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Improving essential maternal and newborn care in poor rural communities in Malawi
ISRCTN ISRCTN06477126
DOI 10.1186/ISRCTN06477126
ClinicalTrials.gov identifier
EudraCT number
Public title Improving essential maternal and newborn care in poor rural communities in Malawi
Scientific title Improving essential maternal and newborn care in poor rural communities in Malawi: two randomised controlled trials of community-based health promotion interventions to reduce maternal and neonatal mortality and morbidity
Acronym MaiMwana
Serial number at source Sub-grant no. 231
Study hypothesis 1. Community mobilisation through women's groups will reduce neonatal and maternal mortality rates through changes in care practices and health seeking behaviour
2. Infant care and feeding counselling for pregnant and breastfeeding mothers will change knowledge and practice relating to exclusive breastfeeding and family planning which will in turn reduce mortality rates and mother to child transmission of HIV

Please note that as of 04/06/10 this record has been updated. All updates may be found in the relevant field with the above update date. Please also note that anticipated end date has been extended from 28/02/2008 to 31/01/2009 following a Data Safety and Monitoring Board meeting on 21st October 2008. At this meeting it was also recommended that the follow up period be extended from 2 years to 3 years.
Lay summary Not provided at time of registration
Ethics approval National Health Sciences of Malawi. Date of approval: 29/01/2003 (ref: MED/4/36/I/167)
Study design 2 x 2 cluster randomised controlled trial
Countries of recruitment Malawi
Disease/condition/study domain Maternal, neonatal and child health
Participants - inclusion criteria All women aged 10-49 who agree to take part.
Participants - exclusion criteria Women who have no possibility of conceiving during the study period (women who have had hysterectomy or permanent sterilisation).
Anticipated start date 01/07/2005
Anticipated end date 31/01/2009
Status of trial Completed
Patient information material
Target number of participants As of 04/06/10: 17,280 (at time of registration 11,520)
Interventions Please note that as of 04/06/10, the data collection for this trial ended on 31/01/2009

Women's groups intervention trial: Community-based participatory women's groups to mobilise communities around mother and newborn health

Infant feeding care intervention trial: Community-based volunteer infant-feeding and care counsellors to support mothers in exclusive breastfeeding and family-planning

The two trials are part of a factorial design, where the same participants are enrolled in the control or intervention arms of each trial, producing four different groupings of intervention combinations: 12 clusters with both interventions, 12 clusters with women's groups intervention only, 12 clusters with infant feeding care intervention only and 12 clusters with no interventions.

Total duration of interventions: 3 years (A period of 9 months of data collection preceded the interventions)
Primary outcome measure(s) Current information as of 04/06/10:
For the women's groups trial:
Maternal, infant, neonatal and perinatal mortality, assessed by monthly visits for 3 years. Pregnant women are followed up until at least 6 months after birth. Any mothers or infants who have died were followed up with a verbal autopsy interview to establish the cause of death.

For the infant feeding care trial:
1. Exclusive breastfeeding rates, determined through 1-month and 6-month post-partum interviews using a structured questionnaire
2. Infant mortality assessed by monthly visits for 3 years

(Please note that at the time of registration, the total duration of follow up was 2 years)
Secondary outcome measure(s) The following were determined through 1-month and 6-month post-partum interviews using a structured questionnaire:

For the women's groups trial:
1. Changes in care taker practices and care-seeking behaviour, recognition of danger signs
2. Maternal and neonatal morbidity

For the infant feeding care trial:
1. Changes in care taker practices and care-seeking behaviour
2. Neonatal and infant morbidity
Sources of funding Current information as of 04/06/10:
Wellcome Trust (UK) - (ref: WT085417)

Initial information at time of registration:
Save the Children, Saving Newborn Lives Programme (Sub-grant no. 231)
Trial website
Publications 1. 2006 Data obtained from the women's group intervention in http://www.ncbi.nlm.nih.gov/pubmed/17011945
2. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20849613
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23683639
Contact name Miss  Guler  Eroglu
  Address Centre for International Health and Development
University College London (UCL) Institute of Child Health
30 Guilford Street
  City/town London
  Zip/Postcode WC1N 1EH
  Country United Kingdom
  Tel +44 (0)20 7905 2261
  Fax +44 (0)20 7404 2062
  Email g.eroglu@ich.ucl.ac.uk
Sponsor University College London (UK)
  Address c/o Prof Anthony Costello
Centre for International Health and Development
UCL Institute of Child Health
30 Guilford Street
  City/town London
  Zip/Postcode WC1N 1EH
  Country United Kingdom
  Tel +44 (0)20 7905 2261
  Fax +44 (0)20 7404 2062
  Email a.costello@ich.ucl.ac.uk
  Sponsor website: http://www.ich.ucl.ac.uk/ich
Date applied 13/08/2008
Last edited 22/05/2013
Date ISRCTN assigned 29/08/2008
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