Condition category
Pregnancy and Childbirth
Date applied
13/08/2008
Date assigned
29/08/2008
Last edited
22/05/2013
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

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

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

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes