Condition category
Pregnancy and Childbirth
Date applied
19/11/2007
Date assigned
05/12/2007
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sarah Barnett

ORCID ID

Contact details

30 Guilford Street
London
WC1N 1EH
United Kingdom

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

http://www.ich.ucl.ac.uk

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

  1. 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.

Additional files

Editorial Notes