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.: PACTR202112553386036 Date of Approval: 01/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Povidone Iodine vaginal cleansing trial
Official scientific title Preoperative versus Postoperative Vaginal Cleansing with Povidone-Iodine and Postoperative Infectious Morbidity: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial BACKGROUND: Maternal infectious morbidity is a common complication of caesarean section and is the third leading cause of maternal mortality in Nigeria. Post-caesarean maternal infectious morbidity is still a big challenge despite prophylactic antibiotics use and other modalities adopted to prevent it. Recently, preoperative vaginal cleansing with Povidone-iodine was recommended in reduction of post-caesarean endometritis by the World Health Organization but its practice is not yet popular in Nigeria. It is however not known if vaginal cleansing with povidone-iodine immediately after caesarean delivery while patient is still in theatre under anaesthesia, will have any effect on post-caesarean maternal infectious morbidity. AIM: To compare the effectiveness of preoperative versus postoperative vaginal cleansing with Povidone-iodine in reducing post-caesarean maternal infectious morbidities at the Alex-Ekwueme Federal University Teaching Hospital Abakaliki
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PVC trial
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Postoperative infectious morbidity
Purpose of the trial Prevention
Anticipated trial start date 24/09/2019
Actual trial start date 02/10/2019
Anticipated date of last follow up 28/05/2020
Actual Last follow-up date 02/06/2020
Anticipated target sample size (number of participants) 480
Actual target sample size (number of participants) 244
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 Postoperative vaginal cleansing group 2 pieces of 4x4cm gauze soaked in povidone iodine is used to cleanse the vagina for 30 seconds starting from the vault. 30 secods Immediately after the surgery while patient is still under anaesthesia, the vagina is evacuated of blood clots and thereafter gauze is soaked in povidone iodine and used to cleanse the vagina twice for 30 seconds each starting from the vault to other vaginal parts 122
Control Group Preoperative vaginal cleansing 2 pieces of 4x4cm gauze held with sponge holding forceps is soaked in povidone iodine and used to cleanse the vagina for 30 seconds starting from the vault. 30 seconds Immediately after administration of spinal anaethesia, with the help of assistants, the vaginal is cleansed with gauze soaked with povidone iodine twice. Thereafter routine abdominal surgical preparation is performed 122 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consented parturient Undergoing elective or emergency caesarean section After the age of fetal viability (≥ 28weeks gestational age). Refusal of consent. Women with known allergy to topical Povidone-iodine or on treatment with iodine or radiotherapy Placenta praevia. Cord prolapse Face presentation with ruptured membranes to avoid contact of fetal face with iodine. Ruptured uterus Thyroid disorders Adult: 19 Year-44 Year 18 Year(s) 44 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 20/07/2019 Research and Ethics Committee AEFUTHA
Ethics Committee Address
Street address City Postal code Country
NO 1 AEFUTHA road Abakaliki 480101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was post caesarean endometritis 12 hourly till discharge
Secondary Outcome Post-caesarean wound infection Postoperative fever Duration of hospitalisation due to infectious morbidity. Adverse reaction to povidone iodine 12 hourly till discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and Gynaecology Alex Ekwueme Federal University Teaching Hospital Abakaliki NO 1 AEFUTHA road Abakaliki 480101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ugadu Ikechukwu No 1 AEFUTHA Road Abakaliki 480101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor John Okafor Egede Plot 108 Nkaliki GRA Abakaliki 48010 Nigeria Individual
Secondary Sponsor Ikechukwu O Ugadu No 1 AEFUTHA road Abakaliki 480101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ikechukwu Ogwudu Ugadu ugaduike@gmail.com +2347032339988 No 1 AEFUTHA road
City Postal code Country Position/Affiliation
Abakaliki 480101 Nigeria Consultant Alex Ekwueme Federal University teaching Hospital Abakaliki
Role Name Email Phone Street address
Scientific Enquiries John Okafor Egede egedejohno@gmail.com +2348037797950 Plot 108 Nkaliki GRA
City Postal code Country Position/Affiliation
Abakaliki 480101 Nigeria Consultant Obstetrician Gynaecologist AEFUTHA
Role Name Email Phone Street address
Public Enquiries Ikechukwu O. Ugadu ugaduike@gmail.com +2347032339988 No 1 AEFUTHA road
City Postal code Country Position/Affiliation
Abakaliki 480101 Nigeria Consultant AEFUTHA
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data collected during trial can be shared after de-identification. Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, no end date Open Access. Any one can make the requests and should send for permission to ugaduike@gmail.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 23/11/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 23/11/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information