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.: PACTR202609469206556 Date of Registration: 07/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Randomized Controlled Trial of single-dose versus extended-dose prophylactic antibiotic for caesarean section in Modibbo Adama University Teaching Hospital, Yola
Official scientific title Randomized Controlled Trial of single-dose versus extended-dose prophylactic antibiotic for caesarean section in Modibbo Adama University Teaching Hospital, Yola
Brief summary describing the background and objectives of the trial Randomized Controlled Trial of single-dose versus extended-dose prophylactic antibiotic for caesarean section in Modibbo Adama University Teaching Hospital, Yola. This study seeks to compare the effectiveness of single-dose regimen and extended-doses of antibiotic regimen for preventing post caesarean section surgical site infection in Modibbo Adama University Teaching Hospital Yola, Adamawa Nigeria. Specific objectives was post-caesarean section surgical site infections, duration of hospital stay and febrile morbidity between the two groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2025
Actual trial start date 16/06/2025
Anticipated date of last follow up 22/01/2026
Actual Last follow-up date 29/01/2026
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 232
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 prophylaxis cefuroxime1.5g stat within 30minute of the start of the surgery stat After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 1.5g vial was reconstituted with 10mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. All post-operative care were followed standard clinical practice. Postoperatively patients were placed on intravenous fluid and analgesics. Both were placed on analgesic, intravenous fluid and haematinics. Urethral catheter was removed after 12 hours post operation to ensure early ambulation while intravenous cannula is removed after completion of intravenous medication. 116
Control Group extended dose 1.5g pre-inscision then 2 other similar doses 8 hourly 24 hours After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 1.5g was reconstituted with 10mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. 1.5g pre-inscision then 2 other similar doses 8 hourly 116 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All pregnant women booked for caesarean section during the period of the study, with no added risk for infection, who consented will be included allergic to Cefuroxime those who had any infection in previous two weeks presented with fever (T 380C or more) rupture of membranes established labour patient with HIV/AIDS diabetic mellitus cardiac disease renal disease obesity (BMI ≥ 25kg/m²) eclampsia anaemia those who refuse to consent Adult: 18 Year(s)-44 Year(s) 18 Year(s) 45 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 06/05/2025 Health Research Ethics Committee Modibbo Adama University Teaching Hospital Yola
Ethics Committee Address
Street address City Postal code Country
Lamido Zubairu way, Yola bypass, Yola south, Adamawa state Nigeria Yola 640210 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome presence of surgical site infection Fever and tenderness after 24hour, discharge and change of colour after 3 days, and swab MCS result till day 14
Secondary Outcome duration of hospital stay and febrile morbidity After 24hours till day 14
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MODIBBO ADAMA UNIVERSITY TEACHING HOSPITAL YOLA Lamido Zubairu way, Yola bypass, Yola South Adamawa state, Nigeriaa Yola 640210 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Aliyu Ibrahim Maina Lelewalji, off Modibbo Raji street Yola town, Adamawa state, Nigeria Yola 640101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Aliyu Ibrahim Maina Lelewaji, off modibbo Raji street, Yola Town, Adamawa State Nigeria Yola 640101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliyu Maina docaimaina@gmail.com +2348032971494 Lelewalji off Modibbo Raji street Yola town, Nigeria
City Postal code Country Position/Affiliation
Yola 640101 Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Inuwa Umaru juyoh20@gmail.com +2348035763388 Dept. of O and G MAUTH Yola
City Postal code Country Position/Affiliation
Yola 640101 Nigeria Consultant O and G Head of department
Role Name Email Phone Street address
Scientific Enquiries Ehalaiye Bolurin ehabolurin@gmail.com +2348034125957 Dept. of O and G MAUTH Yola
City Postal code Country Position/Affiliation
Yola 640101 Nigeria Chief Consultant O and G and supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data that would be shared is for individual participant data that underlie the results obtained from the trial. the data will be made available immediately after publication the data would be available for any researcher who wishes to access it. the data could be used for individual participant meta-analysis the link to access for the data would be made available after publication Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year open accwss
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/03/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/03/2026 Result - 09/03/2026 Result - 09/03/2026 Result - 09/03/2026 Result - 09/03/2026
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 21/03/2026 The letters was change to capital and small letter RANDOMIZED CONTROLLED TRIAL OF SINGLE-DOSE VERSUS EXTENDED-DOSES PROPHYLACTIC ANTIBIOTIC FOR CAESAREAN SECTION IN MODIBBO ADAMA UNIVERSITY TEACHING HOSPITAL, YOLA Randomized Controlled Trial of single-dose versus extended-dose prophylactic antibiotic for caesarean section in Modibbo Adama University Teaching Hospital, Yola
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 21/03/2026 The letters was change to capital and small letter RANDOMIZED CONTROLLED TRIAL OF SINGLE-DOSE VERSUS EXTENDED-DOSES PROPHYLACTIC ANTIBIOTIC FOR CAESAREAN SECTION IN MODIBBO ADAMA UNIVERSITY TEACHING HOSPITAL, YOLA Randomized Controlled Trial of single-dose versus extended-dose prophylactic antibiotic for caesarean section in Modibbo Adama University Teaching Hospital, Yola
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 21/03/2026 The letters was change to capital and small letter RANDOMIZED CONTROLLED TRIAL OF SINGLE-DOSE VERSUS EXTENDED-DOSES PROPHYLACTIC ANTIBIOTIC FOR CAESAREAN SECTION IN MODIBBO ADAMA UNIVERSITY TEACHING HOSPITAL, YOLA. This study seeks to compare the effectiveness of single-dose regimen and extended-doses of antibiotic regimen for preventing post caesarean section surgical site infection in Modibbo Adama University Teaching Hospital Yola, Adamawa Nigeria. Specific objectives was post-caesarean section surgical site infections, duration of hospital stay and febrile morbidity between the two groups. Randomized Controlled Trial of single-dose versus extended-dose prophylactic antibiotic for caesarean section in Modibbo Adama University Teaching Hospital, Yola. This study seeks to compare the effectiveness of single-dose regimen and extended-doses of antibiotic regimen for preventing post caesarean section surgical site infection in Modibbo Adama University Teaching Hospital Yola, Adamawa Nigeria. Specific objectives was post-caesarean section surgical site infections, duration of hospital stay and febrile morbidity between the two groups.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 21/03/2026 Number of targeted sample size per group 240 120
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 21/03/2026 Number of final participants who completed the studies per group 232 116
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 30/08/2026 Clarification reviewers request 116 232
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 30/08/2026 Hint All pregnant women booked for caesarean section during the period of the study, with no added risk for infection, who consented will be included All pregnant women booked for caesarean section during the period of the study, with no added risk for infection, who consented will be included
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/03/2026 intervention name was corrected as well as final sample Experimental Group, prophylaxis, cefuroxime 750mg stat within 30minute of the start of the surgery, stat, After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 750mg vial was reconstituted with 5mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. All post-operative care were followed standard clinical practice. Postoperatively patients were placed on intravenous fluid and analgesics. Those in the control group was placed on intravenous Cefuroxime 750mg 8hourly for 24 hours. Both were placed on analgesic, intravenous fluid and haematinics. Urethral catheter was removed after 12 hours post operation to ensure early ambulation while intravenous cannula is removed after completion of intravenous medication. , 120, Experimental Group, prophylaxis, cefuroxime 750mg stat within 30minute of the start of the surgery, stat, After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 750mg vial was reconstituted with 5mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. All post-operative care were followed standard clinical practice. Postoperatively patients were placed on intravenous fluid and analgesics. Those in the control group was placed on intravenous Cefuroxime 750mg 8hourly for 24 hours. Both were placed on analgesic, intravenous fluid and haematinics. Urethral catheter was removed after 12 hours post operation to ensure early ambulation while intravenous cannula is removed after completion of intravenous medication. , 116,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/08/2026 Clarification Experimental Group, prophylaxis, cefuroxime 750mg stat within 30minute of the start of the surgery, stat, After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 750mg vial was reconstituted with 5mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. All post-operative care were followed standard clinical practice. Postoperatively patients were placed on intravenous fluid and analgesics. Those in the control group was placed on intravenous Cefuroxime 750mg 8hourly for 24 hours. Both were placed on analgesic, intravenous fluid and haematinics. Urethral catheter was removed after 12 hours post operation to ensure early ambulation while intravenous cannula is removed after completion of intravenous medication. , 116, Experimental Group, prophylaxis, cefuroxime1.5g stat within 30minute of the start of the surgery, stat, After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 1.5g vial was reconstituted with 10mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. All post-operative care were followed standard clinical practice. Postoperatively patients were placed on intravenous fluid and analgesics. Both were placed on analgesic, intravenous fluid and haematinics. Urethral catheter was removed after 12 hours post operation to ensure early ambulation while intravenous cannula is removed after completion of intravenous medication. , 232,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/08/2026 Clarification Experimental Group, prophylaxis, cefuroxime1.5g stat within 30minute of the start of the surgery, stat, After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 1.5g vial was reconstituted with 10mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. All post-operative care were followed standard clinical practice. Postoperatively patients were placed on intravenous fluid and analgesics. Both were placed on analgesic, intravenous fluid and haematinics. Urethral catheter was removed after 12 hours post operation to ensure early ambulation while intravenous cannula is removed after completion of intravenous medication. , 232, Experimental Group, prophylaxis, cefuroxime1.5g stat within 30minute of the start of the surgery, stat, After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 1.5g vial was reconstituted with 10mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. All post-operative care were followed standard clinical practice. Postoperatively patients were placed on intravenous fluid and analgesics. Both were placed on analgesic, intravenous fluid and haematinics. Urethral catheter was removed after 12 hours post operation to ensure early ambulation while intravenous cannula is removed after completion of intravenous medication. , 116,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/03/2026 intervention name was corrected as well as final sample Control Group, extended dose, 750mg 8 hourly for 24 hours, 24 hours, After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 750mg vial was reconstituted with 5mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. Those in the control group was placed on intravenous Cefuroxime 750mg 8hourly for 24 hours., 116, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/08/2026 intervention name was corrected as well as final sample Control Group, extended dose, 750mg 8 hourly for 24 hours, 24 hours, After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 750mg vial was reconstituted with 5mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. Those in the control group was placed on intravenous Cefuroxime 750mg 8hourly for 24 hours., 116, Active-Treatment of Control Group Control Group, extended dose, 1.5g pre-inscision then 2 other similar doses 8 hourly, 24 hours, After obtaining informed consent for participation in the research as well as the caesarean section, the drugs was administered by the anaesthetists within 30 minutes before skin incision. Cefuroxime 1.5g was reconstituted with 10mls of sterile water for injection and given as IV slowly over 2-3 minutes, within 10 minutes of reconstitution. 1.5g pre-inscision then 2 other similar doses 8 hourly, 116, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/03/2026 clarification on the timeline of checking primary outcome Primary Outcome, presence of surgical site infection, Fever and tenderness after 24hour, discharge and change of colour after 3 days, and swab MCS result till day 14
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/03/2026 clarification on the timeline of checking secondary outcome Secondary Outcome, duration of hospital stay and febrile morbidity, After 24hours till day 14