Condition category
Pregnancy and Childbirth
Date applied
31/10/2009
Date assigned
17/02/2010
Last edited
28/01/2016
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

Prof George Pariyo

ORCID ID

Contact details

Makerere University
School of Public Health
College of Health Sciences
P.O 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 below 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

Patient

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
+1 203 221 4030
twebster@savechildren.org

Sponsor type

Charity

Website

http://www.savechildren.org

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

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

28/01/2016: Publication reference added.