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The effect of participatory women’s groups on birth outcomes in Bangladesh: does coverage matter?
ISRCTN ISRCTN01805825
DOI 10.1186/ISRCTN01805825
ClinicalTrials.gov identifier
EudraCT number
Public title The effect of participatory women’s groups on birth outcomes in Bangladesh: does coverage matter?
Scientific title The effect of participatory women’s groups on birth outcomes in Bangladesh: does coverage matter? A cluster randomised controlled trial
Acronym Perinatal Care Project (PCP) Diabetic Association of Bangladesh (BADAS)
Serial number at source 1VTP/07CH05
Study hypothesis We 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.
Lay summary Not provided at time of registration
Ethics approval 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)
Study design Cluster randomised controlled trial
Countries of recruitment Bangladesh
Disease/condition/study domain Maternal and Child Health
Participants - inclusion criteria 1. 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.
Participants - exclusion criteria 1. 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
Anticipated start date 01/01/2009
Anticipated end date 30/06/2011
Status of trial Completed
Patient information material
Target number of participants 16,000 births to women using the above in/exclusion criteria, during the last 24 months of the trial, in the combined 18 study clusters.
Interventions The 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.
Primary outcome measure(s) Neonatal 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 measure(s) 1. 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
Sources of funding Big Lottery Fund Strategic Grant (UK) IS/2/010281409
Trial website
Publications 1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21943044
2. 2012 coverage estimates in http://www.ncbi.nlm.nih.gov/pubmed/22747973
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23689475
Contact name Prof  Anthony  Costello
  Address UCL Institute of Child Health
Centre for International Health and Development
  City/town London
  Zip/Postcode WC1N 1EH
  Country United Kingdom
  Tel +44 (0)20 7905 2883
  Fax +44 (0)20 7404 2062
  Email a.costello@ich.ucl.ac.uk
Sponsor University College London (UK)
  Address Institute of Child Health
Centre for International Health and Development
30 Guilford Street
  City/town London
  Zip/Postcode WC1N 1EH
  Country United Kingdom
  Tel +44 (0)20 7905 2261
  Fax +44 (0)20 7404 2062
  Email g.eroglu@ich.ucl.ac.uk
  Sponsor website: http://www.ucl.ac.uk/cihd/
Date applied 28/04/2011
Last edited 22/05/2013
Date ISRCTN assigned 15/06/2011
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