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.: PACTR201808694484456 Date of Approval: 29/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Integrating chlorohexidine 7.1% into safe delivery kit in Republic of South Sudan: A low cost intervention to reduce neonatal mortality in rural community setting
Official scientific title Integrating chlorohexidine 7.1% into safe delivery kit in Republic of South Sudan: A low cost intervention to reduce neonatal mortality in rural community setting
Brief summary describing the background and objectives of the trial According to the 2016 WHO report, the neonatal mortality rate (NMR) in South Sudan is 38% deaths per 1,000 live births with annual reduction in newborn mortality rate of 2.6% (2000-2016). Neonatal mortality accounts for 43% of under-five mortality in south Sudan and infection (Tetanus sepsis and meningitis) is estimated to be responsible for 20% or more of neonatal deaths. Since much of South Sudan’s population is widely dispersed in rural areas of the country, a substantial proportion of deliveries occur in the home with the assistance of community health workers (CHWs) and traditional birth attendants (TBA). Only 19% of the birth occur at health facility in South Sudan Given its relatively high Neonatal Mortality Rate, large numbers of home based deliveries, rural population, and the existence of an intact system of TBAs (though largely untrained), rural part of South Sudan is the ideal location for conducting the proposed study. The effectiveness of integrating or providing chlorohexidine with safe delivery kit for cord care will be piloted in one of the County of South Sudan with high home birth. Chlorohexidine gel or solution for cord care has not been known to have been used for cord care before in republic of South Sudan and it is not in the MOH approved essential list for either health facility use or community health workers kit. Thus it will required approval for use for topical disinfection of the newborn cord
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/08/2018
Actual trial start date 30/04/2019
Anticipated date of last follow up 30/04/2019
Actual Last follow-up date 30/04/2019
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants) 600
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
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Quasi Exprimental Study 6 months Chlorohexidine will be applied daily to the umbilical cord beginning immediately after birth and within 24 hours of birth until three days after the cord detaches. 300
Control Group Quasi Exprimental Study 6 months Dry cord care consists of wiping the cord clean with a clean dry cloth and leaving the umbilical stump uncovered until it falls off in accordance with South Sudan MoH guidelines. 300 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Pregnant women in the 2nd or 3rd trimester • Age 15 years and above • Pregnant women with plans to stay in the study area (catchment area of the health facility) for delivery and one month post-partum • Willingness to provide cord care as per the protocol • Willingness to provide informed consent • Pregnant women in the 1st trimester • Pregnant women delivered at health facility and one month post-partum • refused to provide informed consent New born: 0 Day-1 Month 0 Day(s) 28 Day(s) Both
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 22/05/2018 Ministry of Health ethical comimitte
Ethics Committee Address
Street address City Postal code Country
Ministerial Complex , Juba South Sudan Juba 00211 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome • To determine whether 4% chlorohexidine cord cleansing integrated with safe delivery Kit is more effective than dry cord care for the prevention of cord infections • To train 100 TBAs/Community Health Workers on the application of CHX and how to train mothers on the continued application • To determine if neonatal cord sepsis in the intervention group will reduce by 75% compared to the control group At the end of intervention
Primary Outcome Develop and test a system to integrate 7.1% chlorohexidine (CHX) into safe delivery kits and distribute though traditional birth attendants (TBAs) to prevent neonatal cord infections that result from rural home births in South Sudan. At the initail phase
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gurei Lalogo Gumbo Mahad Juba South Sudan Jubek state 00211 Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada Mars Center West Tower, 661 University Avenue Suite 1720 Toronto 0001 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Grand Challnges Canada MaRs center , West Tower, 661 University Avenue suite 1720, Toronto Ontario Toronto 0001 Canada Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Ministry of health Minsterial Complex , Juba , South Sudan Juba 00211 Sudan
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Christopher Vunni chrissvunni@gmail.com 00256786224828 3rd Floor MCC building, Unity Road, Nimira Talata Juba, South Sudan
City Postal code Country Position/Affiliation
Juba 00211 Sudan Executive Director
Role Name Email Phone Street address
Scientific Enquiries Judith Draleru judyajua@gmail.com 0025677330701 3rd Floor MCC building, Unity Road, Nimira Talata Juba, South Sudan
City Postal code Country Position/Affiliation
Juba 00211 Sudan Project co Lead
Role Name Email Phone Street address
Public Enquiries Joyce Sitima sitimajoyce10@gmail.com 00211922428649 3rd Floor MCC building, Unity Road, Nimira Talata Juba, South Sudan
City Postal code Country Position/Affiliation
Juba 00211 Sudan Research Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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