A study on the effect of demand and supply side interventions on maternal and neonatal mortality in three districts in Malawi

ISRCTN	ISRCTN18073903
DOI	https://doi.org/10.1186/ISRCTN18073903
Secondary identifying numbers	05PC02

Submission date: 24/03/2011
Registration date: 20/04/2011
Last edited: 16/09/2013

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

Study information

Study design	2 x 2 factorial cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of community mobilisation through womens groups and health facility quality improvement on maternal and neonatal mortality in three districts of Malawi: a two-by-two factorial cluster randomised controlled trial
Study acronym	MaiKhanda
Study objectives	1. Community mobilisation through women's groups will reduce maternal and neonatal mortality rates through changes in care practices and health seeking behaviour 2. Quality improvement of obstetric and newborn care at Health Centres and Hospitals will reduce maternal and neonatal mortality rates through improvements in timely and effective management of antenatal care, labour, delivery and the post-partum period
Ethics approval(s)	National Health Sciences Research Council (NHSRC) of Malawi 01/04/2007 (ref: Protocol # 420)
Health condition(s) or problem(s) studied	Maternal and neonatal mortality
Intervention	1. Quality Improvement trial: Coaching of Health Facility staff in quality improvement methodology (including Plan-Do-Study-Act, Death Reviews, change ideas, bundles and packages) to improve obstetric and newborn care at Health Centres and Hospitals 2. Women's groups intervention trial: Community-based participatory women's groups to mobilise communities around mother and newborn health 3. 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: 15 clusters with both interventions (WG+QI), 17 clusters with the quality improvement (QI) intervention only; 16 clusters with women's group (WG) intervention only, and 28 clusters with no interventions (control) 4. Note that the original design had 15 WG+QI, 17 QI only, 24 WG only, and 26 control clusters respectively i.e. a 2 x 2 factorial of QI: 32, no QI: 32; WG: 39, no WG 39 with 4 clusters only in the QI trial and 18 clusters only in the WG trial. This was not followed because some health centres (which the clusters were formed around) were not functioning. Total duration of interventions: 27 months from 01/10/2008 to 31/12/2010 (A period of 15 months of baseline data collection (01/06/2007 to 30/09/2008) preceded the interventions)
Intervention type	Other
Primary outcome measure	1. Maternal, neonatal and perinatal mortality, assessed by monthly community surveillance of all pregnant women and their infants until two months after delivery throughout the 27 month intervention period (01/10/08 to 31/12/2010). 2. Any mothers or infants who have died were followed up with a verbal autopsy interview to establish the cause of death
Secondary outcome measures	The following were determined through monthly community surveillance, monthly health facility surveillance and collection of process data on the interventions: 1. Percentage of deliveries at a health facility (for both interventions) 2. At facility level (for the quality improvement trial): 2.1. Percentage met need for emergency obstetric care 2.2. Number of deliveries at facility 3. Percentage of maternal deaths subjected to maternal death audit 4. Case fatality rate 5. Caesarean section rate 6. Practice of signal obstetric care functions 7. At the community level (for the womens group trial): 7.1. No. of womens groups mobilized annually 7.2. Percentage of women attending womens groups
Overall study start date	01/06/2010
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	45,000
Key inclusion criteria	All pregnant women who agree to take part in the programme
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	01/06/2010
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
Malawi
United Kingdom

Study participating centre

Centre for International Health and Development

London
WC1N 1EH
United Kingdom

Sponsor information

University College London (UK)
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

Website	http://www.ucl.ac.uk/cihd
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

The Health Foundation (UK) 05PC02

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?
Results article	results	01/09/2013		Yes	No