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11 February 2012
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| [ Print-friendly version ] |
| Uganda Newborn Survival Study: improving newborn health and survival through a community based intervention linked to health facilities |
| ISRCTN | ISRCTN50321130 |
| ClinicalTrials.gov identifier | |
| Public title | Uganda Newborn Survival Study: improving newborn health and survival through a community based intervention linked to health facilities |
| Scientific title | Improving newborn health and survival through a community based intervention linked to health facilities: a randomised controlled cluster trial |
| Acronym | UNEST |
| Serial number at source | N/A |
| 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. |
| Lay summary | |
| Ethics approval | Uganda National Council of Science and Technology HS626 approved from the 20th August 2009 to 20th August 2010. |
| Study design | Randomised controlled cluster trial |
| Countries of recruitment | Uganda |
| Disease/condition/study domain | Maternal and newborn health |
| Participants - inclusion criteria |
1. Women of childbearing age
2. Pregnant women 3. Newly delivered women 4. Neonates and infants |
| Participants - exclusion criteria | Refusal to consent |
| Anticipated start date | 01/07/2009 |
| Anticipated end date | 30/12/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 65 villages, 70000 people |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
1. Neonatal mortality
2. Perinatal mortality |
| Sources of funding | Save the Children (USA) (ref: UG01_232) |
| Trial website | |
| Publications |
1. 2008 acceptability results: http://www.ncbi.nlm.nih.gov/pubmed/18570672
2. 2009 population study: http://www.ncbi.nlm.nih.gov/pubmed/19710561 |
| Contact name | Prof George Pariyo |
| Address |
Makerere University
School of Public Health College of Health Sciences P.O Box 7072 |
| City/town | Kampala |
| Zip/Postcode | - |
| Country | Uganda |
| Tel | +256 (0)41 453 0291 |
| Fax | +256 (0)41 454 0633 |
| gpariyo@musph.ac.ug | |
| Sponsor | Save the Children (USA) |
| Address |
2000 L Street NW
Suite 500 DC 20036 202.640.6661 |
| City/town | Washington |
| Zip/Postcode | 2000 |
| Country | United States of America |
| Tel | +1 203 221 4030 |
| Fax | +1 203 221 4030 |
| twebster@savechildren.org | |
| Sponsor website: | http://www.savechildren.org |
| Date applied | 31/10/2009 |
| Last edited | 17/02/2010 |
| Date ISRCTN assigned | 17/02/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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