BabyGel Pilot: the provision of alcohol handgel to postpartum mothers in Mbale, Eastern Uganda to prevent neonatal infective morbidity in the home.

• Register: ISRCTN
• Last refreshed on: 8 May 2023
• Main ID: ISRCTN67852437
• Date of registration: 18/03/2015
• Prospective Registration: Yes
• Primary sponsor: University of Liverpool
• Public title: BabyGel Pilot: the provision of alcohol handgel to postpartum mothers in Mbale, Eastern Uganda to prevent neonatal infective morbidity in the home.
• Scientific title: BabyGel Pilot: a pilot study of a cluster randomised trial of the provision of alcohol handgel to postpartum mothers in Mbale, Eastern Uganda to prevent neonatal infective morbidity in the home.
• Date of first enrolment: 01/04/2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN67852437
• Study type: Observational
• Study design: An open, 2-arm cluster randomised trial with rural villages as the unit of randomisation in Eastern Uganda. (Prevention)
• Phase: Not Applicable

Countries of recruitment

Uganda, Uruguay

Contacts

• Name: Andrew Weeks

Key inclusion & exclusion criteria

Inclusion criteria: 1. Women with an estimated gestation of over 34 weeks
2. Reside in the participating villages.

The gestation age will be determined by the Last Normal Menstruation period (LNMP), and or Ultra sound scan.
Exclusion criteria: Women will be excluded from the study if they
1. Are temporary resident (visitors) in one of the Mbale villages
2. Plan to relocate to distant places (outside of the Mbale District) within 3 months of childbirth

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Reduction in infant (>3 months) sepsis thereby leading to a possible reduction in infant morbidity and mortality
Infections and Infestations

Intervention(s)

A pilot study of a cluster randomised trial of the provision of alcohol handgel to postpartum mothers to prevent neonatal infective morbidity in the home.
This pilot study (work stream 1) will be used to formally pilot the planned main open, 2-arm cluster randomised controlled trial (RCT) comparing alcohol hand rub with normal care. This pilot is one of 3 studies being conducted in preparation for the main BabyGel cluster RCT, and will take place in 10 villages around Mbale, Uganda. Workstream 1 will assess the feasibility of conducting the main trial. Other workstreams are evaluating the optimal hand rub formulation (workstream 2) and consent procedures (workstream 3).

The study will be a 3-way, blinded, randomised cross-over study. Forty postnatal women with children aged under 3 months of age will be recruited through the infant vaccination clinics in two local health centres. The only exclusion will be of those who currently use antiseptic hand wash at home and wish to continue its use. The study will be explained to the women at the clinic and they will be given or read a participant information sheet, which will be translated into the local languages. Those who wish to participate will be asked to provide signed consent.

Participants will be randomly allocated to receive one of 3 different alcohol handrubs in a predetermined order. Each participant will use the allocated handrub for 5 consecutive days followed by a 2-day ‘washout’ period in which they will not use any handrub. At the end of each week they will be asked to return to the health centre to complete evaluation forms and to receive the next pack of handrub. Those who do not attend the follow-up will be contacted by telephone and alternative way of follow-up with the research staff arranged (on an alt

Primary Outcome(s)

1. Infant sepsis (using the Young Infant Clinical Signs Study Group (YICSSG) criteria
2. Sepsis death in the first 90 days of life (assessed using verbal autopsy)

Secondary Outcome(s)

Neonatal: Physician diagnosed infant infection, Microbiologically confirmed infant infection rate in the first 90 days of life (blood culture and cerebrospinal fluid), Infant mortality at 24hrs, 7 days, 4 weeks, and 3 months of life, Individual infant infections, General: fever, clinical jaundice, Infant weight and height at 3 months
Maternal: Gel Hand hygiene compliance, frequency of other hand washing; Maternal postnatal pelvic infection, other infections and satisfaction.

Secondary ID(s)

1.9

Source(s) of Monetary Support

Medical Research Council

Ethics review

Status:
Approval date:
Contact:

1. University of Liverpool Ethics Committee 2. Mbale Regional Hospital Institutional Review Committee (MRHIRC)

Results

• Results available: Yes
• Date Completed: 28/02/2016