MedTrace Logo

Smart Discharges for Mom & Baby

NCT05730387 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7182

Last updated 2025-04-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Maternal Sepsis
  • Neonatal Sepsis

Interventions

OTHER

Observational only

This is a non-interventional study

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Matthew O Wiens, PharmD, PhD · University of British Columbia

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2023-08-31
Completion
2024-04-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05730387 on ClinicalTrials.gov