Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof George Pariyo


Contact details

Makerere University
School of Public Health
College of Health Sciences
P.O Box 7072
+256 (0)41 453 0291

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Improving newborn health and survival through a community based intervention linked to health facilities: a randomised controlled cluster trial



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:

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


Secondary study design

Cluster randomised trial

Trial setting


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


Maternal and newborn health


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



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


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Women of childbearing age
2. Pregnant women
3. Newly delivered women
4. Neonates and infants

Participant type


Age group




Target number of participants

65 villages, 70000 people

Participant exclusion criteria

Refusal to consent

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Makerere University

Sponsor information


Save the Children (USA)

Sponsor details

2000 L Street NW
Suite 500
DC 20036 202.640.6661
United States of America
+1 203 221 4030

Sponsor type




Funder type


Funder name

Save the Children (USA) (ref: UG01_232)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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:
2015 results in:

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.