Study that reduced neonatal mortality rates in India wins Trial of the Year award

A study supported by the Health Foundation, to reduce neonatal mortality rates and maternal depression in very poor communities in eastern India, has been awarded Trial of the Year by the Society for Clinical Trials (SCT).

The trial was led by Dr Prasanta Tripathy and Dr Nirmala Nair, both representing the organisation Ekjut, whose mission is to improve maternal and neonatal outcomes in the poorest areas of India in collaboration with the UCL Centre for International Health and Development.

The Ekjut trial in Jharkhand and Orissa earned recognition by the Society as an ‘extraordinary randomised clinical trial, conducted with high quality in a very difficult setting, and achieving dramatic results of great public health importance’.

The investigators successfully evaluated how women’s community groups affected neonatal mortality and maternal depression in intervention areas as compared to areas where no participatory groups were set up. The groups were evaluated using a cluster-randomised controlled trial.

Thirty-six districts were part of the trial which involved using or organising village women’s groups, who engaged in learning and action through play, stories and games. The group discussions and participations helped members begin to identify newborn health problems within the community, and aided them to make decisions about the strategies to use to address the problems, which they then implemented.

The groups were facilitated by women recruited in the local area, non-healthcare professionals who tended to be married, with some schooling, and  respected members of the community.

The trial results were published in The Lancet in March 2010, and showed that after three years of the intervention, neonatal mortality was reduced by 45% and maternal depression by 57%.

Professor Anthony Costello, UCL Institute for Global Health, co-investigator said, ‘The trial was designed as a community effectiveness trial rather than an efficacy trial of a perfectly implemented intervention which would be difficult to scale up in the real and resource-limited world in which these tribal populations live. Such trials are essential in the developing world so that we can really estimate the impact and cost-effectiveness of what we do. We're delighted that it has been recognised in this way.'

The trial was considered by the SCT to fulfil the following criteria:

• It improves the lot of mankind.
• It provides the basis for a substantial, beneficial change in healthcare.
• It reflects expertise in subject matter, excellence in methodology, and concern for study participants.
• It overcomes obstacles in implementation.
• The presentation of its design, execution, and results is a model of clarity and intellectual soundness.

Dr Tripathy will travel from India to present an overview of the trial methods and findings during the SCT’s 2011 Annual Meeting in Canada in May.