Condition category
Pregnancy and Childbirth
Date applied
27/02/2009
Date assigned
06/04/2009
Last edited
27/04/2010
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

Prof Anthony Costello

ORCID ID

Contact details

University College London (UCL) Institute of Child Health
Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2883
a.costello@ich.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Improving maternal and newborn health through participatory community groups in three rural districts in Bangladesh: a cluster randomised controlled trial

Acronym

BADAS (Perinatal Care Project)

Study hypothesis

Will a community mobilisation intervention improve maternal and neonatal home care, service uptake, morbidity and mortality in three rural districts in Bangladesh?

Ethics approval

Not provided at the time of registration

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

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 a month 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 1st February 2005 until the end of the trial (31 December 2007).

Secondary outcome measures

1. Maternal and neonatal home care practices
2. Utilisation of antenatal, delivery and postnatal services

All outcomes measured prospectively from 1st February 2005 until the end of the trial (31 December 2007).

Overall trial start date

01/02/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Women (no defined age range) who reside in 18 communities during the study period.

Participant type

Patient

Age group

Other

Gender

Female

Target number of participants

2000 women group members

Participant exclusion criteria

1. Women who decline to be interviewed or reside outside the study area
2. Women residing in a Tea Estate

Recruitment start date

01/02/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Bangladesh

Trial participating centre

University College London (UCL) Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

University College London (UCL) Institute of Child Health (UK)

Sponsor details

Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2883
a.costello@ich.ucl.ac.uk

Sponsor type

Research organisation

Website

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

Funders

Funder type

Research organisation

Funder name

Department for International Development (DFID) (UK) (ref: RPC HD5)

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/20207412

Publication citations

  1. Results

    Azad K, Barnett S, Banerjee B, Shaha S, Khan K, Rego AR, Barua S, Flatman D, Pagel C, Prost A, Ellis M, Costello A, Effect of scaling up women's groups on birth outcomes in three rural districts in Bangladesh: a cluster-randomised controlled trial., Lancet, 2010, 375, 9721, 1193-1202, doi: 10.1016/S0140-6736(10)60142-0.

Additional files

Editorial Notes