Condition category
Pregnancy and Childbirth
Date applied
28/04/2011
Date assigned
15/06/2011
Last edited
01/02/2016
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

Institute of Child Health
University College London
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

1VTP/07CH05

Study information

Scientific title

Community mobilisation with participatory womens’ groups facilitated by Accredited Social Health Activists (ASHAs) to improve maternal and newborn health in underserved areas of Jharkhand and Orissa (India): a cluster randomised controlled trial

Acronym

Jharkhand Orissa Health Action Research (JOHAR)

Study hypothesis

The community mobilisation intervention led by ASHAs will lead to a 30% reduction in neonatal mortality in the last 24 months of the study.

Ethics approval

UCL Research Ethics Committee approved in March 2008, annually reviewed, ID number: 1488/001

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Maternal and Child Health

Intervention

. Participation in learning action cycle with women’s groups
2. In each intervention cluster, trained and incentivised Accredited Social Health Activists and convene women’s groups
3. ASHAs are government appointed volunteers incentivised to mobilise communities for improved health outcomes, assist women to access institutional deliveries and delivery a range of primary healthcare services
4. The participatory learning and action cycle has 4 phases
5. In the first phase, groups identify and prioritise maternal and newborn health problems, then plan strategies to address these problems
6. In the second phase, they discuss and prioritise strategies to address these problems
7. In the third and fourth phases, groups put these strategies into practice, and evaluate their progress
8. The role of the ASHA as part of the intervention being tested is to activate and strengthen groups, support them in identifying problems related to maternal and newborn health, help to plan possible solutions and support the implementation and monitoring of strategies to address identified problems in the community
9. ASHAs support group meetings alongside their other activities
10. In all clusters, control and intervention, activities are implemented to strengthen Village Health Committees
11. We do not use patient information sheets 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. Maternal mortality ratio
4. Pregnancy related mortality
5. Health care seeking
6. Home care practices

Overall trial start date

01/09/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women who give birth in 30 geographic clusters during the study period
2. Women and their newborn infants are included after birth, or, if a woman dies during pregnancy, at her death.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

An estimated 6000 births to women using the above inclusion/exclusion criteria, during the last 24 months of the trial, in the combined 30 study clusters.

Participant exclusion criteria

1. Women who decline to be interviewed
2. Women who have migrated out of the study areas (classified as those who cannot be traced 9 months after a birth or death identification)

Recruitment start date

01/09/2010

Recruitment end date

31/12/2012

Locations

Countries of recruitment

India

Trial participating centre

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) ref: 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

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21787392
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26823213

Publication citations

  1. Protocol

    Tripathy P, Nair N, Mahapatra R, Rath S, Gope RK, Rath S, Bajpai A, Singh V, Nath V, Ali S, Kundu AK, Choudhury D, Ghosh S, Sarbani S, Sinha R, Pagel C, Costello A, Houweling TA, Prost A, Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs) to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial., Trials, 2011, 12, 182, doi: 10.1186/1745-6215-12-182.

Additional files

Editorial Notes

01/02/2016: Publication reference added.