The effect of participatory women’s groups on birth outcomes in Bangladesh: does coverage matter?

ISRCTN ISRCTN01805825
DOI https://doi.org/10.1186/ISRCTN01805825
Secondary identifying numbers 1VTP/07CH05
Submission date
28/04/2011
Registration date
15/06/2011
Last edited
22/05/2013
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

Prof Anthony Costello
Scientific

UCL Institute of Child Health
Centre for International Health and Development
London
WC1N 1EH
United Kingdom

+44 (0)20 7905 2883
a.costello@ich.ucl.ac.uk

Study information

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeScreening
Scientific titleThe effect of participatory women’s groups on birth outcomes in Bangladesh: does coverage matter? A cluster randomised controlled trial
Study acronymPerinatal Care Project (PCP) Diabetic Association of Bangladesh (BADAS)
Study objectivesWe hypothesise that the intervention will lead to a 30% lower neonatal mortality in intervention clusters compared with control clusters, during the last 24 months of the study.
Ethics approval(s)1. UCL Research Ethics Committee approved in March 2008; annually reviewed (ref:ID number: 1488/001)
2. Diabetic Association of Bangladesh Ethical Review Committee approved on 7th July 2010 (but approval was granted before the start of the trial, as part of our ongoing women's group work that had started in 2005)
Health condition(s) or problem(s) studiedMaternal and Child Health
InterventionThe intervention is a participatory learning action cycle with women’s groups. In each intervention cluster, facilitators convene women’s groups that meet on a monthly basis. The participatory learning and action cycle has 4 phases: First, the groups identify and prioritise health problems, then plan strategies to address these problems, subsequently they put these strategies into practice, and finally, they evaluate their strategies.

As we aim to study the effect of an intervention with a high coverage of women’s groups in the population, 648 new groups were formed by newly recruited facilitators and started to meet from January 2009 onwards, in addition to the 162 women’s groups that were already set up in the intervention areas as part of an earlier trial in the same study area. These ‘old’ groups have continued to meet on a monthly basis from late 2004 onwards. The 648 new groups will go through a cycle of monthly meetings on maternal and newborn health (Cycle 1), while from April 2010 the 162 old groups will proceed to a cycle of meetings on under-5 and women’s health (Cycle 2), while periodically continuing to review maternal and newborn health issues. The combined 810 women’s groups constitute a coverage of 1 group per 300 population, in comparison with 1 group per 1414 population in the previous trial.

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 this role requires a grasp of health issues and some knowledge of potential interventions, she needs to be a facilitator rather than a teacher. As such, the facilitator may act as a broker of information and communication but her prime importance is as a catalyst for community mobilisation.

All clusters, control and intervention, receive health system strengthening activities.

Patient information sheets are not used because this was a community trial of a social intervention (i.e. not a clinical trial). The intervention consists of women's groups that discuss and design their own strategies to improve newborn and maternal health. All the women in these women's groups participate voluntarily. At the start of the women's groups, there was extensive discussion of what the aims and structure of the women's groups are. By voluntarily joining a women's group, the participants consent to the intervention (i.e. women's groups). Oral consent was obtained from the respondents in the monitoring and surveillance interviews.
Intervention typeOther
Primary outcome measureNeonatal mortality (deaths in the first 28 complete days after birth per 1,000 live births), during the last 24 months of the study.
Secondary outcome measures1. Early and late neonatal mortality rate
2. Stillbirth rate
3. Pregnancy-related mortality ratio and maternal mortality ratio
4. Health care use
5. Home care practices
Overall study start date01/01/2009
Completion date30/06/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants16,000 births to women using the above in/exclusion criteria, during the last 24 months of the trial, in the combined 18 study clusters.
Key inclusion criteria1. Women, living in the study area, who are permanent residents in the union in which their delivery or their death was identified.
2. Women and their newborn infants are included after birth, or, if a woman dies during pregnancy, after her death.
Key exclusion criteria1. Women who are temporary residents in the union in which their delivery or death was identified
2. Women who decline to be interviewed
3. Women who reside outside the study area
Date of first enrolment01/01/2009
Date of final enrolment30/06/2011

Locations

Countries of recruitment

  • Bangladesh
  • England
  • United Kingdom

Study participating centre

UCL Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

University College London (UK)
University/education

Institute of Child Health
Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
England
United Kingdom

+44 (0)20 7905 2261
g.eroglu@ich.ucl.ac.uk
http://www.ucl.ac.uk/cihd/
ROR logo https://ror.org/02jx3x895

Funders

Funder type

Charity

Big Lottery Fund Strategic Grant (UK) IS/2/010281409

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 26/09/2011 Yes No
Other publications coverage estimates 29/06/2012 Yes No
Results article results 01/09/2013 Yes No
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