Condition category
Pregnancy and Childbirth
Date applied
15/09/2010
Date assigned
28/09/2010
Last edited
29/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In rural Nepal birth attendance by trained health workers is low. The aim of this study is to find out whether a combination of community mobilisation through women’s groups and health management committee strengthening will lead to increased birth attendance by trained health workers.

Who can participate?
Village development committees in Makwanpur District, Nepal

What does the study involve?
Participating areas are randomly allocated to either receive the intervention or serve as control areas (no intervention). In the intervention areas, Female Community Health Volunteers convene monthly women's groups to identify and address problems that prevent women from delivering either in an institution or at home with a trained health worker. Health management committees also participate in three-day workshops to find ways to improve maternal and newborn health services. Follow-up meetings are conducted every three months to review progress. The number of institutional deliveries and home deliveries conducted by trained health workers, uptake of antenatal and postnatal care, death and stillbirth rates, and maternal illness are assessed and compared between the intervention and control areas.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Institute of Child Health (UK)

When is the study starting and how long is it expected to run for?
October 2010 to September 2012

Who is funding the study?
The Wellcome Trust (UK)

Who is the main contact?
Prof Anthony Costello
a.costello@ich.ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anthony Costello

ORCID ID

Contact details

Institute of Child Health
University College London
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7242 9789
a.costello@ich.ucl.ac.uk

Type

Scientific

Additional contact

Dr DS Manandhar

ORCID ID

Contact details

MIRA (Mother Infant Research Activities) (Nepal)
PO Box 921
Thapathali
Kathmandu
-
Nepal

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

085417/Z/08/Z

Study information

Scientific title

Community mobilisation to increase delivery by trained health workers in Makwanpur district, Nepal: a cluster randomised controlled trial

Acronym

Study hypothesis

A combination of community mobilisation through women’s groups, and health management committee strengthening will lead to increased birth attendance by trained health workers, through increased institutional deliveries and increased attendance at home deliveries.

Ethics approval

1. Nepal Health Research Council, 12/02/2009, ref: 889
2. University College London (UCL) Research Ethics Committee, 13/09/2010, ref: 2257/001

Study design

Single-centre unmasked cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Maternal and newborn health

Intervention

The intervention has two components, community mobilisation through women's groups, and health management committee (HMC) strengthening. Both interventions will be implemented for two years in 21 intervention clusters.

Community mobilisation through women's groups:
A government health cadre, the female community health volunteer (FCHV) runs one women's group per month. There are at least nine FCHVs running nine women's groups per cluster (n = 189). FCHVs are supported by seven supervisors, who provide general field support, and conduct monthly training and feedback meetings with FCHVs to discuss the upcoming women's group agenda, and monitor their progress. Women's groups work through a participatory action cycle to identify local problems preventing women from delivering in an institution, or at home with a trained health worker, and then implement and evaluate strategies to address these problems.

Health Management Committee Strengthening:
There is one health institution per cluster and each institution has a health management committee. Four Appreciative Inquiry facilitators and trained representatives from the District Public Health Office conduct three-day workshops with HMCs of each health facility (n = 21). Other participants such as community representatives and health workers may also join workshops. The workshops take an Appreciative Planning and Action approach, where participants are encouraged to build on their strengths to take action to improve health facilities. Facilitators will follow-up on progress at HMC meetings approximately two months after they have completed their planning workshop, and at regular intervals thereafter.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Deliveries conducted by a trained health worker
2. Institutional deliveries

Primary and secondary outcomes will be measured through prospective identification of pregnancies. Enrolment began on 16 November 2009 and will end on 20 September 2012.

Secondary outcome measures

1. Neonatal deaths
2. Stillbirths
3. Maternal morbidities
4. Care behaviours

Primary and secondary outcomes will be measured through prospective identification of pregnancies. Enrolment began on 16 November 2009 and will end on 20 September 2012.

Overall trial start date

01/10/2010

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Measurement of outcomes:
1.1. For trained birth attendance within intervention and control clusters, women who deliver infants at gestation 28 complete weeks or greater
1.2. For mortality, women of reproductive age (12 - 49 years old) who die
1.3. Infants born within the study period
2. Intervention: the intervention involves community mobilisation through women's groups and health management committee (HMC) strengthening. Participation in women's groups and their activities is voluntary, and there are no pre-determined intervention inclusion criteria. Participation in HMC strengthening is also voluntary. Participants will usually be HMC members, but may also be community members whom HMCs invite to participate.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

8000 deliveries

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2010

Recruitment end date

30/09/2012

Locations

Countries of recruitment

Nepal

Trial participating centre

Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Institute of Child Health, University College London (UK)

Sponsor details

c/o Anthony Costello
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7242 9789
a.costello@ich.ucl.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 085417)

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/21595902

Publication citations

  1. Protocol

    Morrison J, Tumbahangphe KM, Budhathoki B, Neupane R, Sen A, Dahal K, Thapa R, Manandhar R, Manandhar D, Costello A, Osrin D, Community mobilisation and health management committee strengthening to increase birth attendance by trained health workers in rural Makwanpur, Nepal: study protocol for a cluster randomised controlled trial., Trials, 2011, 12, 128, doi: 10.1186/1745-6215-12-128.

Additional files

Editorial Notes

29/01/2016: Plain English summary added.