NCT02605369

SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan

Completed NA Last updated 10 October 2023

What this trial tests

NA trial testing Intervention arm: An integrated package in Neonatal Death in 1,877 participants. Completed in 28 February 2019.

Timeline

3 January 2018

Primary endpoint
28 February 2019

28 February 2019

Quick facts

Lead sponsor	Makerere University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,877
Start date	3 January 2018
Primary completion	28 February 2019
Estimated completion	28 February 2019
Sites	1 location across Uganda

Drugs / interventions tested

• Intervention arm: An integrated package

Conditions studied

• Neonatal Death — all drugs for Neonatal Death →
• Preterm Birth — all drugs for Preterm Birth →
• Low Birthweight — all drugs for Low Birthweight →
• Neonatal Hypoglycemia — all drugs for Neonatal Hypoglycemia →

Sponsor

Makerere University

Who can join

Eligibility, female only, with Neonatal Death or Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020. Yet, only 57% of pregnant Ugandan women choose to deliver at health facilities. This unacceptably low coverage of facility based births could explain, in part, the high maternal and perinatal mortality estimates in Uganda. While multiple studies have examined factors associated with this low utilization of health services around the time of birth, there is inadequate implementation research exploring the best systematic methods that could promote uptake and scale up of facility based births. This study will therefore examine the effect of an intervention package (peer counselling by pregnancy buddies on facility based births, mobile phone messaging promoting facility based births and provision of mama-kits) on the frequency of facility based births and perinatal mortality. The study, a cluster randomized community based intervention trial in post-conflict Northern Uganda, will provide data crucial in framing national policy regarding measures to promote the use of health facilities.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neonatal hypothermia in Northern Uganda: a community-based cross-sectional study.
   Mukunya D, Tumwine JK, Nankabirwa V, Odongkara B, et al · · 2021 · cited 19× · PMID 33574146 · DOI 10.1136/bmjopen-2020-041723
2. Prevalence and factors associated with neonatal hypoglycemia in Northern Uganda: a community-based cross-sectional study.
   Mukunya D, Odongkara B, Piloya T, Nankabirwa V, et al · · 2020 · cited 11× · PMID 33292804 · DOI 10.1186/s41182-020-00275-y
3. Incidence and Risk Factors for Low Birthweight and Preterm Birth in Post-Conflict Northern Uganda: A Community-Based Cohort Study.
   Odongkara B, Nankabirwa V, Ndeezi G, Achora V, et al · · 2022 · cited 5× · PMID 36231374 · DOI 10.3390/ijerph191912072
4. Can an integrated intervention package including peer support increase the proportion of health facility births? A cluster randomised controlled trial in Northern Uganda.
   Nankabirwa V, Mukunya D, Ndeezi G, Odongkara B, et al · · 2024 · cited 2× · PMID 38326267 · DOI 10.1136/bmjopen-2022-070798
5. Assessing a bundle of peer counseling, mobile phone messages, and mama kits in promoting timely initiation of and exclusive breastfeeding in Uganda: A cluster randomized controlled study.
   Mukunya D, Tumwine JK, Ndeezi G, Musaba MW, et al · · 2025 · PMID 39854391 · DOI 10.1371/journal.pone.0317200
6. Low birthweight increased the risk of neonatal death twenty-folds in Northern Uganda: a community-based cohort study
   Odongkara B, Nankabirwa V, Achora V, Arach AA, et al · · 2024 · DOI 10.1101/2024.04.25.24306373