Impact of a community-based participatory intervention to improve essential newborn care (ENC) in rural Nepal: a randomised controlled trial
| ISRCTN | ISRCTN31137309 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31137309 |
| Protocol serial number | 98-CH-06 |
| Sponsor | Institute of Child Health (UK) |
| Funders | Department for International Development (DFID), The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland), United Nations Children's Fund (UNICEF) |
- Submission date
- 04/06/2004
- Registration date
- 02/07/2004
- Last edited
- 10/09/2007
- 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
Scientific
30 Guilford Street
London
WC1N 1EH
United Kingdom
| Phone | +44 (0)20 7905 2261 |
|---|---|
| ipu@ich.ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | MIRA (Mother and Infant Research Activities - a Nepali non-governmental organisation [NGO]) Makwanpur Study |
| Study objectives | Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years. 90% of deliveries in the poorest quintile of households happen at home. We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates. |
| Ethics approval(s) | The study was approved by the Nepal Health Research Council and the ethics committee of the Institute of Child Health and Great Ormond Street Hospital for Children. |
| Health condition(s) or problem(s) studied | Neonatal mortality |
| Intervention | 12 local female facilitators work within VDCs in the Makwanpur District in Nepal to explore perinatal health issues, with one in each of the 12 intervention VDCs. Their role is to act as a change agent rather than a teacher, to activate and strengthen existing mothers' groups, support them in identifying and prioritising maternal and neonatal problems, help to identify possible solutions and support the planning, implementation and monitoring of the solution strategies in the community. Each women's group moves through a participatory planning cycle of assessment, sharing experiences, planning, action and reassessment with the aim of improving essential maternal and newborn care. We have also trained women identified by local community groups as baby monitors to spot high risk newborn infants soon after birth. The study will compare outcomes including neonatal and perinatal mortality rates, perinatal care practices and health service utilisation in 12 village development committee areas (8,000 people per VDC), compared with 12 matched areas where the intervention is not implemented. Married women of reproductive age (15-49 years) within the study area have been identified and are visited monthly by study personnel. All pregnancies occurring within the cohort will be followed until at least six weeks after delivery to determine the outcome of birth. |
| Intervention type | Other |
| Primary outcome measure(s) |
Neonatal mortality rate |
| Key secondary outcome measure(s) |
1. Stillbirths and maternal deaths |
| Completion date | 01/11/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 24 |
| Key inclusion criteria | Married women aged 15 to 49 in 24 rural Village Development Committees (VDCs) in Makwanpur District, Nepal |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 01/09/1999 |
| Date of final enrolment | 01/11/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
- Nepal
Study participating centre
30 Guilford Street
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/09/2004 | Yes | No | ||
| Other publications | 15/06/2006 | Yes | No | ||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
