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.: PACTR202401789413039 Date of Approval: 23/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects Of Maternal Handwashing On Prevention Of Infectious Diseases Among Neonates In Western Health Region Of The Gambia
Official scientific title Effects Of Maternal Handwashing On Prevention Of Infectious Diseases Among Neonates In Western Health Region Of The Gambia
Brief summary describing the background and objectives of the trial The Gambia has made significant progress in responding to the high neonatal mortality that the country is facing. Despite this important achievement, neonatal mortality especially from infectious origins still remains a challenge in this country. Hence the purpose of this study was to determine the effects of maternal handwashing promotion on the prevention of infectious diseases among neonates in the western health regions of The Gambia
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Acute respiratory tract infection
Purpose of the trial Education /Training
Anticipated trial start date 06/04/2020
Actual trial start date 11/05/2020
Anticipated date of last follow up 10/05/2021
Actual Last follow-up date 30/10/2021
Anticipated target sample size (number of participants) 800
Actual target sample size (number of participants) 800
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 Non-randomised Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health education and practical demonstration of handwashing techniques 3 6 months Deliveries and neonatal care activities were conducted on all the days from Mondays to Sundays in each of the selected health facilities. The researcher’s Intervention (Health education/health talk on knowledge attitude and practice of handwashing with soap and water) was therefore carried out on all the days of the week to enable the required sample size to be collected on time and also to replace those who did not turn up for their second or third visits or those who were not reached on phone or traced at the home addresses given on their enrolment or pre-testing day. All postnatal mothers who either delivered that very day or came to the particular health facility on routine postnatal visits after facility delivery were recruited and included in the study as participants. Three research assistants from each facility were identified and trained to serve as health educators and data collectors. All the research assistants were given 60 minutes training on the structured health education protocol of intervention, teaching and counseling techniques and skills. They were taught how to seek for consent from participants in the intervention groups, followed by how to counsel and educate participants on simple technology, which is low cost and considered a “do it yourself” vaccine such as handwashing with soap at appropriate identified moments. First visit: Postnatal mothers were approached for enrollment from 1-7days of their postnatal period by the research assistant in the labour ward, postnatal ward and infant welfare clinics of BHC facility. A signed or thump printed informed consent was obtained and the study questionnaire and protocols were delivered 1hour after delivery to allow the postnatal mother to rest. On this visit, researchers administered the questionnaire to the mother/caregiver (pre-testing) to identify neonatal care practices and potential risk factors for neonatal morbidity. The questionnaire administered on this visit focused on the delivery of 400
Control Group Placebo on postnatal care protocol 3 6 months This group received similar treatment as the intervention group above except that handwashing with soap counseling, teaching, role plays, poster explanation and the like were not part of the package given to the control group. First visit: The pre-testing was carried out at the identified units by all the research assistants after consent. Postnatal mothers were approached for enrollment from 1-7days of their postnatal period by the research assistant in the labour ward, postnatal ward and infant welfare clinics of FKHC facility. A signed informed consent was obtained and the study questionnaire and protocols were delivered 1hour after delivery to allow the postnatal mother rest. On this visit, researchers administered the questionnaire to the mother/caregiver (pre-testing) to identify neonatal care practices and potential risk factors for neonatal morbidity. The questionnaire administered on this visit focused on the delivery of the newborn and immediate newborn care practices or determine the information from the antenatal or infant welfare card. Gestational age was estimated as time since the last menstrual period, based on maternal report at enrolment and on Day 1 visit. The knowledge, attitude, practice and neonatal infections prevention practices were determined. They were then each given a 45 minutes face to face lecture, discussion and explanation on the regular postnatal care protocol which include; general care of both the mother and her baby as well as danger signs in the postnatal period. Special mention was made for supporting women who has depression. There was practice of the skills of facilitating family and group support and respecting the concerns of women. Birth spacing, immunization, nutrition and postpartum family planning and breastfeeding for the mother and her family were also discussed after the pre-test. This was done individually or in groups depending on the number and availability of deliveries each day at a comfortable room provided 400 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants were postnatal mothers who have neonates 0-28 days old Either in the neonatal ward or were attending infant welfare clinics in Brikama Health Center and Faji Kunda health facilities respectively. Mothers who are living within the catchment areas of western health regions one and two that are covered by these two facilities. All mothers (prim gravida, multi gravida and of any social background) with normal neonates were qualified to be enrolled in this study. Postnatal mothers who were excluded from this study were those who met the inclusion criteria but unfortunately have sick neonates. Also postnatal mothers with neonates who had genetics/congenital malformation conditions were also not included in this study. Adult: 19 Year-44 Year,New born: 0 Day-1 Month 15 Day(s) 49 Week(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 28/06/2018 The Gambia Government and MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Fajara Banjul 273 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge and practice of handwashing among mothers and neonatal infections during the pretest Day 1 of enrollment
Secondary Outcome prevention of infectious diseases among neonates 4 weeks
Primary Outcome Maternal hand washing practice 2 weeks after the first intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Brikama Major Health Center Brikama Market Brikama Gambia
Faji Kunda Health Center Faji Kunda Kanifing Municipality Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded No. 2 Marina Parade Banjul 1646 Gambia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Haddy Tunkara Bah and Omar Manjang No. 2 Marina Parade Banjul Gambia Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Florence Adeyemo University of Benin Benin City Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omar Manjang manjangomar46@gmail.com 002207577844 No. 2 Marina Parade
City Postal code Country Position/Affiliation
Banjul Gambia Director of Nursing and Midwifery Services Ministry of Health
Role Name Email Phone Street address
Public Enquiries Haddy Tunkara Bah htbah@utg.edu.gm 002203850309 No. 2 Marina Parade
City Postal code Country Position/Affiliation
Banjul Gambia Senior Lecturer University of The Gambia
Role Name Email Phone Street address
Scientific Enquiries Haddy Tunkara Bah htbah@utg.edu.gm 002203850309 Marina Parade
City Postal code Country Position/Affiliation
Banjul Gambia Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) Sharing Statement Title of the Study: Effects of maternal hand washing on prevention of infectious diseases among neonates in Western Health region of The Gambia Objective: the purpose of this study was to determine the effects of maternal hand washing promotion on the prevention of infectious diseases among neonates in the western health regions of The Gambia. Data Sharing Commitment: We are committed to promoting transparency, scientific rigor, and collaboration by sharing individual participant data (IPD) with qualified researchers for the purpose of advancing scientific knowledge and public health. The sharing of IPD aligns with our dedication to fostering open science and ensuring the responsible use of research data. Data Access Policy: Access to the individual participant data will be granted to researchers who submit a formal request, detailing the purpose, methods, and ethical considerations of their proposed analysis. All requests will be subject to review by our Principal Investigator to ensure compliance with ethical standards and participant confidentiality. Data Anonymization and Privacy Protection: To safeguard participant privacy, all shared data will be anonymized and stripped of any personally identifiable information. Publication and Authorship: We encourage and support collaborative efforts in the analysis and publication of results derived from shared data. Researchers utilizing the shared IPD are expected to acknowledge the source of the data appropriately and include representatives of the original study team as collaborators when applicable. Timeline for Data Sharing: The IPD will be made available for sharing within six months of after publication of primary results. How to Request Access: Researchers interested in accessing the individual participant data may submit their requests to the Principal Investigator using the email address: manjangomar46@gmail.com. The request should include a detailed proposal. Statistical Analysis Plan,Study Protocol Within 6 months after publishing primary results Researchers interested in accessing the individual participant data may submit their requests to the Principal Investigator using the email address: manjangomar46@gmail.com. The request should include a detailed proposal, specifying the research questions, analysis plan, and intended use of the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 05/01/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 18/01/2024 Result - 18/01/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information