Condition category
Pregnancy and Childbirth
Date applied
24/03/2011
Date assigned
20/04/2011
Last edited
16/09/2013
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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05PC02

Study information

Scientific title

The effect of community mobilisation through women’s 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

Acronym

MaiKhanda

Study hypothesis

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

National Health Sciences Research Council (NHSRC) of Malawi 01/04/2007 (ref: Protocol # 420)

Study design

2 x 2 factorial cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 women’s group trial):
7.1. No. of women’s groups mobilized annually
7.2. Percentage of women attending women’s groups

Overall trial start date

01/06/2010

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All pregnant women who agree to take part in the programme

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

45,000

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

01/06/2010

Recruitment end date

31/12/2010

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

Sponsor type

University/education

Website

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

Funders

Funder type

Charity

Funder name

The Health Foundation (UK) 05PC02

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24030269

Publication citations

  1. Results

    Colbourn T, Nambiar B, Bondo A, Makwenda C, Tsetekani E, Makonda-Ridley A, Msukwa M, Barker P, Kotagal U, Williams C, Davies R, Webb D, Flatman D, Lewycka S, Rosato M, Kachale F, Mwansambo C, Costello A, Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial., Int Health, 2013, 5, 3, 180-195, doi: 10.1093/inthealth/iht011.

Additional files

Editorial Notes