Improving essential maternal and newborn care in poor rural communities in Malawi
| ISRCTN | ISRCTN06477126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06477126 |
| Secondary identifying numbers | 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
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 |
|---|---|
| g.eroglu@ich.ucl.ac.uk |
Study information
| Study design | 2 x 2 cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| 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 | 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 study start date | 01/07/2005 |
| Completion date | 31/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Female |
| Target number of participants | As of 04/06/10: 17,280 (at time of registration 11,520) |
| 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
- England
- Malawi
- United Kingdom
Study participating centre
Centre for International Health and Development
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
c/o Prof Anthony Costello
Centre for International Health and Development
UCL Institute of Child Health
30 Guilford Street
London
WC1N 1EH
England
United Kingdom
| Phone | +44 (0)20 7905 2261 |
|---|---|
| a.costello@ich.ucl.ac.uk | |
| Website | http://www.ich.ucl.ac.uk/ich |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Current information as of 04/06/10:
No information available
Wellcome Trust (UK) - (ref: WT085417)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Initial information at time of registration:
No information available
Save the Children, Saving Newborn Lives Programme (Sub-grant no. 231)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Data obtained from the women's group intervention | 30/09/2006 | Yes | No | |
| Protocol article | protocol | 17/09/2010 | Yes | No | |
| Results article | results | 18/05/2013 | Yes | No |
