Improving maternal and newborn health in rural areas of Jharkhand and Orissa through the empowerment of tribal communities

ISRCTN	ISRCTN21817853
DOI	https://doi.org/10.1186/ISRCTN21817853
Protocol serial number	03PC03
Sponsor	The Institute of Child Health (UK)
Funders	The Health Foundation (UK) (ref: 1748/3001), The Department For International Development (DFID) (UK) (ref: HPD KP 14)

Submission date: 19/11/2007
Registration date: 05/12/2007
Last edited: 10/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sarah Barnett
Scientific

30 Guilford Street
London
WC1N 1EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from an Independant Ethics Committee (chaired by Dr A.K. Debdas), 14/06/2005.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Neonatal and maternal mortality rates, measured prospectively from 01/08/2005 until the end of the trial (likely to be February 2008).
Key secondary outcome measure(s)	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).
Completion date	01/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	9000
Key inclusion criteria	Women (no defined age range) who reside in 36 predominantly tribal communities during the study period
Key exclusion criteria	Women who decline to be interviewed or reside outside the study area
Date of first enrolment	01/08/2005
Date of final enrolment	01/02/2008

Locations

Countries of recruitment

United Kingdom
England
India

Study participating centre

30 Guilford Street

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/04/2010		Yes	No