Improving essential maternal and newborn care in poor rural communities in Malawi

ISRCTN	ISRCTN06477126
DOI	https://doi.org/10.1186/ISRCTN06477126
Protocol serial number	Sub-grant no. 231
Sponsor	University College London (UK)
Funders	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)

Submission date: 13/08/2008
Registration date: 29/08/2008
Last edited: 22/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Guler Eroglu
Scientific

Centre for International Health and Development
University College London (UCL) Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone	+44 (0)20 7905 2261
Email	g.eroglu@ich.ucl.ac.uk

Study information

Primary study design	Interventional
Study design	2 x 2 cluster randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study acronym	MaiMwana
Study objectives	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(s)	National Health Sciences of Malawi. Date of approval: 29/01/2003 (ref: MED/4/36/I/167)
Health condition(s) or problem(s) studied	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
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)
Key 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
Completion date	31/01/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Female
Target sample size at registration	17280
Key inclusion criteria	All women aged 10-49 who agree to take part.
Key exclusion criteria	Women who have no possibility of conceiving during the study period (women who have had hysterectomy or permanent sterilisation).
Date of first enrolment	01/07/2005
Date of final enrolment	31/01/2009

Locations

Countries of recruitment

United Kingdom
England
Malawi

Study participating centre

Centre for International Health and Development

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	18/05/2013	Yes	No
Protocol article	protocol	17/09/2010	Yes	No
Other publications	Data obtained from the women's group intervention	30/09/2006	Yes	No