Plain English Summary

Not provided at time of registration

Trial website

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 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)

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 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 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

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

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

  1. 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.

  2. 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.

  3. 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.

Editorial Notes