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.: PACTR202407476433553 Date of Approval: 22/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Single Dose Versus Five-day Course of Oral Ciprofloxacin as Prophylaxis After Manual Vacuum Aspiration for Incomplete Miscarriage In Gusau: A Randomized Controlled Trial
Official scientific title Single Dose Versus Five-day Course of Oral Ciprofloxacin as Prophylaxis After Manual Vacuum Aspiration for Incomplete Miscarriage In Gusau: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: The use of prophylactic antibiotics following surgical management of miscarriage has been shown to reduce post abortion infection. However, there is paucity of data most especially in the sub-Saharan Africa on an effective antibiotic regimen in its prevention. Objectives: To determine if there is a significant difference in outcome of patients following the use of single dose versus 5-day course of oral Ciprofloxacin as antibiotic prophylaxis for manual vacuum aspiration (MVA) in incomplete miscarriages in Federal Medical Centre, Gusau.
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 Abortion
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/07/2023
Actual trial start date 10/07/2023
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date 31/03/2024
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants) 128
Recruitment status Recruiting
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A 1 dose of oral ciprofloxacin 500mg once One dose of oral ciprofloxacin 500mg 64
Control Group Group B five day course of oral ciprofloxacin 500mg 12hourly 5 days Five day course of oral ciprofloxacin 500mg 12hourly 64 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Women with incomplete miscarriage. 2. Women who consent for MVA for management of miscarriage and agree to participate in the study. 3. Women who agree to follow up visit in the hospital or at least telephone follow up for clients living far from the hospital. 1. Allergy to fluoroquinolones. 2. Contraindications to fluoroquinolones (e.g., breastfeeding patients) 3. Clinical suspicion of infection. 4. Those who present with incomplete abortion after an unsafe abortion. 5. Those who are on antibiotic therapy or in the last one week for other reasons. 6. Immunosuppressive state 7. Patients not able to take orally Adult: 19 Year-44 Year 15 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 22/02/2023 Research and Ethics Committee Federal Medical Centre Gusau
Ethics Committee Address
Street address City Postal code Country
Federal Medical Centre, Gusau, Sokoto Bye-Pass Gusau 632101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post abortion sepsis 7 and 14 days post evacuation
Secondary Outcome Side effects, Compliance with medications, duration of bleeding. days 7 and 14 post-evacuation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Gusau Sokoto Bye-Pass Gusau 632101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Sokoto Bye-Pass Gusau 632101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Federal Medical Centre Gusau Sokoto Bye-Pass Gusau 632101 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olaniyi Fasanu nfashtolu@yahoo.com +2347035353990 Federal Medical centre, Gusau
City Postal code Country Position/Affiliation
Gusau 632101 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Olaniyi Fasanu nfashtolu@yahoo.com +2347035353990 Sokoto bye-Pass, Gusau
City Postal code Country Position/Affiliation
Gusau 632101 Nigeria Senior registrar Federal Medical Centre Gusau
Role Name Email Phone Street address
Scientific Enquiries Olaniyi Fasanu nfashtolu@yahoo.com +2347035353990 Sokoto Bye-Pass
City Postal code Country Position/Affiliation
Gusau 632101 Nigeria Senior registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data collected during the trial, after deidentification, will be made available. Study Protocol 1 year clinical researchers
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