Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
03PC03
Study information
Scientific title
Acronym
Study hypothesis
Will a community mobilisation intervention improve maternal and neonatal home care, service uptake, morbidity and mortality and maternal depression in tribal communities in Jharkhand and Orissa, India?
Ethics approval
Ethics approval received from an Independant Ethics Committee (chaired by Dr A.K. Debdas), 14/06/2005.
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Maternal and child health
Intervention
In each intervention cluster a facilitator will convene community groups to explore maternal and neonatal health issues. Groups will meet once or twice monthly and move through action research cycles. The programme inputs can be itemised as:
1. Recruitment, training, supervisions and remuneration of facilitators. The role of the facilitator is to activate and strengthen groups, support them in identifying problems, help to plan possible solutions and support the implementation and monitoring of solution strategies in the community. Although she requires a grasp of health issues and some knowledge of potential interventions, she needs to be a facilitator rather than a teacher. As such, she may act as a broker of information and communication but her prime importance is as a catalyst for community mobilisation
2. Development of tools for conducting group meetings, process evaluation and documentation
3. Recruitment, training, supervision and remuneration of a supervisory cadre to support the community-based facilitators
There is no follow-up period after the intervention ends. The intervention is a community mobilisation intervention, which only occurs in the intervention clusters. All clusters, control and intervention, receive health system strengthening activities.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Neonatal and maternal mortality rates, measured prospectively from 01/08/2005 until the end of the trial (likely to be February 2008).
Secondary outcome measures
1. Maternal and neonatal home care practices
2. Utilisation of antenatal, delivery and postnatal services
3. Maternal depression
All outcomes measured prospectively from 1st August 2005 until the end of the trial (likely to be February 2008).
Overall trial start date
01/08/2005
Overall trial end date
01/02/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Women (no defined age range) who reside in 36 predominantly tribal communities during the study period
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
9000
Participant exclusion criteria
Women who decline to be interviewed or reside outside the study area
Recruitment start date
01/08/2005
Recruitment end date
01/02/2008
Locations
Countries of recruitment
India
Trial participating centre
30 Guilford Street
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
The Institute of Child Health (UK)
Sponsor details
University College London (UCL)
30 Guilford Street
London
WC1N 1EH
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
The Health Foundation (UK) (ref: 1748/3001)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Department For International Development (DFID) (UK) (ref: HPD KP 14)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20207411
Publication citations
-
Results
Tripathy P, Nair N, Barnett S, Mahapatra R, Borghi J, Rath S, Rath S, Gope R, Mahto D, Sinha R, Lakshminarayana R, Patel V, Pagel C, Prost A, Costello A, Effect of a participatory intervention with women's groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster-randomised controlled trial., Lancet, 2010, 375, 9721, 1182-1192, doi: 10.1016/S0140-6736(09)62042-0.