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.: PACTR202508897550291 Date of Registration: 14/08/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison Of The Outcomes Of Early Versus Delayed Hospital Discharge After Uncomplicated Caesarean Section At The Rivers State University Teaching Hospital, Port Harcourt: A Randomized Clinical Trial
Official scientific title Comparison Of The Outcomes Of Early Versus Delayed Hospital Discharge After Uncomplicated Caesarean Section At The Rivers State University Teaching Hospital, Port Harcourt: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Caesarean section (CS) is the most common major surgery performed in obstetrics practice. Outcomes and complications are key concerns for the mothers and obstetricians. There has been an increasing interest in issues relating to the management and length of hospital stay following the procedure. The average hospital stay in Nigeria following CS in most hospitals is four to five days, a tradition not based on evidence or practice guidelines. Over the years, especially in the high-income countries, it is becoming common practice to discharge patients early to satisfy their wishes, reduce workload in the hospital and save cost. This study aims to evaluate maternal morbidity outcomes as well as satisfaction associated with early versus late hospital discharge following uncomplicated caesarean delivery, at RSUTH.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EDHDCS
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Post operative Surgical site infection following Caesarean Section
Purpose of the trial Education /Training
Anticipated trial start date 04/08/2025
Actual trial start date 05/09/2025
Anticipated date of last follow up 24/11/2025
Actual Last follow-up date 15/12/2025
Anticipated target sample size (number of participants) 168
Actual target sample size (number of participants) 168
Recruitment status Not yet recruiting
Publication URL None yet
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Delayed Hospital Discharge after Caesarean Section 4 days Oral feeds, removal of urethral catheter, ambulation, discharge home on day 4 after caesarean section 84 Active-Treatment of Control Group
Experimental Group Early Hospital Discharge after Caesarean Section Not applicable 3 Days Removal of Catheter, Commencement of oral feed, Ambulation, Discharge home on day 3 post operatively 84
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women who are to undergo caesarean section (uncomplicated CS) under regional anaesthesia Abnormal lie Breech presentation Repeat CS Cephalopelvic disproportion Fetal distress Women who will require or complicated by: General Anaesthesia Hypertensive disease or other severe medical comorbidities Post pertum haemorrhage Blood transfusion Intraoperative injuries Not consented to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 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 08/05/2025 Rivers State University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
6-8 Harley Street, Old GRA, Port Harcourt Port Harcourt 500241 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Surgical site infection 5 to 14 days post operative
Secondary Outcome Fever, Endometritis, puerperal sepsis 2 days to 4 weeks post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rivers State University Teaching Hospital 4 - 6 Harley Street, Old GRA Port Harcourt 500241 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Silas .E. Ogide 24 Shell Location Road, Off Ada George Road Port Harcourt 500102 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Silas E. Ogide 24 Shell Location Road, Off Ada George Road Port Harcourt 500102 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Silas E Ogide Silogid@yahoo.com +2348037930765 24 Shell Location Road, Off Ada George Road
City Postal code Country Position/Affiliation
Port Harcourt 500102 Nigeria Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Rose .S. Amah sitonamah@gmail.com +2348037418480 4-6 Harley Street, Old GRA
City Postal code Country Position/Affiliation
Port Harcourt 500241 Nigeria Consultant Obstetrician Gynaecologist
Role Name Email Phone Street address
Public Enquiries Silas E Ogide Silogid@yahoo.com +2348037930765 24 Shell Location Road, Off Ada George Road
City Postal code Country Position/Affiliation
Port Harcourt 500102 Nigeria Resident Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Having obtained ethical clearance from the ethical committee, information can only be shared with the express informed consent of the patient Informed Consent Form 12 Months Open Systemic Review and Meta Analysis. Researchers who have passed ethics courses on good clinical practice
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not published yet 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 01/08/2025 Titles changed from capital letters only COMPARISON OF THE OUTCOMES OF EARLY VERSUS DELAYED HOSPITAL DISCHARGE AFTER UNCOMPLICATED CAESAREAN SECTION AT THE RIVERS STATE UNIVERSITY TEACHING HOSPITAL, PORT HARCOURT: A RANDOMIZED CLINICAL TRIAL Comparison Of The Outcomes Of Early Versus Delayed Hospital Discharge After Uncomplicated Caesarean Section At The Rivers State University Teaching Hospital, Port Harcourt: A Randomized Clinical Trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 01/08/2025 Titles changed from capital letters only COMPARISON OF THE OUTCOMES OF EARLY VERSUS DELAYED HOSPITAL DISCHARGE AFTER UNCOMPLICATED CAESAREAN SECTION AT THE RIVERS STATE UNIVERSITY TEACHING HOSPITAL, PORT HARCOURT: A RANDOMIZED CLINICAL TRIAL Comparison Of The Outcomes Of Early Versus Delayed Hospital Discharge After Uncomplicated Caesarean Section At The Rivers State University Teaching Hospital, Port Harcourt: A Randomized Clinical Trial
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 01/08/2025 correction Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Acronym 01/08/2025 Not earlier supplied EDHDCS
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 01/08/2025 As recommended by the reviewer Treatment: Other Education /Training
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 01/08/2025 Not added earlier 05 Sep 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 01/08/2025 New date 15 Dec 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 01/08/2025 Not added earlier 168
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 01/08/2025 Yet to publish None
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 09/08/2025 As indicated by reviewer None None yet
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 09/08/2025 As noted for correction Parallel: different groups receive different interventions at same time during study Crossover: all participants receive all interventions in different sequence during study
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 02/08/2025 According to the instructions Simple randomization using a randomization table created by a computer software program
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 01/08/2025 As recommended by the reviewer Pregnant women who are to undergo caesarean section (uncomplicated CS) under regional anaesthesia, for various indications: Abnormal lie Breech presentation Repeat CS Cephalopelvic disproportion Fetal distress Pregnant women who are to undergo caesarean section (uncomplicated CS) under regional anaesthesia Abnormal lie Breech presentation Repeat CS Cephalopelvic disproportion Fetal distress
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 10/08/2025 As indicated by reviewer for corrections Women who will require or complicated by: General Anaesthesia Severe medical comorbidities like Hypertensive disease Post pertum haemorrhage Blood transfusion Intraoperative injuries Women who will require or complicated by: General Anaesthesia Hypertensive disease or other severe medical comorbidities Post pertum haemorrhage Blood transfusion Intraoperative injuries Not consented to participate
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 02/08/2025 Provided earlier Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 09/08/2025 No change Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year
Section Name Field Name Date Reason Old Value Updated Value
Study Design Masking / blinding 01/08/2025 As recommended by the reviewer Care giver/Provider Care giver/Provider, Participants
Section Name Field Name Date Reason Old Value Updated Value
Study Design Masking / blinding 10/08/2025 As required to effect correction Care giver/Provider, Participants Outcome Assessors, Care giver/Provider, Participants
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/08/2025 Not completed earlier Experimental Group, Early Discharge on Day 3 post operatively, Dose not applicable, 3 Days, Discharge on day 3 post operatively, 84,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 09/08/2025 As required by the reviewer as per correction Control Group, Delayed Hospital Discharge after Caesarean Section, , 4 days, Oral feeds, removal of urethral catheter, ambulation, discharge home on day 4 after caesarean section, 84, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 09/08/2025 Required by the reviewer for correction Experimental Group, Early Hospital Discharge after Caesarean Section, Not applicable, 3 Days, Oral feeds, Removal of Catheter, Ambulation, Discharge home on day 3 post operatively, 84,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/08/2025 To effect corrections as required Experimental Group, Early Hospital Discharge after Caesarean Section, Not applicable, 3 Days, Removal of Catheter, Commencement of oral feed, Ambulation, Discharge home on day 3 post operatively, 84,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/08/2025 As per instruction Control Group, Discharge on day 4 post operatively, Not applicable, 4 Days, Discharge home on day 4 after uncomplicated caesarean section , 84, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/08/2025 As required for correction Primary Outcome, Surgical site infection, 1 to 4 weeks post operative Primary Outcome, Surgical site infection, 5 to 14 days post operative
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 10/08/2025 To effect required corrections Secondary Outcome, Puerperal Sepsis , 1 to 4 weeks post operative Secondary Outcome, Fever, Endometritis, puerperal sepsis , 2 days to 4 weeks post operative
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/08/2025 As per instruction Rivers State University Teaching Hospital , 4 - 6 Harley Street, Old GRA, Port Harcourt, , Nigeria Rivers State University Teaching Hospital , 4 - 6 Harley Street, Old GRA, Port Harcourt, 5000241, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 10/08/2025 To effect necessary correction Rivers State University Teaching Hospital , 4 - 6 Harley Street, Old GRA, Port Harcourt, 5000241, Nigeria Rivers State University Teaching Hospital , 4 - 6 Harley Street, Old GRA, Port Harcourt, 500241, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 02/08/2025 As per instruction of the reviewer TRUE, RIVERS STATE UNIVERSITY TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE, 6-8 HARLEY STREET, OLD GRA, PORT HARCOURT, PORT HARCOURT, 500241, Nigeria, , 08 May 2025, +2348037930765, Silogid@yahoo.com, 34946_33131_4737.pdf TRUE, RIVERS STATE UNIVERSITY TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE, 6-8 HARLEY STREET, OLD GRA, PORT HARCOURT, PORT HARCOURT, 500241, Nigeria, , 08 May 2025, +2348037930765, info@rsuth.ng, 34946_33131_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 10/08/2025 As per instruction of the reviewer to effect corrections TRUE, RIVERS STATE UNIVERSITY TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE, 6-8 HARLEY STREET, OLD GRA, PORT HARCOURT, PORT HARCOURT, 500241, Nigeria, , 08 May 2025, +2348037930765, info@rsuth.ng, 34946_33131_4737.pdf TRUE, Rivers State University Teaching Hospital Health Research Ethics Committee, 6-8 Harley Street, Old GRA, Port Harcourt, Port Harcourt, 500241, Nigeria, , 08 May 2025, +2348037930765, info@rsuth.ng, 34946_33131_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 02/08/2025 As per the instruction of the reviewer SILAS E. OGIDE, 24 Shell Location Road, Mgbuoba, Port Harcourt, 5000102, Nigeria, Self Funded, Dr SILAS E. OGIDE, 24 Shell Location Road, Mgbuoba, Port Harcourt, 5000102, Nigeria, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 10/08/2025 As per the instruction of the reviewer to effect corrections Dr SILAS E. OGIDE, 24 Shell Location Road, Mgbuoba, Port Harcourt, 5000102, Nigeria, Self Funded, Dr Silas .E. Ogide, 24 Shell Location Road, Off Ada George Road, Port Harcourt, 500102, Nigeria, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 10/08/2025 As indicated by the reviewer for corrections Dr Silas E. Ogide, 24 Shell Location Road, Mgbuoba, Port Harcourt, 5000102, Nigeria, Primary Sponsor, Individual, Dr Silas E. Ogide, 24 Shell Location Road, Off Ada George Road, Port Harcourt, 500102, Nigeria, Primary Sponsor, Individual,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 10/08/2025 As indicated by the reviewer for corrections Dr Silas E. Ogide, 24 Shell Location Road, Off Ada George Road, Port Harcourt, 500102, Nigeria, Primary Sponsor, Individual, Dr Silas E. Ogide, 24 Shell Location Road, Off Ada George Road, Port Harcourt, 500102, Nigeria, Primary Sponsor, Hospital,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 02/08/2025 As instructed by the reviewer Dr Silas E. Ogide , 24 Shell Location Road, Mgbuoba, Port Harcourt, , Nigeria, Primary Sponsor, Individual, Dr Silas E. Ogide , 24 Shell Location Road, Mgbuoba, Port Harcourt, 5000102, Nigeria, Primary Sponsor, Individual,
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 10/08/2025 As required to add corrections Principal Investigator, Silas E, Ogide, Dr., Silogid@yahoo.com, , +2348037930765, 24 Shell Location Road, Mgbuoba, Port Harcourt, , Nigeria, Resident Doctor Principal Investigator, Silas E, Ogide, Dr., Silogid@yahoo.com, , +2348037930765, 24 Shell Location Road, Off Ada George Road, Port Harcourt, 500102, Nigeria, Resident Doctor
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 10/08/2025 As required to effect corrections Scientific Enquiries, Rose, Iwoamah, Dr., rosesitonma@yahoo.com, , +2348036197948, 4-6 Harley Street, Old GRA, Port Harcourt, , Nigeria, Consultant Obstetrician Gynaecologist Scientific Enquiries, Rose .S., Amah, Dr., sitonamah@gmail.com, , +2348037418480, 4-6 Harley Street, Old GRA, Port Harcourt, 500241, Nigeria, Consultant Obstetrician Gynaecologist
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 10/08/2025 To add corrections Public Enquiries, Silas E, Ogide, Dr., Silogid@yahoo.com, , +2348037930765, 24 Shell Location Road, Mgbuoba, Port Harcourt, , Nigeria, Resident Doctor Public Enquiries, Silas E, Ogide, Dr., Silogid@yahoo.com, , +2348037930765, 24 Shell Location Road, Off Ada George Road, Port Harcourt, 500102, Nigeria, Resident Doctor
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 02/08/2025 Required as the instruction of the reviewer YES Having obtained ethical clearance from the ethical committee, information can only be shared with the express consent of the patient
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 02/08/2025 Required as per the instruction of the reviewer Having obtained ethical clearance from the ethical committee, information can only be shared with the express consent of the patient Having obtained ethical clearance from the ethical committee, information can only be shared with the express informed consent of the patient
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 02/08/2025 Required Not published yet
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Other Obstetrics and Gynaecology disease 01/08/2025 correction Surgical Outcome Surgical Outcome after Caesarean Section
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Other Obstetrics and Gynaecology disease 02/08/2025 As required Surgical Outcome after Caesarean Section Outcomes after Caesarean Section
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Other Obstetrics and Gynaecology disease 09/08/2025 As indicated by the reviewer Outcomes after Caesarean Section Post operative morbidities following Caesarean Section
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Other Obstetrics and Gynaecology disease 10/08/2025 As required for correction Post operative morbidities following Caesarean Section Post operative Surgical site infection following Caesarean Section