Contact information
Type
Scientific
Primary contact
Prof George Pariyo
ORCID ID
Contact details
Makerere University
School of Public Health
College of Health Sciences
PO Box 7072
Kampala
-
Uganda
+256 (0)41 453 0291
gpariyo@musph.ac.ug
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Improving newborn health and survival through a community based intervention linked to health facilities: a randomised controlled cluster trial
Acronym
UNEST
Study hypothesis
Implementation of an integrated care package of four home visits by a community health worker (CHW) during pregnancy and the neonatal period to deliver one on one health messages and promoting linkage to the health facility improves the following maternal-newborn care practices by at least 20% in two years amongst the target population in rural Uganda.
Further information can be found at:
http://www.ncbi.nlm.nih.gov/pubmed/18570672
http://www.ncbi.nlm.nih.gov/pubmed/19710561
Ethics approval
Uganda National Council of Science and Technology HS626 approved from the 20/08/2009 to 20/08/2010
Study design
Randomised controlled cluster trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Home
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Maternal and newborn health
Intervention
Through formative research around evidence-based practices, and dialogue with policy and technical advisors, we will construct a home-based neonatal care package implemented by the responsible Village Health Team member, effectively a Community Health Worker. This CHW will be trained to identify pregnant women and make four home visits: two before and two just after birth. Linkages will be made to facility care and targeted messages for home-care and care-seeking delivered. The project will improve care in health units to provide standardised care for the mother and the newborn in both intervention and comparison areas.
The control area is being given the current standard of care provided by the Government. However, health facility quality improvement initiatives are being provided in both control and intervention areas in order to standardise care but also for ethical reasons. This will enable sick newborns in the control area to access care.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. In ANC:
1.1. % of pregnant women attending ANC two, four or more times
1.2. % of pregnant women who know at least two danger signs of pregnancy
1.3. % of pregnant women who prepare for birth
2. In the intrapartum period:
2.1. % of pregnant women who have a skilled attendant at delivery
2.2. % of women who went to the HC in an emergency
3. In the post-natal period:
3.1. % of babies who are initiated on breastfeeding in the first 6 hours of birth
3.2. % of babies who are exclusively breastfed during the neonatal period
3.3. % of babies whose first bath was delayed for 6 and 24 hours
3.4. % of mothers who put nothing on the cord
3.5. % of mothers who know at least 3 neonatal danger signs
3.6. % women whose children were managed in skin to skin contact after delivery.
3.7. Effectiveness of sepsis management (special studies to determine: maternal and CHW knowledge, compliance and timing of referral, and adequacy of treatment following referral)
Secondary outcome measures
1. Neonatal mortality
2. Perinatal mortality
Overall trial start date
01/07/2009
Overall trial end date
30/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women of childbearing age
2. Pregnant women
3. Newly delivered women
4. Neonates and infants
Participant type
Mixed
Age group
Adult
Gender
Female
Target number of participants
65 villages, 70000 people
Participant exclusion criteria
Refusal to consent
Recruitment start date
01/07/2009
Recruitment end date
30/12/2011
Locations
Countries of recruitment
Uganda
Trial participating centre
Makerere University
Kampala
-
Uganda
Sponsor information
Organisation
Save the Children (USA)
Sponsor details
2000 L Street NW
Suite 500
DC 20036 202.640.6661
Washington
2000
United States of America
+1 (0)203 221 4030
twebster@savechildren.org
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Save the Children (USA) (ref: UG01_232)
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
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23153395
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25843498
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/28156830
Publication citations
-
Protocol
Waiswa P, Peterson SS, Namazzi G, Ekirapa EK, Naikoba S, Byaruhanga R, Kiguli J, Kallander K, Tagoola A, Nakakeeto M, Pariyo G, The Uganda Newborn Study (UNEST): an effectiveness study on improving newborn health and survival in rural Uganda through a community-based intervention linked to health facilities - study protocol for a cluster randomized controlled trial., Trials, 2012, 13, 213, doi: 10.1186/1745-6215-13-213.
-
Results
Waiswa P, Pariyo G, Kallander K, Akuze J, Namazzi G, Ekirapa-Kiracho E, Kerber K, Sengendo H, Aliganyira P, Lawn JE, Peterson S; Uganda Newborn Study Team, Effect of the Uganda Newborn Study on care-seeking and care practices: a cluster-randomised controlled trial, Glob Health Action, 8, 24584, doi: 10.3402/gha.v8.24584.