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.: PACTR202004658330781 Date of Approval: 28/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SINGLE DOSE VERSUS MULTIPLE DOSES ANTIBIOTIC PROPHYLAXIS IN CAESAREAN SECTION: A RANDOMIZED CONTROL TRIAL
Official scientific title SINGLE DOSE VERSUS MULTIPLE DOSES ANTIBIOTIC PROPHYLAXIS IN CAESAREAN SECTION: A RANDOMIZED CONTROL TRIAL
Brief summary describing the background and objectives of the trial Cesarean section, one of the most common obstetric surgical procedures with an increasing incidence is a major predisposing factor for puerperal infections, requiring the need for antibiotics prophylaxis.Evidence from large number of studies suggests that single dose antibiotics prophylaxis have comparable efficacy to multiple doses with less cost and risk of antibiotic resistance. However, single dose antibiotic prophylaxis for caesarean sections is not generally used in many centers in sub-Saharan Africa. The aim of this study is to compare the effectiveness of single dose versus multiple doses prophylactic antibiotics in the prevention of post Cesarean section infectious morbidity.
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 cesarean section
Purpose of the trial Treatment: Drugs
Anticipated trial start date 19/04/2020
Actual trial start date 01/05/2020
Anticipated date of last follow up 28/08/2020
Actual Last follow-up date 28/08/2020
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group multiple dosing regimen IV Ceftriaxone 1g and IV Metronidazole 500mg within 1 hour before cesarean section, then repeat 12 hourly and 8 hourly respectively for 48 hours; then Tab Cefuroxime 500mg and Tab Metronidazole 400mg tds for 5 days seven days multiple dose Preoperative Antibiotic prophylactic 81 Dose Comparison
Experimental Group single preoperative antibiotic dose single dose Once...preoperative Single dose of IV ceftriaxone 1g and Metronidazole 500mg within 60 mins of incision time st 81
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Patients admitted for caesarean section both emergency and elective ii. Patients who will give written informed consent to the study. i. Patients with prolonged labour ii. Patients with known allergy to any of the drugs iii. Patients on antibiotic therapy or who received antibiotics in the preceding 2 weeks iv. Patients with chorioamnionitis v. Prolonged rupture of membranes(>24 hours) vi. Pre-operative Hemoglobin<10gm/dl vii. Maternal weight >100kg viii. Diabetic patients with poor glucose control ix. Sickle cell disease patients x. HIV1 and HIV2 positive patients Adult: 19 Year-44 Year 19 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 11/10/2019 Health Research Ethics committee Federal Medical center Keffi
Ethics Committee Address
Street address City Postal code Country
05, Old Akwanga road, Keffi Keffi 961101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome  Wound infection 3-14 days post-operation
Secondary Outcome  Postoperative fever  Clinical endometritis 2-14 days post-cesarean section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
federal Medical Center Keffi 05 Old Akwanga road, Keffi keffi 961101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Igwemadu Gerald Plot 840 cadastral zone BO 1, Gudu District Abuja 900104 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Gerald Igwemadu Plot 840, Zone B1 Cadastral, Durumi 1 Abuja 900104 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Pam Samuel department of obstetrics and gynecology keffi 961101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gerald Igwemadu alkellygerald@gmail.com 2348036486044 Plot 840 Zone B1 cadastral, Durmi1
City Postal code Country Position/Affiliation
Abuja 900104 Nigeria Specialist Registrar
Role Name Email Phone Street address
Scientific Enquiries Uche Akunaeziri akunaeziriu@gmail.com 2348036302463 10 lowcost estate
City Postal code Country Position/Affiliation
Keffi 961101 Nigeria Consultant Obstetric and Gynecology FMC keffi
Role Name Email Phone Street address
Public Enquiries Folashade Afolabi drafolabiaf@gmail.com 2348033734508 12 Low cost estate
City Postal code Country Position/Affiliation
Keffi 961101 Nigeria Consultant Obstetrician and Gynecology FMC Keffi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that underlie results in a publication Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 3 months to 3 years after publication Any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
To be provided after completion of study 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