Condition category
Pregnancy and Childbirth
Date applied
21/02/2015
Date assigned
05/09/2015
Last edited
27/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Irish Aid

Sponsor details

Embassy of Ireland
6663 Katima Mulilo Road
P.O. Box 34923
Lusaka
10101
Zambia

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes