makurdi
City Postal code Country Position/Affiliation
Makurdi 970000 Nigeria Senior Registrar Department of Obstetrics and Gynaecology Benue State University Teaching Hospital Makurdi
Role Name Email Phone Street address
Public Enquiries Ushakuma Anenga uanenga@yahoo.com +2347031616767 Doctors quarters, Benue State University Teaching Hospital, Makurdi
City Postal code Country Position/Affiliation
Makurdi 970000 Nigeria Fellow West African College of Surgeons
Role Name Email Phone Street address
Scientific Enquiries Terrumun Swende swendetz@yahoo.com +2348065720059 doctors quarters, Benue State University Teaching Hospital, Makurdi
City Postal code Country Position/Affiliation
Makurdi 970000 Nigeria Consultant Obstetrics and Gynaecology Benue State University Teaching Hospital Makurdi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes INDIVIDUAL PARTICIPANT DATA (IPD) SHARING STATEMENT Study Title: Comparison of Early versus Delayed Oral Feeds Following Caesarean Section Principal Investigator: Dr. Matthew Sesugh Iorfa Individual participant data (IPD) collected during this trial, after de-identification, will be made available to researchers upon request. The shared data will include de-identified demographic and clinical data related to postoperative recovery, such as safety, post-operative morbidities, maternal satisfaction, and benefits of early versus delayed oral feeding after caesarean section under spinal anaesthesia. Data will be available for sharing beginning 12 months after the publication of the study results and will remain available for up to 5 years. Access to the data will be granted to qualified researchers affiliated with recognized institutions who submit methodologically sound proposals. Supporting documents such as the study protocol and statistical analysis plan will also be made available upon request. Data will be shared through a secure online data repository, following approval of a request and the signing of a data sharing agreement. Researchers seeking access to the data must submit a request detailing their objectives, the intended use of the data, and an agreement to use the data solely for research purposes as outlined in the data sharing agreement. Requests for data access should be directed to Dr. Iorfa Sesugh at [linkmattew2004@yahoo.com/+2348060022952]. Informed Consent Form,Study Protocol Beginning 12 months after the publication of the study results and will remain available for up to 5 years. Affiliation: Access will be granted to qualified researchers affiliated with recognized institutions. Methodologically Sound Proposal: Researchers must submit a methodologically sound research proposal that outlines their objectives and the intended use of the data. Data Sharing Agreement: Researchers must sign a data sharing agreement, agreeing to use the data solely for research purposes as outlined in the agreement. Timing: The data will be available 12 months after publication and will be accessible for up to 5 years.
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