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.: PACTR202306725476304 Date of Approval: 01/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparison of the efficacy of two and three passes of vaginal cleansing with chlorhexidine or placebo before emergency caesarean section in reducing infectious morbidity
Official scientific title A comparison of the efficacy of two and three passes of vaginal cleansing with chlorhexidine or placebo before emergency caesarean section in reducing infectious morbidity
Brief summary describing the background and objectives of the trial Background: Post-caesarean section infectious morbidities have been noted to commonly arise from ascending microbial organism of the vagina despite standard measures for prevention of infections prior to the procedure. Pre-operative vaginal cleansing with Chlorhexidine before caesarean section have been shown to have some benefits, however, the findings are inconclusive. Aim: The aim of this study will be to compare the efficacy of two passes and three passes of pre-operative vaginal cleansing with 2% Chlorhexidine antiseptic solution and placebo prior to emergency caesarean section in reducing post-operative infectious morbidity. Methodology: The study will be a triple-blind randomised control trial among pregnant women at 28 weeks gestation or more who are booked for emergency caesarean section at Federal Medical Centre, Asaba. One hundred and sixty two women who will meet the inclusion criteria will be randomised into three groups using computer generated random coded numbers into control group with three passes pre-operative vaginal cleansing with placebo and two intervention groups with two passes and three passes of pre-operative vaginal cleansing with 2% Chlorhexidine antiseptic solution prior to emergency caesarean section. Result: The data collected will be analysed using the SPSS version 26 windows. Categorical data will be expressed as absolute numbers and percentages while continuous data will be expressed as mean ± standard deviation. A comparison between the groups using the χ2 (chi-square) test and the Fisher exact test when appropriate will be done while the quantitative variables will be compared by an independent sample t-test. Strength and limitation: The study will be a triple-blind randomised control trial. The randomisation will reduce selection bias by distributing possible potential confounders equally between the three groups for proper comparison. The blinding will minimize the influence of the managing team and research team, participan
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2023
Actual trial start date 29/05/2023
Anticipated date of last follow up 29/05/2023
Actual Last follow-up date 30/11/2023
Anticipated target sample size (number of participants) 162
Actual target sample size (number of participants) 162
Recruitment status Not yet 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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Preoperative vaginal cleansing with sterile water Three passes of sterile swabs saturated sterile water One minute The vulva will be parted with the gloved thumb and index fingers and then 4x4 inches gauze mounted on sponge holding forceps fully saturated with sterile water will be introduced down to the vaginal apex. This will be used to cleanse the vaginal walls and the cervix starting from the fornices to the vaginal introitus in a spiral manner. The procedure will be repeated with the second and third mounted saturated 4x4 gauze. The pre-operative vaginal cleansing procedure will be done within 1 minute. 54 Placebo
Experimental Group Two passes of preoperative vaginal cleansing Two passes of 2% chlorhexidine gluconate solution One minute The vulva will be parted with the gloved thumb and index fingers and then 4x4 inches gauze mounted on sponge holding forceps fully saturated with 2% Chlorhexidine gluconate solution will be introduced down to the vaginal apex. This will be used to cleanse the vaginal walls and the cervix starting from the fornices to the vaginal introitus in a spiral manner. The procedure will be repeated with the second mounted saturated 4x4 gauze. The pre-operative vaginal cleansing procedure will be done within 1 minute 54
Experimental Group Three passes of preoperative vaginal cleansing Three passes of 2% chlorhexidine gluconate solution one minute The vulva will be parted with the gloved thumb and index fingers and then 4x4 inches gauze mounted on sponge holding forceps fully saturated with 2% Chlorhexidine gluconate solution will be introduced down to the vaginal apex. This will be used to cleanse the vaginal walls and the cervix starting from the fornices to the vaginal introitus in a spiral manner. The procedure will be repeated with the second and third mounted saturated 4x4 gauze according to the allocation group. The pre-operative vaginal cleansing procedure will be done within 1 minute 54
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria Pregnant women at 28 weeks gestational age or more with indications for emergency caesarean section who will consent to the study will be recruited. Exclusion criteria 1. Placental praevia 2. Clinical chorioamnionitis 3. Allergy or contraindication to Chlorhexidine 4. Allergy or contraindication to Ceftriaxone 5. Cord prolapse 6. Pre-exiting medical conditions such as severe anaemia, uncontrolled DM and HIV with unsuppressed viral load 7. Gestational age < 28 weeks 8. Caesarean hysterectomy 9. Elective caesarean section Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 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 20/12/2022 Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nnebisi road Asaba 320104 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be endometritis At 3rd day postoperative, one week postperative and at two weeks postoperative
Secondary Outcome The secondary outcome measure will be superficial surgical site infection. At 3rd day postoperative, one week postoperative and two weeks postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Nnebisi road Asaba 320104 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ese Adigba Onodjohwoyovwe Nnebisi road Asaba 320104 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ese Adigba Onodjohwoyovwe Nnebisi road Asaba 320104 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ese Adigba Onodjohwoyovwe adigbaese@gmail.com 234868115905 Nnebisi road
City Postal code Country Position/Affiliation
Asaba 320104 Nigeria Senior Registrar Federal Medical Centre Asaba
Role Name Email Phone Street address
Public Enquiries Ese Adigba Onodjohwoyovwe adigbaese@gmail.com 234868115905 Nnebisi road
City Postal code Country Position/Affiliation
Asaba 320104 Nigeria Senior Registrar Federal Medical Centre
Role Name Email Phone Street address
Scientific Enquiries Peter Ndidi Ebeigbe peternebeigbe@gmail.com 2348035649146 Ugbowo road Benin
City Postal code Country Position/Affiliation
Asaba 300283 Nigeria Prof and Chief Consultant Delta State University Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data (IPD) will be shared after deidentification of all collected data Informed Consent Form,Statistical Analysis Plan,Study Protocol July 2024 to November 2024 Open
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