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.: PACTR201709002597110 Date of Approval: 08/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Preoperative Vaginal Cleansing with Povidone-Iodine in Post-ceasarean Infectious Morbidity; A Randomized Controlled Trial.
Official scientific title Effectiveness of Preoperative Vaginal Cleansing with Povidone-Iodine in Post-ceasarean Infectious Morbidity; A Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Background: Globally, caesarean section is the commonest major surgical procedure performed by obstetricians. However caesarean section is associated with infectious morbidity. Pre-operative vaginal cleansing with povidone-iodine may reduce the infectious morbidity. Aim: To determine the effectiveness of preoperative vaginal cleansing with povidone-iodine in reducing post-caesarean maternal infectious morbidities. Methodology: This will be a randomized controlled trial in which consented pregnant women booked for caesarean section will be randomized into 2 groups. Group 1 women will receive preoperative vaginal cleansing with povidone-iodine prior to caesarean section while group 2 women will not. After caesarean section , there will be daily check of clinical parameters of the 2 groups of women such as temperature, abdominal tenderness, rate of uterine involution and foul smelling vaginal discharge. Urine microscopy, culture and sensitivity and malarial parasitaema will be done on the participants who have fever to rule out urinary tract infection and malaria. Wound swab for microscopy ,culture and sensitivity, if there is wound dehiscence, and endo-cervical swab for microscopy, culture and sensitivity will be done on all the participants who have fever, marked abdominal tenderness, uterine sub-involution and foul smelling vaginal discharge to determine the cause of the infection.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Post-operative caesarean infectious morbidity,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/12/2017
Actual trial start date 01/12/2017
Anticipated date of last follow up 30/06/2018
Actual Last follow-up date 30/06/2018
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 180
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group preoperative vaginal cleansing with povidone-iodine 50 mllliliters of povidone-iodine per patient 30 seconds Vaginal cleansing 90 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting parturients admitted in FETHA for either elective or emergency caesarean section after 37 completed weeks. Refusal of consent. Women with known allergy to topical povidone-iodine Placenta praevia. Cord prolapse Clinical Chorioamnionitis Foul smelling discharge on admission. Women with immunosupression due to HIV/AIDS, Diabetes Miletus or chronic use of steroids. 18 Year(s) 40 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
No 30/09/2017 Research and Ethics Committee of Federal Teaching Hospital,Abakaliki
Ethics Committee Address
Street address City Postal code Country
Federal Teaching Hospital, Abakaliki PMB 102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post caesarean endometritis Hospital stay duration by the patients
Secondary Outcome ¿ post caesarean wound infection ¿ Post operative fever ¿ Wound breakdown. ¿ Duration of hospitalization. Hospital stay duration by the patients
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Teaching Hospital Hospital street Abakaliki PMB 102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
The authors' contribution Federal Teaching Hospital, Abakaliki PMB 102 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The authors Federal Teaching Hospital, Abakaliki PMB 102 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Ikechukwu Ogudu Ugadu Federal Teaching Hospital, Abakaliki PMB 102 Nigeria
Dr Leonard Ogbonna Ajah Faculty of Medical Sciences,University of Nigeria,Ituku-Ozalla,Enugu. Enugu 40001 Nigeria
Dr I.B.O Dimejesi Federal Teaching Hospital, Abakaliki PMB 102 Nigeria
Prof. Benjamin Chukwuma Ozumba Faculty of Medical Sciences,University of Nigeria,Ituku-Ozalla,Enugu. Enugu 40001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ikechukwu Ugadu ugaduike@gmail.com +2348032339988 Federal Teaching Hospital,
City Postal code Country Position/Affiliation
Abakaliki PMB 102 Nigeria Senior Registrar
Role Name Email Phone Street address
Principal Investigator Leonard Ajah leonard.ajah@unn.edu.ng +2348033920789 Faculty of Medical Sciences,University of Nigeria,Ituku-zalla,
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Senior Lecturer
Role Name Email Phone Street address
Principal Investigator Benjamin Ozumba benjamin.ozumba@unn.edu.ng +2348060819600 Faculty of Medical Sciences,University of Nigeria,Ituku-zalla,
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Professor
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information