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.: PACTR202009483150226 Date of Approval: 07/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title COMPARISON OF SINGLE VERSUS MULTIPLE DOSE (AMOXICILLIN/CLAVULANIC ACID) ANTIMICROBIAL PROPHYLAXIS FOR CAESAREAN SECTION IN FEDERAL TEACHING HOSPITAL GOMBE, NIGERIA - A RANDOMIZED CONTROLLED TRIAL
Official scientific title COMPARISON OF SINGLE VERSUS MULTIPLE DOSE (AMOXICILLIN/CLAVULANIC ACID) ANTIMICROBIAL PROPHYLAXIS FOR CAESAREAN SECTION IN FEDERAL TEACHING HOSPITAL GOMBE, NIGERIA - A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Introduction Caesarean section increases the risk for surgical site infection. Antimicrobial prophylaxis (AMP) is one of the key measures employed to reduce this risk. However, there is inadequate uptake of the recommendation for a single dose regimen leading to frequent use of multiple doses which are mostly started postoperatively with increased risk of surgical site infection and morbidity added to increased cost of health care. Aim To compare the efficacy of single dose antimicrobial prophylaxis with multiple doses for caesarean section at Federal Teaching Hospital Gombe. Objective To determine the post-caesarean surgical site infection rate in patients who receive single dose AMP and in those with multiple doses and compare them. Methods One hundred and seventy-six (176) women undergoing elective and emergency caesarean section were randomized, by blocking, into group ‘A’ which received a single dose of intravenous Amoxicillin/Clavulanic acid prior to skin incision and ‘B’ which had the same antibiotic prior to the operation in addition to postoperative doses for 24 - 48 hours and then the oral formulation for 5 – 7 days. The primary outcome measure was surgical site infection during a 30-day surveillance period. The data were analyzed using SPSS version 20.0 (Armonk, NY: IBM Corp.). Chi Square Test, Independent Sample T-test and Fisher’s exact test were used in the analysis.
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 Postcaesarean surgical site infection
Purpose of the trial Prevention
Anticipated trial start date 22/07/2019
Actual trial start date 22/07/2019
Anticipated date of last follow up 23/01/2020
Actual Last follow-up date 23/01/2020
Anticipated target sample size (number of participants) 176
Actual target sample size (number of participants) 174
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Single dose Preincision Amoxicillin Clavulanic acid 1.2 g intravenously stat dose The drug is administered within 60 minutes before skin incision 86
Control Group Multiple doses of Amoxicillin Clavulanic acid 1.2g stat before skin incision then 12 hourly for 24-48 hours postoperatively, followed by oral drugs bid For 5 to 7 days Multiple doses with first dose given within 60 minutes before skin incision 88 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Pregnant women booked for elective or emergency caesarean delivery • Patients who gave informed consent • Women with immunosuppression such as those with HIV infection and uncontrolled diabetes mellitus • Features of chorioamnionitis such as foul-smelling lochia, tender uterus and fever • Moderate to severe anaemia (haemoglobin concentration less than 8g/dl) or packed cell volume (PCV) of less than 24%. • Ruptured membranes more than 8 hours • Active phase of labour more than 8 hours • Multiple vaginal examinations (more than 3) • Known allergy to any of the drugs to be used Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 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 19/12/2018 Research and Ethics Committee Federal Teaching Hospital Gombe
Ethics Committee Address
Street address City Postal code Country
Ashaka Road Gombe Gombe 0037 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of surgical site infection During a 30-day post-operative surveillance
Secondary Outcome Occurence of Urinary Tract Infection During a 30-day post-operative surveillance
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology Federal Teaching Hospital Gombe Ashaka Road Gombe 0037 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Sagir Muhammad Ashaka Road Gombe Gombe 0037 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sagir Muhammad Ashaka Road Gombe 0037 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
DR SAGIR MUHAMMAD ASHAKA ROAD PMB 0037 FEDERAL TEACHING HOSPITAL GOMBE GOMBE Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sagir Muhammad sagirmuhammad2013@gmail.com 2348034309414 Ashaka Road
City Postal code Country Position/Affiliation
Gombe 0037 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Sagir Muhammad sagirmuhammad2013@gmail.com 2348034309414 Ashaka Road
City Postal code Country Position/Affiliation
Gombe 0037 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Sagir Muhammad sagirmuhammad2013@gmail.com 2348034309414 Ashaka road
City Postal code Country Position/Affiliation
Gombe 0037 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the proposed article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Study Protocol Immediately following publication, no end date Anyone who wishes to access 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