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.: PACTR202509662932971 Date of Registration: 11/09/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Return to Routine Household and Community Function Following Uncomplicated Caesarean Delivery: Ultra-short stay Versus Traditional Hospital-stay Protocol.
Official scientific title Return to Routine Household and Community Function Following Uncomplicated Caesarean Delivery: Ultra-short stay Versus Traditional Hospital-stay Protocol. A Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Caesarean delivery is presently the commonest major obstetric procedure, and length of hospital stay following this procedure varies from centre to centre. There is need to examine the psychophysical and socio-economic implications of recovery following Caesarean delivery, especially with regards to return to household and community function. Aim: To determine and compare the time of return to household and community function, patient perception and satisfaction with Caesarean delivery; and safety, between the ultra-short stay and traditional post-operative management protocol, following uncomplicated Caesarean delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied caesarean section
Purpose of the trial Post-0perative management protocol following uncomplicated caesarean section
Anticipated trial start date 08/01/2024
Actual trial start date 01/04/2024
Anticipated date of last follow up 01/04/2025
Actual Last follow-up date 28/04/2025
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 179
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultrashort stay postoperative management protocol following uncomplicated caesarean section Chewing of minty chewing gums for 2 hours in the first 6 hours after caesarean section ultra-short hospital stay after uncomplicated caesarean section - 36 to 48 hours The women in the ultra-short stay group were given minty chewing gums (menthos) to chew for 2 hours, within the first 6 hours after surgery. They started ambulating and oral intake initiated from 6 hours post-operative (regular diet commenced at 12 hours); and urethral catheter discontinued 6-12 hours post-operative. The wounds were inspected, exposed and the patient discharged at 36 to 48 hours post-operative 90
Control Group Traditional postoperative management protocol Nothing given to chew in the first 24 hours Traditional hospital stay - 3 to 5 days The women in the traditional group were ambulant from 12 to 24 hours, oral intake initiated and urethral catheter discontinued at 24 hours post-operative. In the traditional group, the wounds were inspected and exposed and patient discharged on the third to fifth post-operative day 89 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. The patient was a booked antenatal patient and was being attended to in the facilities, and consequently has an antenatal record. 2. The patient had just had an uncomplicated caesarean delivery. 3. The patient is fully awake. 4. Informed verbal and written consent had been obtained. 1. Presence of any obstetric/medical condition that required co-management with other specialities post-delivery, and may therefore warrant prolonged hospital stay. 2. Immunosuppressed women or those with HIV infection who already had features of the Acquired Immune Deficiency Syndrome (AIDS). 3. Patients who had prolonged labour or conditions that increase risk of sepsis, like prolonged pre-labour rupture of membranes Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 49 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 05/01/2024 Research Ethics Committee Federal Medical Centre Yenagoa
Ethics Committee Address
Street address City Postal code Country
Ovom Yenagoa Yenagoa PMB 502 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome variables are the time interval to return of routine household function (breast feeding, bathing and changing diapers for the baby, house chores/house-keeping, cooking and coitus) in number of days; time to return of community function (going to market, shopping malls, worship centres, social functions, visits, work/business and travel). Number of days from caesarean section to return of function
Secondary Outcome Secondary outcome variables include patient perception of caesarean section and satisfaction with care; rate of wound sepsis (painful redness and swelling or induration of wound edges, seropurulent/purulent discharge or dehiscence), spinal headache, puerperal sepsis, and readmission to hospital; and care-giver’s perception of caesarean section and patients’ return to function. within first 6 weeks after caesarean delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Yenagoa Ovom Yenagoa Bayelsa state PMB 502 Nigeria
Niger Delta University Teaching Hospital Okolobiri Bayelsa State Nigeria
Diete Koki Memorial Hospital Opolo Yenagoa Bayelsa State Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nuvie Oyeyemi okaka Housing Estate Yenagoa PMB 502 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self okaka Housing Estate Yenagoa PMB 502 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator NUVIE OYEYEMI nuviyemi@yahoo.com +2348035488675 OKAKA HOUSING ESTATE
City Postal code Country Position/Affiliation
YENAGOA PMB 502 Nigeria Consultant in the Department of Obstetrics and Gynaecology Federal Medical Centre Yenagoa
Role Name Email Phone Street address
Public Enquiries Dibo Pughikumo dibopughikumo@yahoo.com +2348167038228 Wilberforce island
City Postal code Country Position/Affiliation
Amassoma PMB 502 Nigeria Department of Physiology College of Health Sciences Niger Delta University Wilberforce Island Bayelsa State Nigeria.
Role Name Email Phone Street address
Scientific Enquiries Uche Onwudiegwu uonwudiegwu@yahoo.com +2348065984191 ingbi Road
City Postal code Country Position/Affiliation
Yenagoa PMB 502 Nigeria Institute of Medical Education Bayelsa Medical University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants names were not entered into the statistical software (IBM SPSS statistical software version 25) for analysis, and will not be shared in publications Informed Consent Form,Study Protocol One year proformas and interviewer-administered questionaires
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 17/08/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 04/09/2025 Result - 04/09/2025 Result - 04/09/2025 Result - 04/09/2025 Result - 04/09/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 03/09/2025 Public title should not be in capital letters only RETURN TO ROUTINE HOUSEHOLD AND COMMUNITY FUNCTION FOLLOWING UNCOMPLICATED CAESAREAN DELIVERY: ULTRA-SHORT STAY VERSUS TRADITIONAL HOSPITAL-STAY PROTOCOL. Return to Routine Household and Community Function Following Uncomplicated Caesarean Delivery: Ultra-short stay Versus Traditional Hospital-stay Protocol.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 03/09/2025 Scientific title should not be in capital letter only RETURN TO ROUTINE HOUSEHOLD AND COMMUNITY FUNCTION FOLLOWING UNCOMPLICATED CAESAREAN DELIVERY: ULTRA-SHORT STAY VERSUS TRADITIONAL HOSPITAL-STAY PROTOCOL. A RANDOMIZED CONTROLLED TRIAL Return to Routine Household and Community Function Following Uncomplicated Caesarean Delivery: Ultra-short stay Versus Traditional Hospital-stay Protocol. A Randomized Controlled Trial.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 30/08/2025 To include all applicable age groups Adult: 19 Year-44 Year Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 30/08/2025 To separate the names of the different centres used for the trial (all in the same state), which were initially written together in the previous submission Federal Medical Centre Yenagoa Niger Delta University Hospital Okolobiri Diete Koki Memorial Hospital Opolo, Ovom Okolobiri Opolo, Yenagoa Bayelsa state, 502, Nigeria Federal Medical Centre Yenagoa , Ovom , Yenagoa Bayelsa state, 502, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 30/08/2025 To separate the names of the different centres used for the trial (all in the same state), which were initially written together in the previous submission Federal Medical Centre Yenagoa , Ovom , Yenagoa Bayelsa state, 502, Nigeria Federal Medical Centre Yenagoa , Ovom , Yenagoa Bayelsa state, PMB 502, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 30/08/2025 To separate the names of the different centres used for the trial (all in the same state), which were initially written together in the previous submission Niger Delta University Teaching Hospital, Okolobiri, Bayelsa State, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 30/08/2025 To separate the names of the different centres used for the trial (all in the same state), which were initially written together in the previous submission Diete Koki Memorial Hospital, Opolo, Yenagoa Bayelsa State, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 03/09/2025 Actual name of the principal investigator replacing self, under name of source Self, okaka Housing Estate, Yenagoa, PMB 502, Nigeria, Self Funded, Nuvie Oyeyemi, okaka Housing Estate, Yenagoa, PMB 502, Nigeria, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 04/09/2025 IPD sharing statement included Participants names were not be entered into the statistical software for analysis, and were not be shared in publications Participants names were not entered into the statistical software (IBM SPSS statistical software version 25) for analysis, and will not be shared in publications
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 04/09/2025 Informed consent form for participants and ultra-short stay postoperative management protocol included Study Protocol Study Protocol, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 04/09/2025 Trial results uploaded 36026_25404_1045.pdf 36026_25404_1045.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 2 04/09/2025 Proforma and interviewer-administered questionnaire uploaded 36026_25404_1046.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 3 04/09/2025 Consent form for participants uploaded 36026_25404_1047.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 4 04/09/2025 Ultra-short stay postoperative management protocol uploaded 36026_25404_1048.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 5 04/09/2025 Summary of results uploaded 36026_25404_1049.pdf