Community mobilisation to increase delivery by trained health workers in Makwanpur district, Nepal
| ISRCTN | ISRCTN99834806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99834806 |
| Secondary identifying numbers | 085417/Z/08/Z |
- Submission date
- 15/09/2010
- Registration date
- 28/09/2010
- Last edited
- 18/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
Institute of Child Health
University College London
30 Guilford Street
London
WC1N 1EH
United Kingdom
| Phone | +44 (0)20 7242 9789 |
|---|---|
| a.costello@ich.ucl.ac.uk |
Scientific
MIRA (Mother Infant Research Activities) (Nepal)
PO Box 921
Thapathali
Kathmandu
-
Nepal
Study information
| Study design | Single-centre unmasked cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Community mobilisation to increase delivery by trained health workers in Makwanpur district, Nepal: a cluster randomised controlled trial |
| Study objectives | A combination of community mobilisation through womens 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(s) | 1. Nepal Health Research Council, 12/02/2009, ref: 889 2. University College London (UCL) Research Ethics Committee, 13/09/2010, ref: 2257/001 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2010 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 8000 deliveries |
| Total final enrolment | 13721 |
| Key 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. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/10/2010 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- England
- Nepal
- United Kingdom
Study participating centre
WC1N 1EH
United Kingdom
Sponsor information
University/education
c/o Anthony Costello
30 Guilford Street
London
WC1N 1EH
England
United Kingdom
| Phone | +44 (0)20 7242 9789 |
|---|---|
| a.costello@ich.ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/cihd/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
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 | 19/05/2011 | Yes | No | |
| Results article | results | 06/05/2020 | 18/02/2021 | Yes | No |
Editorial Notes
18/02/2021: Publication reference and total final enrolment added.
29/01/2016: Plain English summary added.
