Pilot study: a cluster randomised trial of the provision of alcohol handgel to postpartum mothers to prevent neonatal infective morbidity in the home

The research question is "Is the provision of alcohol hand gel to pregnant women in rural Uganda a clinically and cost-effective way of preventing early infant infections?". To provide context to this question across the globe, there are an estimated 3 million neonatal deaths annually. In Uganda, with over 1.5 million live births annually, 142,000 newborn infants die every year before reaching their fifth year with 33% of these in the neonatal period. This places Uganda 153rd out of 163 countries in the global rank for frequency of neonatal deaths. Most newborn infections and deaths occur in the community, and are frequently unreported to the health sector. For example, preliminary findings from the Iganga/Mayuge Demographic Surveillance Site showed that 60% of all deaths occur outside a health facility setting and go unreported. African community studies suggest an infection rate of around 30%.

In terms of infection prevention hand washing with soap even when washed with unclean water results in a large reduction in hand contamination. A recent systematic review concluded that there was a lack quality evidence for the effect of clean birth and postnatal newborn care practices on neonatal mortality. However, the need for clean birth and postnatal care is widely accepted. A Delphi expert consensus process judged that clean birth practices at home with no skilled attendant could reduce neonatal sepsis deaths by 15% and tetanus deaths by 30%. The panel judged that postnatal newborn care practices could prevent 40% of neonatal sepsis deaths, but that more research is needed particularly on the content and quality of care during the early postnatal period.

A research priority-setting exercise by World Health Organisation (WHO) on the reduction of newborn infection deaths found that the top ranked question was 'what is the feasibility, effectiveness, and cost of different approaches to promote the home care practices especially hand washing of caregivers?' Despite this being 4 years ago, there are no registered studies addressing the use of alcohol hand gels for mothers in the neonatal period, and local experts know of no similar study. The importance of hand-washing in preventing infective deaths has led WHO to develop guidelines for hand hygiene both within health care settings and in the community and integrate hand hygiene into neonatal community care programmes. For hand hygiene, the current recommended practice at the household level is handwashing with soap. However, studies show widespread non-adherence to the household guidelines, often due to a lack of water. An alternative option could therefore be alcohol based hand gel. This is cheap ($0.6 for 60mls) and active against a broad range of Gram-positive and Gram-negative aerobic bacteria, including staphylococci, streptococci, and enteric Gram-negative bacteria. Although alcohol-based hand rubs effectively prevent acute diarrhoeal diseases.

A pilot of the full study will be conducted in 10 villages around Busiu Health Centre IV and Lwangoli Health Centre III in the Mbale District of East Uganda. With an average of 3.5 deliveries per month in the study villages - a 3-month pilot will therefore include around 100 births.

Impact Summary
Study objectives:
1. To determine the effectiveness of providing alcohol hand gel to pregnant women in rural Eastern Uganda as a way of reducing infant infective morbidity in the first 3 months of life
2. To determine the cost-effectiveness of providing alcohol hand gel to pregnant women in rural Eastern Uganda as a way of reducing early infant infections in the first 3 months of life
3. To prevent maternal infection in the first 3 months postnatally


This BabyGel clinical trial will have multiple beneficiaries. Policy-makers nationally and internationally, local government agencies and regulators and the commercial private sector are all likely to benefit from the clinical trial outcomes.

The Department of Women's and Children's Health in the University of Liverpool is a WHO Collaborating Centre and home of the Cochrane Pregnancy and Childbirth Group. Both these facilitate rapid integration of research findings into systematic reviews, as well as having long-established mechanisms for the dissemination of research findings. This will enable the findings to diffuse rapidly to international policy makers.

If the hand-gel is effective at reducing neonatal mortality then we envisage a range of strategies for scale-up including the placement of hand gel into maternal delivery packs, antenatal distribution, postnatal distribution through village health workers, or social marketing with the production of subsidised locally available gels.

Within Uganda itself, the research team includes members of key organisations who need to be aware of the research findings. These include: 1) experienced academic researchers in public health, maternal health and child health; 2) research training institutions (e.g. Makerere and Busitema Universities, Sanyu Africa Research Institute, Mbale Regional Referral Hospital) who will have new teaching and research tools to train researchers; 3) Government of Uganda Ministry of Health; and 3) over 7,000 research participants themselves, who will benefit from this simple self-help technique to improve maternal and neonatal health. The use of hand gel amongst participants will also spread the message directly to neighboring areas about the importance of hand hygiene, thus disseminating the hand hygiene message beyond the immediate study group. This trial will facilitate to reduce health inequity and help to develop sustainable communities throughout Mbale.

The impact summary comprises a range of initiatives aimed at:
1)Dissemination of information and outcomes at a range of levels
2)Research - capacity building
3)Local awareness raising of the importance of hand hygiene
4)Information sharing of individual components of the project

On-going Dissemination of Information and Outcomes
There will be significant opportunities for information sharing and policy transfer throughout the project. The project will be evaluated and the development of the project as a whole and will take place on an on-going basis.