The effect of womens' groups facilitated by Accredited Social Health Activists (ASHAs) on birth outcomes in Eastern India

ISRCTN	ISRCTN31567106
DOI	https://doi.org/10.1186/ISRCTN31567106
Secondary identifying numbers	1VTP/07CH05

Submission date: 28/04/2011
Registration date: 15/06/2011
Last edited: 05/12/2017

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

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

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

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
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
Study acronym	Jharkhand Orissa Health Action Research (JOHAR)
Study objectives	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(s)	UCL Research Ethics Committee approved in March 2008, annually reviewed, ID number: 1488/001
Health condition(s) or problem(s) studied	Maternal and Child Health
Intervention	. Participation in learning action cycle with womens groups 2. In each intervention cluster, trained and incentivised Accredited Social Health Activists and convene womens 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
Primary outcome measure	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 study start date	01/09/2010
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	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.
Key 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.
Key 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)
Date of first enrolment	01/09/2010
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

England
India
United Kingdom

Study participating centre

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

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

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	25/07/2011		Yes	No
Results article	results	01/02/2016		Yes	No

Editorial Notes

05/12/2017: internal review.
01/02/2016: Publication reference added.