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.: PACTR202201669178899 Date of Approval: 05/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Chlorhexidine vaginal cleansing in reducing postcaesarean surgical site infection and endometritis at two tertiary hospitals in Enugu, Nigeria: a randomized controlled trial
Official scientific title Effectiveness of Chlorhexidine vaginal cleansing in reducing postcaesarean surgical site infection and endometritis at two tertiary hospitals in Enugu, Nigeria: a randomized controlled trial
Brief summary describing the background and objectives of the trial Background:Despite the use of prophylactic antibiotics during caesarean delivery, post-caesarean surgical site infection and endometritis still complicate the puerperal period; leading to significant maternal morbidities, long hospital stay, increased health care spending and poor neonatal care. In low-income countries where resistance to antibiotics has been documented, it has been speculated that the use of vaginal cleansing with chlorhexidine solution would serve as an adjunct to prophylactic antibiotics in reducing the menace of post-caesarean endometritis. Objective: To determine the effectiveness of chlorhexidine vaginal cleansing in reducing post-caesarean delivery endometritis and surgical site infection in UNTH Ituku/Ozalla and ESUTH Parklane, Enugu.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied Post caesarean endometritis and wound infection
Purpose of the trial Vaginal cleansing with chlorhexidine solution versus no cleansing
Anticipated trial start date 03/09/2018
Actual trial start date 03/09/2018
Anticipated date of last follow up 31/05/2019
Actual Last follow-up date 30/06/2019
Anticipated target sample size (number of participants) 510
Actual target sample size (number of participants) 312
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
Experimental Group Chlorhexidine solution 50 ml of chlorhexidine solution used to clean the vagina, once, preoperatively 1min A sterile kidney dish containing 5 pieces of gauze and about 50 ml of 0.2% Chlorhexidine solution and a sterile sponge holder was prepared. The lower third of the vagina was cleansed first using one of the 5-well-soaked (in 0.2% chlorhexidine gluconate solution) sterile gauze, held with the sponge holding forceps. This was followed by cleaning of the anterior, two lateral walls and then posterior wall of the vagina. Each of this vaginal portion was cleansed with one-well chlorhexidine-soaked gauze, starting from the fornix outwards in one-stroke movement. This pattern of cleansing helped to prevent contamination 156
Control Group No vaginal cleansing none none no vaginal cleansing 156 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All pregnant women who had been billed for caesarean delivery either electively or as emergency and given consent at the two Obstetrics units (ANW and Labour wards) of the two study centers were included women with clinical diagnosis of chorioamnionitis women with diagnosis of obstructed labour women with contraindications to caesarean delivery women with contraindication to chlorhexidine use such as history of serious allergic reaction women with premature rupture of membranes, HIV/AIDs, diabetes mellitus and hemoglobin <10g/dl that could not be corrected before surgery Adult: 19 Year-44 Year 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 21/03/2018 University of Nigeria Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ituku/Ozalla Enugu 00004 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of women who received vaginal cleansing with chlorhexidine and had endometritis or surgical site infection or both 3rd day post op, 2 weeks post op and 6 weeks post op
Secondary Outcome proportion of babies admitted into the Newborn Special Care within 72 hours of birth for APGAR Score 7, neonatal sepsis, neonatal jaundice and other causes. Within 72 hours of birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Ituku/Ozalla Enugu Nigeria
Enugu State University of Science and technology Teaching Hospital Parklane, GRA Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Coal City Dissertation Research Grant Award sponsored by Echezona E Ezeanolue and Prof. Chima Onoka in Collaboration with College of Medicine University of Nigeria Nsukka University of Nigeria, Ituku/Ozalla Campus Enugu 00004 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Coal City Dissertation Research Grant Award by Profs Echezona E Ezeanolue and Chima A. Onoka in Collaboration with College of Medicine University of Nigeria Nsukka Ituku/Ozalla Campus Enugu 00004 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Johnpaul Nnagbo jesp7200@yahoo.co.uk +2348066731322 22 Enugu-Agidi Street Achara Layout
City Postal code Country Position/Affiliation
Enugu 00004 Nigeria Department of Obstetrics and Gynaecology University of Nigeria Teaching Hospital Ituku Ozalla Enugu State
Role Name Email Phone Street address
Public Enquiries Johnpaul Nnagbo nnagbo1@gmail.com +2348066731322 22 Enugu Agidi Street Achara Layout
City Postal code Country Position/Affiliation
Enugu 0004 Nigeria Department of Obstetrics and Gynaecology University of Nigeria Teaching Hospital Ituku Ozalla Enugu State
Role Name Email Phone Street address
Scientific Enquiries Johnpaul Nnagbo jesp7200@yahoo.co.uk +2348066731322 22 Enugu Agidi Street Achara Layout
City Postal code Country Position/Affiliation
Enugu 00004 Nigeria Consultant Gynaecologist University of Nigeria Teaching Hospital Ituku Ozalla Enugu State
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participants Data will be made available to anybody wo wishes to have access to them. This will be inform of results that shall be presented in tables and figures Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol This will be from completion of data collection and publication up to 5 years Those wish to enquire about our study protocol
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 03/01/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 03/01/2022 Result - 03/01/2022 Result - 03/01/2022 Result - 03/01/2022 Result - 03/01/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information