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.: PACTR202308561344907 Date of Registration: 03/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Peri-operative vaginal cleansing using 4% chlorhexidine versus 10% povidone-iodine solution to prevent post-caesarean endometritis in Ilorin: A randomized controlled study
Official scientific title Peri-operative vaginal cleansing using 4% chlorhexidine versus 10% povidone-iodine solution to prevent post-caesarean endometritis in Ilorin: A randomized controlled study
Brief summary describing the background and objectives of the trial Background: Caesarean section (CS) is one of the commonest obstetric procedures and the rate is increasing globally. In spite of improvements in surgical techniques and use of broad spectrum antibiotics, infectious morbidity such as endometritis remains a major concern. Puerperal sepsis remains a major cause of maternal morbidity and mortality especially in Nigeria. Endometritis has been reported to be about 10 times more common after CS compared to vaginal delivery. Therefore, complimenting prophylactic antibiotics use with simple, easy, inexpensive, effective and reproducible method to reduce the occurrence and attendant complications of endometritis will be of immense additional benefit to maternity services. Objective: The study seeks to determine the effect of peri-operative vaginal cleansing on the occurrence of post-caesarean endometritis using 4% chlorhexidine compared to 10% povidone-iodine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Endometritis ,Peuperial infection
Purpose of the trial Prevention
Anticipated trial start date 06/02/2023
Actual trial start date 09/03/2023
Anticipated date of last follow up 29/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group chlorhexidine Participants will be placed in dorsal position and an indwelling two-way urethral catheter will be passed and retained under aseptic technique using the same antiseptic agent to be used for vaginal cleansing. The vaginal cleansing will be done by the trained research assistant after scrubbed for the surgery, both patients and surgeon and or researcher will be blinded to the type of cleansing agents used as both agents will be same colour, after placed in dorsal position, with labia parted with non-dominant hand. Participants randomized will have vaginal cleansing using three pieces of sterile gauze obtained from hospital Central Sterile Supply Department (CSSD), fully soaked in a sterile bowl with least numbered cleansing agent bottle, folded and grasped with sterile sponge holding forceps to clean the vagina from the apex to the introitus with attention to the anterior, posterior and lateral vaginal walls as well as the fornices. Each sponge will be rotated 360° in the vagina and the entire process will last about 20 seconds and will be repeated thrice. The same procedure will be carried out for subsequent randomized patients. 60 seconds Antiseptic and Antimicrobial 68
Control Group Povidoneiodine Participants will be placed in dorsal position and an indwelling two-way urethral catheter will be passed and retained under aseptic technique using the same antiseptic agent to be used for vaginal cleansing. The vaginal cleansing will be done by the trained research assistant after scrubbed for the surgery, both patients and surgeon and or researcher will be blinded to the type of cleansing agents used as both agents will be same colour, after placed in dorsal position, with labia parted with non-dominant hand. Participants randomized will have vaginal cleansing using three pieces of sterile gauze obtained from hospital Central Sterile Supply Department (CSSD), fully soaked in a sterile bowl with least numbered cleansing agent bottle, folded and grasped with sterile sponge holding forceps to clean the vagina from the apex to the introitus with attention to the anterior, posterior and lateral vaginal walls as well as the fornices. Each sponge will be rotated 360° in the vagina and the entire process will last about 20 seconds and will be repeated thrice. The same procedure will be carried out for subsequent randomized patients. 60 seconds Antiseptic and Antimicrobial 68 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women aged ≥18 years scheduled for non-elective CS irrespective of the booking status. Live intrauterine fetus (es). Consent to participate in the study Active genital warts. Women with antepartum haemorrhage or an ongoing episode of vaginal bleeding. Reported allergy to chlorhexidine and / or iodine containing solution. Women previously on antibiotic therapy for more than 24hours before surgery irrespective of the indication. Women with fetus (es) with face presentation. Women with clinical diagnosis of chorioamionitis.. Women with diagnosed thyroid disorders or goitre on examination. Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
Women aged ≥18 years scheduled for non-elective CS irrespective of the booking status. Live intrauterine fetus (es). Consent to participate in the study Active genital warts. Women with antepartum haemorrhage or an ongoing episode of vaginal bleeding. Reported allergy to chlorhexidine and / or iodine containing solution. Women previously on antibiotic therapy for more than 24hours before surgery irrespective of the indication. Women with fetus (es) with face presentation. Women with clinical diagnosis of chorioamionitis.. Women with diagnosed thyroid disorders or goitre on examination. Adult: 19 Year-44 Year 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 28/10/2022 University of ilorin ethical review committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road, oke oyi, Ilorin East PMB 1459 Ilorin East 240101 Nigeria
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 28/10/2022 Evidence of application for ethical approval
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road. PMB 1459 Ilorin East 240101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of this study will be the incidence of endometritis (both clinical and laboratory) for women who had vaginal cleansing with 4% Chlorhexidine (experiment group) and 10% PVP-I (control). From 24 hrs post operation till 14 days post op
Secondary Outcome secondary outcomes to be measured for the study are: Presence of adverse reaction to the vaginal cleansing agent (vaginal dryness, burning sensation, vaginal itching, vulva rashes, vulva swelling, and vulva pain). Clinical evidence of post-operative wound infection. Relationship between risk factors for endometritis and occurrence of endometritis. Neonatal outcomes especially first and fifth-minute APGAR scores as well as admission into Neonatal intensive care unit (NICU). From time of intervention till 14 days post operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital Old Jebba Road, Oke Oyi. PMB 1459 Ilorin East 240101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal University of ilorin Teaching Hospital. Obstetrics and Gynecological dept Ilorin East 240101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self University of ilorin Teaching Hospital Ilorin East 140101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nasiru IBRAHIM nasiruibrahim424@gmail.com +2347037957122 University of ilorin Teaching Hospital. Obstetrics and Gynecological dept
City Postal code Country Position/Affiliation
Ilorin East 240101 Nigeria Senior Resident
Role Name Email Phone Street address
Public Enquiries Nasiru IBRAHIM nasiruibrahim424@gmail.com +2347037957122 University of ilorin Teaching Hospital. Obstetrics and Gynecological dept
City Postal code Country Position/Affiliation
Ilorin East 240101 Nigeria Senior Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Nasiru IBRAHIM nasiruibrahim424@gmail.com +2347037957122 University of ilorin Teaching Hospital. Obstetrics and Gynecological dept
City Postal code Country Position/Affiliation
Ilorin East 240101 Nigeria Senior Resident Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data collected during the study after the deidentification, will be shared, including the protocol, statistical analysis plan, informed consent, and analtic code. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be available 12 months after publication and will end after 7 years of publication The data will be shared with the researchers who have ethical approval for the proposed study.Also the data requestor has signed a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
The proposal should be directed to nasiruibrahim424@gmail.com 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