Condition category
Pregnancy and Childbirth
Date applied
21/08/2007
Date assigned
23/08/2007
Last edited
13/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Improving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have generally been rural, but India is urbanizing. While working with health services to improve their quality of care, the trial tests an intervention in which slum-dweller women’s groups try to improve health during pregnancy and birth, and for newborn babies in their own communities.

Who can participate?
Key participants will be women who join the community groups. We will try to involve young women and mothers, but older women may also get involved. Group members will reach out to other women and key stakeholders in their neighbourhoods. Since the aim is to improve the health of pregnant women and their newborn infants, any participant who may influence this situation may be involved. Particular examples may be older women, male community members and leaders, health workers and local opinion formers. The project outcomes will be measured by checking for all births and deaths in the project areas. All women and their newborn infants will be eligible to participate in this process, which will involve an interview as close to delivery as possible.

What does the study involve?
We will employ local community-based female facilitators to convene groups and help them to explore maternal and neonatal health issues. The groups will meet fortnightly through a seven-phase process of sharing experiences, discussion of the issues raised, discovery of potential community strengths, building of a vision for action, design and implementation of community strategies, and evaluation. The process is one of learning from each other and solving problems together.
48 slum areas have been selected randomly. 24 will have women’s groups. 24 will not, but both sets of areas will benefit from health service quality improvement. We will collect information about births, healthcare and outcomes in all 48 areas and compare the two sets. We are particularly interested in seeing if the women’s groups make mothers more likely to have antenatal care and safe deliveries, and improve the survival of their babies.

What are the possible benefits and risks of participating?
We don’t know if the women’s groups will improve mother and baby health. They have not been tested enough for us to have an opinion on whether they will be successful in a city. Since the trial is part of the City Initiative for Newborn Health, all the areas involved will benefit from improvement of provision and quality of maternal and newborn services at health posts, maternity homes, peripheral hospitals and tertiary hospitals.

Where is the study run from?
SNEHA (Society for Nutrition, Education and Health Action), Mumbai, Maharashtra, India.

When is the study starting and how long is it expected to run for?
The study started in October 2006 and ended in September 2009.

Who is funding the study?
The Wellcome Trust.

Who is the main contact?
Neena Shah More. SNEHA, Urban Health Centre, 60 Feet Road, Dharavi, Mumbai 400 017, Maharashtra, India.
David Osrin. Institute for Global Health, UCL Institute of Child Health, 30 Guilford Street, London WC1N 1EH, UK

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Osrin

ORCID ID

Contact details

30 Guilford Street
London
WC1N 1EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06PC02

Study information

Scientific title

Cluster-randomised controlled trial of community mobilisation in Mumbai slums to improve care during pregnancy, delivery, postpartum and for the newborn

Acronym

CINH Community Mobilisation

Study hypothesis

Will a community mobilisation intervention improve maternal and neonatal home care, service uptake, morbidity and mortality in slum communities of Mumbai?

Ethics approval

Approval is implicit in an agreement between the implementing NGO (Society for Nutrition, Education and Health Action - SNEHA, Mumbai) and the Municipal Corporation of Greater Mumbai, which covers the activities of the City Initiative for Newborn Health, of which the trial is one component.

Specific ethics approval was gained from the Independent Ethics Committee for Research on Human Subjects (IECRHS), Mumbai on the 18 June 2007 (ref: 1433).

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Maternal and child health

Intervention

The intervention comprises a series of meetings of community women's groups in 24 slum clusters. It is delivered by community facilitators employed by the project. Its duration in this form will be from January 2007 to January 2009. However, the aim of the intervention is to stimulate sustainable community participation, and we would hope that the intervention continues indefinitely through local efforts.

In each intervention cluster, a facilitator will convene community groups to explore maternal and neonatal health issues. Groups will meet once or twice monthly and move through action research cycles.

The programme inputs can be itemised as:
1. Recruitment, training, supervision and remuneration of facilitators. 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 she requires a grasp of health issues and some knowledge of potential interventions, she needs to be a facilitator rather than a teacher. As such, she may act as a broker of information and communication but her prime importance is as a catalyst for community mobilisation
2. Development of tools for conducting group meetings, process evaluation and documentation
3. Recruitment, training, supervision and remuneration of a supervisory cadre to support the community-based facilitators

The control group (24 slum clusters) do not receive an analogous intervention. Control areas benefit from the health service provision activities of the City Initiative for Newborn Health: improved maternal and newborn care at health posts, maternity homes, general hospitals and tertiary hospitals.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Neonatal mortality rate.

Outcomes will be evaluated after 2 years of data collection, but are measured continuously through the same prospective registration system. Births in the 48 clusters under surveillance are identified by local women, who notify interviewers employed by the project. An interview is taken at 6 weeks postpartum for each birth. The registration system provides data on maternal survival, stillbirths and neonatal outcomes. It also provides data on care during pregnancy, delivery and postpartum, both at home and through health services.

Secondary outcome measures

Antenatal, delivery and postnatal care uptake.

Outcomes will be evaluated after 2 years of data collection, but are measured continuously through the same prospective registration system. Births in the 48 clusters under surveillance are identified by local women, who notify interviewers employed by the project. An interview is taken at 6 weeks postpartum for each birth. The registration system provides data on maternal survival, stillbirths and neonatal outcomes. It also provides data on care during pregnancy, delivery and postpartum, both at home and through health services.

Overall trial start date

01/01/2007

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Women who give birth in 48 vulnerable slum communities during the study period. Any woman who gives birth in the study area is potentially a participant in the data collection activities. The age range would be 12 to 49 years.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

10,000 (end recruitment date is 01/01/2009)

Participant exclusion criteria

Women who decline to be interviewed.

Recruitment start date

01/01/2007

Recruitment end date

01/01/2010

Locations

Countries of recruitment

India

Trial participating centre

30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

The Institute of Child Health (UK)

Sponsor details

University College London
30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor type

University/education

Website

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

Funders

Funder type

Industry

Funder name

ICICI Bank Ltd (India) - Social Initiatives Group

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Wellcome Trust (UK) (grant ref: 081052)

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. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18261242
2. 2012 community mobilisation results in http://www.ncbi.nlm.nih.gov/pubmed/22802737
3. 2012 stillbirth and newborn death results in http://www.ncbi.nlm.nih.gov/pubmed/22646304

Publication citations

  1. Results

    More NS, Bapat U, Das S, Patil S, Porel M, Vaidya L, Koriya B, Barnett S, Costello A, Fernandez A, Osrin D, Cluster-randomised controlled trial of community mobilisation in Mumbai slums to improve care during pregnancy, delivery, postpartum and for the newborn., Trials, 2008, 9, 7, doi: 10.1186/1745-6215-9-7.

  2. Community mobilisation results

    More NS, Bapat U, Das S, Alcock G, Patil S, Porel M, Vaidya L, Fernandez A, Joshi W, Osrin D, Community mobilization in Mumbai slums to improve perinatal care and outcomes: a cluster randomized controlled trial., PLoS Med., 2012, 9, 7, e1001257, doi: 10.1371/journal.pmed.1001257.

  3. Stillbirth and newborn death results

    Bapat U, Alcock G, More NS, Das S, Joshi W, Osrin D, Stillbirths and newborn deaths in slum settlements in Mumbai, India: a prospective verbal autopsy study., BMC Pregnancy Childbirth, 2012, 12, 39, doi: 10.1186/1471-2393-12-39.

Additional files

Editorial Notes