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.: PACTR202303749998721 Date of Approval: 08/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of immediate and early oral feeding regimens following uncomplicated caesarean sections in Ile-Ife, Nigeria: a randomized controlled trial
Official scientific title Comparison of immediate and early oral feeding regimens following uncomplicated caesarean sections in Ile-Ife, Nigeria: a randomized controlled trial
Brief summary describing the background and objectives of the trial Background: Current evidence has dispelled the traditional practice of withholding oral nutrition until return of bowel function following uncomplicated caesarean section. Early initiation of oral feeding post-caesarean section has been demonstrated to be safe and beneficial for postoperative gastrointestinal function and patient recovery. Objective: To evaluate the safety and benefits of immediate oral feeding on postoperative gastrointestinal function and patient recovery in comparison to early feeding (current practice) following uncomplicated caesarean sections at the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, 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 Oral feeding following uncomplicated caesarean section
Purpose of the trial Oral feeding following uncomplicated caesarean section
Anticipated trial start date 01/07/2022
Actual trial start date 01/07/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/12/2022
Anticipated target sample size (number of participants) 162
Actual target sample size (number of participants) 162
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral feeds 100 ml of water 2 hours post caesarean section then 100 ml of pap 4 hours after then normal diet 4 hours after 10 hours post caesarean section Immediate oral feeding post caesarean section 81
Control Group Oral feeding post caesarean section 100 ml of water 6 hours post caesarean section then 100 ml of pap 4 hours after water then normal diet 4 hours after pap 14 hours post caesarean section Early oral feeding post caesarean section 81 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting pregnant women who undergo elective and emergency uncomplicated caesarean sections under regional anesthesia (spinal, epidural and combined spinal-epidural) will be recruited for the study. 1. Caesarean sections involving bladder, ureteral, intestinal or uterine artery injury 2. Caesarean sections involving blood loss >1,000 ml 3. Caesarean sections involving extensive adhesions/adhesiolysis or/and extensive bowel handling 4. Caesarean sections performed under general anaesthesia 5. Patients with prolonged obstructed labour or obstructed labour with features suggestive of sepsis or/and peritonitis 6.Patients with severe and uncontrolled medical conditions eg diabetes mellitus, preeclampsia/eclampsia, chronic kidney and liver disease or/and requiring intensive care 7. Chronic gastrointestinal disorders such as chronic constipation, irritable bowel syndrome, malabsorption disorders Adult: 19 Year-44 Year 18 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 14/06/2022 Obafemi Awolowo University Teaching Hospitals Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Ile Ife Ile Ife 22202 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the return of postoperative gastrointestinal function and occurrence of paralytic ileus between immediate and early oral feeding following uncomplicated caesarean sections at the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria. Post caesarean section
Secondary Outcome 1. To compare the times to return of bowel sounds, passage of flatus, and passage of stool between the immediate and early oral feeding groups. 2. To compare the occurrence of ileus between the two feeding groups. 3. To compare the time to ambulation, commencement of normal diet, and breastfeeding between the two feeding groups. 4. To compare maternal satisfaction between the two feeding groups using a visual analog tool. From immediate post caesarean section until discharge of the patient
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex Ile Ife Ile Ife 22202 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Akaninyene Ubom Ile Ife Ile Ife 22202 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Akaninyene Ubom Ile Ife Ile Ife 22202 Nigeria Self
COLLABORATORS
Name Street address City Postal code Country
Prof O. B. Fasubaa Ile Ife Ile Ife 22202 Nigeria
Prof E. O. Orji Ile Ife Ile Ife 22202 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Akaninyene Ubom bedom2001@yahoo.com +2348034398468 Ile Ife
City Postal code Country Position/Affiliation
Ile Ife 22202 Nigeria Specialist Registrar Obafemi Awolowo University Teaching Hospitals Complex Ile Ife Nigeria
Role Name Email Phone Street address
Public Enquiries Akaninyene Ubom bedom2001@yahoo.com +2348034398468 Ile Ife
City Postal code Country Position/Affiliation
Ile Ife 22202 Nigeria Specialist Registrar Obafemi Awolowo University Teaching Hospitals Complex Ile Ife Nigeria
Role Name Email Phone Street address
Scientific Enquiries Akaninyene Ubom bedom2001@yahoo.com +2348034398468 Ile Ife
City Postal code Country Position/Affiliation
Ile Ife 22202 Nigeria Specialist Registrar Department of Obstetrics Gynaecology and Perinatology Obafemi Awolowo University Teaching Hospitals Complex Ile Ife Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial will be shared, after deidentification. Informed Consent Form,Study Protocol Within three month of study completion Anyone who wants access to the data
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