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.: PACTR202405865325160 Date of Approval: 14/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy Of Pre-caesarean Povidone-iodine Vaginal Cleansing in Preventing Surgical Site Infection at ATBUTH Bauchi: A Randomized Controlled Trial
Official scientific title Efficacy Of Pre-caesarean Povidone-iodine Vaginal Cleansing in Preventing Surgical Site Infection at ATBUTH Bauchi: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Caesarean section (CS) is one of the most common obstetrics procedures, and the rate is increasing globally with a consequential increase in surgical complications, including surgical site infection (SSI). Post-caesarean section SSI, which includes wound infection and endometritis, occurs despite standard infection prevention measures (such as preoperative skin preparation and prophylactic antibiotics) and is associated with significant maternal morbidity and mortality. Vaginal cleansing with povidone-iodine, an uncommon practice whose benefit is uncertain, could be an additional significant prevention of surgical site infection. Objective: To determine the efficacy of vaginal cleansing with 10% povidone-iodine in reducing post-caesarean section surgical site infection among women who had caesarean section at ATBUTH, Bauchi.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied post-caesarean section surgical site infection
Purpose of the trial Prevention
Anticipated trial start date 02/05/2024
Actual trial start date
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants)
Recruitment status Active, not 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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vaginal cleansing 10% with 3 swabs 30sec preoperative vaginal cleansing with with 3 swabs soaked 10% povidone-iodine for 30 seconds: the first to clean the vulva and the other two to clean the vagina after anaesthesia before scaesrean section 54
Control Group control NIl Not applicable no vaginal cleansing before a cesarean section 54 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All consenting pregnant women admitted to ATBUTH Bauchi for either an elective or emergency caesarean section 2. Gestational age: ≥28 weeks. 1. Subjects known to be hypersensitive to povidone-iodine 2. Presence of features of subclinical/clinical chorioamnionitis 3. HIV in Pregnancy 4. Diabetes mellitus in pregnancy 5. Patient on long time steroid intake 6. Unconscious patient 7. Patients with cord prolapse, face presentation with ruptured membranes or placenta previa Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 45 Year(s) Female
1. All consenting pregnant women admitted to ATBUTH Bauchi for either an elective or emergency caesarean section 2. Gestational age: ≥28 weeks. 1. Subjects known to be hypersensitive to povidone-iodine 2. Presence of features of subclinical/clinical chorioamnionitis 3. HIV in Pregnancy 4. Diabetes mellitus in pregnancy 5. Patient on long time steroid intake 6. Unconscious patient 7. Patients with cord prolapse, face presentation with ruptured membranes or placenta previa 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 19/04/2024 Research and Ethics ATBUTH Bauchi
Ethics Committee Address
Street address City Postal code Country
Hospital road, off yandoka street Bauchi 740101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Surgical Site Infection: wound infection will be diagnosed when the surgical wound has either oedema, erythema, discharge, exudate, hematoma, novel undue tenderness at incisional site or wound gaping with or without or fever (temperature of ≥380C) requiring antibiotics. These will be assessed on day three after surgery when the wound will be opened for inspection. Endometritis will be diagnosed by presence of any two of the following; fever (temperature of ≥380C) after 24 hours, lower abdominal pain, novel undue uterine tenderness, uterine subinvolution or offensive vaginal discharge. within 30 days postoperative period, after intervention
Secondary Outcome Onset of SSI, febrile morbidity (temperature of ≥380C), reaction to povidone-iodine (itching, erythema, blister at the application area), burst abdomen, septic shock, and death attributed to infection among study groups within 30 days postoperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Abubakar Tafawa BAlewa University Teaching Hospital Bauchi Hospital road, off Yandoka street Bauchi 740101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self hospital road, off Yandoka Bauchi 740101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self Hospital road, off Yandoka Bauchi 740101 Nigeria other
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Musliu Abdulraheem musliuabdulraheem@yahoo.com +2347039642574 Hospital road, off yandoka
City Postal code Country Position/Affiliation
Bauchi 740101 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Ismail Tiamiyu Tiamiyuismail21@yahoo.com +2348066967221 hospital road
City Postal code Country Position/Affiliation
Bauchi 740101 Nigeria Unit consultant
Role Name Email Phone Street address
Scientific Enquiries Lamaran Dattijo Lamaran2@yahoo.com +2348036301549 hospital road, off Yandoka streat
City Postal code Country Position/Affiliation
Bauchi 740101 Nigeria unit consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes As we are committed to transparency and scientific collaboration, we intend to share all of the individual participant data that will be collected during the trial. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol This is expected to be available immediately after publication for up to 10 years. Access will be open to anyone who wishes to access the data for any research purpose, such as meta-analysis and systematic review, following a formal request. Data can be requested through an email sent to the principal investigator.
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