Condition category
Pregnancy and Childbirth
Date applied
11/03/2009
Date assigned
25/06/2009
Last edited
11/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anthony Costello

ORCID ID

Contact details

UCL Centre for International Health and Development
30 Guilford Street
London
WC1N 1EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A cluster randomised controlled trial of the impact of community women's groups and sepsis management by community volunteers on newborn survival and maternal and infant nutrition

Acronym

MIRA Dhanusha

Study hypothesis

1. A participatory intervention with women's groups will be associated with reductions in perinatal and neonatal mortality
2. Work by women's groups on dietary issues will be associated with improvements in maternal and infant nutrition, and possibly in perinatal and neonatal mortality
3. Training of community volunteers in the recognition and management of neonatal sepsis will be associated with increases in identification and treatment of neonatal sepsis, and improvements in neonatal mortality

Ethics approval

1. Nepal Health Research Council Ethics Committee (Nepal) gave approval on the 25th November 2004
2. Ethics Committee of the Institute of Child Health and Great Ormond Street Hospital for Children (UK) gave approval on the 14th March 2005

Study design

Factorial 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

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

Condition

Neonatal mortality; neonatal sepsis

Intervention

This is a factorial cluster randomised controlled trial involving 60 village development committee clusters.

Female Community Health Volunteers will be supported in convening monthly women's groups. The groups will work through an action research cycle in which they:
1. Identify local issues around maternity, newborn health and nutrition
2. Prioritise key problems
3. Develop strategies to address them
4. Implement the strategies
5. Evaluate their success

Female Community Health Volunteers will be trained to care for vulnerable newborn infants. They will:
1. Identify local births
2. Identify low birth weight infants
3. Identify possible newborn infection
4. Manage the process of treatment and referral
5. Follow up infants and support families

Total duration of treatment: 2 years. Total duration of follow-up: 3 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Neonatal mortality rates. Outcome measures are collected prospectively on an ongoing basis, so no specific timepoints for measurement. However, for the purposes of analysis of the trial, we will look at both primary and secondary outcome measures annually for 3 years.

Secondary outcome measures

1. Community groups:
1.1. Care practices and health care seeking behaviour
2. Stillbirth rates
3. Maternal mortality ratios
2. Sepsis management:
2.1. Identification and treatment of neonatal sepsis by community health volunteers
2.2. Causes of death assessed by community verbal autopsy

Outcome measures are collected prospectively on an ongoing basis, so no specific timepoints for measurement. However, for the purposes of analysis of the trial, we will look at both primary and secondary outcome measures annually for 3 years.

Overall trial start date

01/01/2008

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Main target population:
1. Women of reproductive age, of whom there are 140,000
2. Infants under a year of age, of whom there are 19,000
3. 26,000 pregnancies expected annually in the district

Key participants:
Women who either join community groups or have a pregnancy. The women's group intervention involves social mobilisation and group membership and activities will not be restricted to women of reproductive age. Since the aim is to improve the situation of pregnant women and their newborn infants, any participant who may affect this situation may be involved. Particular stakeholders may be older women, male community members, health workers and local opinion formers. All women and their newborn infants will be eligible to participate in the data collection exercise, for which enrolment will occur either during pregnancy or in the post-natal period.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100 births per cluster per year, giving 200 births in 2 years and 12000 births in total.

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

01/01/2008

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Nepal

Trial participating centre

UCL Centre for International Health and Development
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

University College London (UCL) Centre for International Health and Development (UK)

Sponsor details

c/o Professor Anthony Costello
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2261
a.costello@ich.ucl.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

Research organisation

Funder name

UBS Optimus Foundation (Switzerland)

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. protocol in http://www.ncbi.nlm.nih.gov/pubmed/21635791

Publication citations

  1. Protocol

    Shrestha BP, Bhandari B, Manandhar DS, Osrin D, Costello A, Saville N, Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial., Trials, 2011, 12, 136, doi: 10.1186/1745-6215-12-136.

Additional files

Editorial Notes