Condition category
Pregnancy and Childbirth
Date applied
04/06/2004
Date assigned
02/07/2004
Last edited
10/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Contact information

Type

Scientific

Primary contact

Prof Anthony Costello

ORCID ID

Contact details

30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2261
ipu@ich.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

98-CH-06

Study information

Scientific title

Acronym

MIRA (Mother and Infant Research Activities - a Nepali non-governmental organisation [NGO]) Makwanpur Study

Study hypothesis

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

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.

Study design

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

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

Phase

Not Specified

Drug names

Primary outcome measures

Neonatal mortality rate

Secondary outcome measures

1. Stillbirths and maternal deaths
2. Uptake of antenatal and delivery services
3. Home care practices
4. Infant morbidity
5. Health-care seeking

Overall trial start date

01/09/1999

Overall trial end date

01/11/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Married women aged 15 to 49 in 24 rural Village Development Committees (VDCs) in Makwanpur District, Nepal

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

24 village development committees

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/09/1999

Recruitment end date

01/11/2000

Locations

Countries of recruitment

Nepal

Trial participating centre

30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Institute of Child Health (UK)

Sponsor details

30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor type

Research organisation

Website

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

Funders

Funder type

Research organisation

Funder name

Department for International Development (DFID)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

United Nations Children's Fund (UNICEF)

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

Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15364188
2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16776818

Publication citations

  1. Manandhar DS, Osrin D, Shrestha BP, Mesko N, Morrison J, Tumbahangphe KM, Tamang S, Thapa S, Shrestha D, Thapa B, Shrestha JR, Wade A, Borghi J, Standing H, Manandhar M, Costello AM, , Effect of a participatory intervention with women's groups on birth outcomes in Nepal: cluster-randomised controlled trial., Lancet, 364, 9438, 970-979, doi: 10.1016/S0140-6736(04)17021-9.

  2. Wade A, Osrin D, Shrestha BP, Sen A, Morrison J, Tumbahangphe KM, Manandhar DS, Costello AM, Behaviour change in perinatal care practices among rural women exposed to a women's group intervention in Nepal [ISRCTN31137309]., BMC Pregnancy Childbirth, 2006, 6, 20, doi: 10.1186/1471-2393-6-20.

Additional files

Editorial Notes