The Babygel Study is a cluster-controlled trial examining the impact of improving hand hygiene in rural Ugandan households using locally-produced alcohol-based hand gel.
It will recruit 6000 participants from hard-to-reach communities in 72 villages in the Mbale and Budaka Districts of Eastern Uganda. In these villages, women will be given a birth Kit and half will be given BabyGel after delivery.
The gel is made locally in Uganda from sugar cane and, if the trial proves successful, it could be included in delivery packs for every expectant mother.
The study’s primary outcome measure will be severe infant illness or death in the first 90 days of life. We are planning to open the trial to recruitment in April 2020.
Study Title
A cluster randomised trial to evaluate the effectiveness of household alcohol-based handrub for the prevention of sepsis, diarrhoea and pneumonia in Ugandan infants
Link to the Pilot trial at http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN67852437
Study Design
2-arm cluster randomised trial with rural villages as units of randomisation.
Study Participants
Women who have reached 34 weeks of gestation and their babies (once born) living in villages in Mbale and Budaka District, Eastern Uganda.
Sample Size
5932 women
Planned Study Period
This study is funded for a period of 60 months commencing 1st February 2019 – 31st January 2024.
Planned Recruitment period
The recruitment period is planned for 26 months with a projected commencement date of the beginning of April 2010.
Objectives
Primary
The principal objective of this study is to determine whether the provision of alcohol-based hand rub (ABHR) to pregnant women for postnatal household use is effective for the prevention of severe illness or death during the first 3 months of life. Over 60 months, an open, 2-arm cluster randomised trial with rural villages as units of randomisation will be conducted in which pregnant women will be recruited from homes within 72 study villages in Mbale region, Eastern Uganda.
Partners
Liverpool school of tropical medicine & University Of Exeter
Funders
Sponsors
