N/A
N=14,490
Smart Discharges for Mom & Baby
Maternal Sepsis · Neonatal Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT05730387 ↗Enrolled (actual)
14,490
Serious AEs
—
Results posted
Apr 2025
Primary outcome: Primary: Post-discharge Readmission or Mortality — 231; 349 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Observational only (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Female
- Sponsor
- University of British Columbia
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-discharge Readmission or Mortality |
231; 349 | — |
| SECONDARY Post-natal Care Visits |
446; 187 | — |
| SECONDARY Post-discharge Health Seeking |
230; 287; 2637; 1161 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Women and adolescent girls aged 12 and above delivering a single or multiple babies at the study hospital during the active recruitment phase.
Exclusion Criteria
- Inability, for whatever reason, to provide informed consent.
- Language barrier
- Mother is from a refugee camp
- Mother has no access to phone or other means for follow-up
- Mother lives outside of hospital catchment area
Data sourced from ClinicalTrials.gov (NCT05730387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.