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N/A N=14,490

Smart Discharges for Mom & Baby

Maternal Sepsis · Neonatal Sepsis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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