Contact information
Type
Scientific
Primary contact
Miss Guler Eroglu
ORCID ID
Contact details
Centre for International Health and Development
University College London (UCL) Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2261
g.eroglu@ich.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Sub-grant no. 231
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Not Specified
Patient information sheet
Condition
Maternal, neonatal and child health
Intervention
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)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/07/2005
Overall trial end date
31/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
All women aged 10-49 who agree to take part.
Participant type
Patient
Age group
Other
Gender
Female
Target number of participants
As of 04/06/10: 17,280 (at time of registration 11,520)
Participant exclusion criteria
Women who have no possibility of conceiving during the study period (women who have had hysterectomy or permanent sterilisation).
Recruitment start date
01/07/2005
Recruitment end date
31/01/2009
Locations
Countries of recruitment
Malawi
Trial participating centre
Centre for International Health and Development
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
c/o Prof Anthony Costello
Centre for International Health and Development
UCL Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7905 2261
a.costello@ich.ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Current information as of 04/06/10:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Wellcome Trust (UK) - (ref: WT085417)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Funder name
Initial information at time of registration:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Save the Children, Saving Newborn Lives Programme (Sub-grant no. 231)
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. 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
Publication citations
-
Protocol
Lewycka S, Mwansambo C, Kazembe P, Phiri T, Mganga A, Rosato M, Chapota H, Malamba F, Vergnano S, Newell ML, Osrin D, Costello A, A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality., Trials, 2010, 11, 88, doi: 10.1186/1745-6215-11-88.
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Results
Lewycka S, Mwansambo C, Rosato M, Kazembe P, Phiri T, Mganga A, Chapota H, Malamba F, Kainja E, Newell ML, Greco G, Pulkki-Brännström AM, Skordis-Worrall J, Vergnano S, Osrin D, Costello A, Effect of women's groups and volunteer peer counselling on rates of mortality, morbidity, and health behaviours in mothers and children in rural Malawi (MaiMwana): a factorial, cluster-randomised controlled trial., Lancet, 2013, 381, 9879, 1721-1735, doi: 10.1016/S0140-6736(12)61959-X.
-
Rosato M, Mwansambo CW, Kazembe PN, Phiri T, Soko QS, Lewycka S, Kunyenge BE, Vergnano S, Osrin D, Newell ML, Costello AM, Women's groups' perceptions of maternal health issues in rural Malawi., Lancet, 2006, 368, 9542, 1180-1188, doi: 10.1016/S0140-6736(06)69475-0.