Plain English Summary
Background and study aims
The number of women who die from birth related complications in Zambia is among the highest in the world, with 591 maternal deaths occurring per 100,000 live births. Most maternal deaths occur among the poorest communities, in rural areas. Some 59% Zambians live in poverty. Only 48% of deliveries are attended by a skilled health worker at an appropriate health care facility such as a hospital (referred to as institutional deliveries), despite there being high antenatal care coverage of 93%. One of the reasons behind such a low number of institutional deliveries include demands by service providers that mothers bring in commodities for delivery. Not being able to meet these demands, pregnant women have been left with no choice but to remain and deliver at home relying on family members who have no training. Providing non-financial incentives for pregnant women in form of mother-baby delivery packs containing basic hygienic delivery supplies will attract pregnant women to deliver in health institutions. This in turn will increase institutional deliveries in rural Zambia and eventual ly contribute to a reduction of maternal mortality. Addressing hidden barriers to institutional deliveries is a key intervention for reducing maternal mortality in poor rural Zambia. The study aims are to determine factors associated with place of delivery and the effect of provision of non-financial incentives in Monze district, a rural region in Zambia on health facilities deliveries.
Who can participate?
Pregnant women resident in the study area (Monze district) until delivery time and able to accept the incentives.
What does the study involve?
The study involves two rural regions in Monze separated in the middle by an urban region. One region is randomly allocated to be the intervention region. The other is assigned as the control region. Pregnant women living in the intervention region are given a mother-baby delivery pack containing basic hygienic delivery supplies (gloves, disinfectant, baby blanket, napkins, soap, bottle of vaseline, baby wrapper and insecticide treated mosquito net) and health education. Pregnant women in the control region receive routine health services. The number of institutional deliveries in both regions is then monitored over a period of one year, along with other outcomes such as attendance at antenatal care clinics and any birth related complications.
What are the possible benefits and risks of participating?
There are no direct medical benefits to participants in this study. However, participants receive information on the benefits of delivering in a health facility assisted by a qualified health worker. Other women may benefit in the future if the information gained from the study leads to reduced maternal deaths and its related complications. This study do not pose any risks, discomfort or embarrassment to participants.
Where is the study run from?
Monze District (Zambia)
When is the study starting and how long is it expected to run for?
January 2014 to December 2014
Who is funding the study?
Financial support has been provided by Irish Aid, WHO and UNICEF
Who is the main contact?
Dr Victor M Mukonka
vmukonka@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Victor Mukonka
ORCID ID
http://orcid.org/0000-0002-8766-6483
Contact details
Copperbelt University
School of Medicine
Ndola Central Hospital
6th Floor
Ndola
71191
Zambia
+260 212 618511
vmukonka@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Community intervention trial to determine the effect of provision of non-financial incentives on increasing institutional deliveries in order to contribute to reduction of maternal mortality
Acronym
VMM-RCT
Study hypothesis
The provision of a non-financial incentive in the form of a mother-baby delivery pack with key items mothers require for institutional delivery accompanied with a health education and information leaflet will increase the numbers of women delivered by skilled birth attendants at a health facility, with subsequent reduction in maternal and neonatal mortality and morbidity.
Ethics approval
Tropical Diseases Research Centre, Zambia, 10/09/2013, ref: TDRC IRB 00002911
Study design
Prospective comparative community intervention trial with two comparable rural regions in Monze District, Zambia
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Use contact details to request a information sheet
Condition
Maternal mortality and morbidity
Intervention
Two comparable rural regions in Monze separated in the middle by urban region.
1. The intervention arm receives a non-financial incentive in the form of a mother-baby delivery pack containing basic hygienic delivery supplies (gloves, disinfectant, baby blanket, napkins,soap,bottle of vaseline, baby wrapper and insecticide treated mosquito net)
2. The control group continues with routine health services
Intervention type
Other
Phase
Drug names
Primary outcome measure
Increase in institutional deliveries by skilled birth attendants. Analysis will be comparison of number of institutional deliveries in the two arms over the period of one year and pre (2012 & 2013) and post (2014)
Secondary outcome measures
1. Antenatal care attendance
2. Birth preparedness
3. Delivery complications
4. Postnatal attendance
5. Under five clinic attendance
Overall trial start date
01/01/2013
Overall trial end date
30/11/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Resident in the study area until delivery time
2. Able to accept the incentives
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
3000
Participant exclusion criteria
1. Unable to reside in the study area until delivery
2. Unable to accept the incentives
Recruitment start date
01/01/2014
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Zambia
Trial participating centre
Monze District in Zambia
Monze
Zambia
Funders
Funder type
Government
Funder name
Irish Aid
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list