CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7,182 enrolled
Drug / intervention
Observational onlyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT05730387
NCT05730387N/ACompleted

Smart Discharges for Mom & Baby: Saving Mother-newborn Dyads by Developing a Predictive Risk Model to Identify Vulnerable Dyads and Guide Delivery of Evidence-based, Locally-informed Interventions for Targeted Post-discharge Care

University of British Columbia·observational·Posted Feb 15, 2023·Updated Apr 10, 2025

In Brief

An observational study evaluating Observational only for Maternal Sepsis and Neonatal Sepsis. Completed, enrolled 7,182 participants across 1 site.

Detailed Summary

This study aims to build a predictive algorithm that identifies mother-newborn dyads most at risk of death or complications in the 6 weeks after birth. The investigators will conduct a multi-site cohort study with 7,000 dyads in Uganda and engage with local stakeholders (e.g., patients, healthcare workers, and health policy-makers) to develop an evidence-based bundle of interventions that address key practice gaps and the critical factors leading to death and complications in these dyads. In the investigator's epidemiological study of post-delivery post-discharge outcomes in 3,236 dyads in Uganda (2017-2020), results indicated that most newborn and maternal readmissions were due to infectious illness (i.e. sepsis, surgical site infections, malaria), and primarily occurred early in the post-discharge period. Thus, the focus of this study will be identifying interventions that target these common and early outcomes, for both mothers and newborns, using World Health Organization recommendations, patient and caregiver experiences, and stakeholder recommendations. If successful, results will inform the next steps of this project, which is the external validation of the model and clinical evaluation of a personalized approach to improving health outcomes and health-seeking behaviour for mothers and newborns.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedFeb 15, 2023
Enrollment StartApr 14, 2022
Primary CompletionAug 31, 2023
Study CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.4 years ago

Interventions

Observational onlyother

This is a non-interventional study