Contact information
Type
Scientific
Primary contact
Prof Anthony Costello
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1VTP/07CH05
Study information
Scientific title
The effect of participatory womens groups on birth outcomes in Bangladesh: does coverage matter? A cluster randomised controlled trial
Acronym
Perinatal Care Project (PCP) Diabetic Association of Bangladesh (BADAS)
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Condition
Maternal and Child Health
Intervention
The intervention is a participatory learning action cycle with womens groups. In each intervention cluster, facilitators convene womens 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 womens 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 womens 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 womens health (Cycle 2), while periodically continuing to review maternal and newborn health issues. The combined 810 womens 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/01/2009
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
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.
Participant 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
Recruitment start date
01/01/2009
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Bangladesh
Trial participating centre
UCL Institute of Child Health
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Institute of Child Health
Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2261
g.eroglu@ich.ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Big Lottery Fund Strategic Grant (UK) IS/2/010281409
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
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
Publication citations
-
Protocol
Houweling TA, Azad K, Younes L, Kuddus A, Shaha S, Haq B, Nahar T, Beard J, Fottrell EF, Prost A, Costello A, , The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial., Trials, 2011, 12, 208, doi: 10.1186/1745-6215-12-208.
-
Coverage estimates
Younes L, Houweling TA, Azad K, Costello A, Fottrell E, Estimating coverage of a women's group intervention among a population of pregnant women in rural Bangladesh., BMC Pregnancy Childbirth, 2012, 12, 60, doi: 10.1186/1471-2393-12-60.
-
Results
Fottrell E, Azad K, Kuddus A, Younes L, Shaha S, Nahar T, Aumon BH, Hossen M, Beard J, Hossain T, Pulkki-Brannstrom AM, Skordis-Worrall J, Prost A, Costello A, Houweling TA, The effect of increased coverage of participatory women's groups on neonatal mortality in Bangladesh: A cluster randomized trial., JAMA Pediatr, 2013, 167, 9, 816-825, doi: 10.1001/jamapediatrics.2013.2534.