Skip to main content
Clinical Trials/NCT05730387
NCT05730387CompletedNot Applicable

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 Columbia1 site in 1 country7,182 target enrollmentStarted: April 14, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7,182
Locations
1
Primary Endpoint
Post-discharge Readmission or Mortality

Study Overview

Brief 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.

Detailed Description

PURPOSE

Neonatal outcomes are highly correlated with the health of the mother, an example of this is shown repeatedly by poor rates of survival of infants after maternal death. Prediction of risk, based on the mother and infant as a pair, is a major gap in current research and yet vital to the survival of both the mom and the infant. Thus, maternal and child health outcomes can be improved by identifying both mothers and babies at increased risk of mortality or serious morbidity after hospital discharge and allocating scarce resources for targeted follow-up to those most vulnerable. This allows the investigators to not only improve health outcomes but benefits the health system with efficient use of resources.

JUSTIFICATION

Since 2011, the investigators have been working with partners in Uganda to develop, validate, and implement an innovative program for children under 5 years who have been discharged following hospitalization for suspected sepsis. In this research and implementation program, called Smart Discharges, healthcare workers use an individualized risk prediction score to identify children at high risk of death or complications after discharge from a hospital following treatment for suspected sepsis. They can then use this score to guide the intensity of a counselling and community-referral program. While all participants receive counselling, only those above a certain risk threshold receive down-referrals to community health facilities. The investigators have shown that this approach may reduce post-discharge child mortality after in-hospital treatment for suspected sepsis by as much as 30%. Now, the investigators are working to expand their innovative precision public health approach to improving post-discharge care for mother-newborn dyads.

Findings will inform the development an evidence-based bundle of care for both the mother and newborn. This package will ensure that low-risk mother-infant pairs receive less burdensome (yet pragmatic and feasible) postpartum care, while high risk pairs receive a more extensive bundle of interventions (such as education, nutrition, healthcare interaction and community support). The Smart Discharges for Mom & Baby package will include support targeting aspects of both clinical and emotional wellbeing. Additional extensions of this work will include validating the risk models in women who deliver at home or suffer a stillbirth to ensure that more women and babies can benefit from the proposed intervention.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Post-discharge Readmission or Mortality

Time Frame: 6 weeks following delivery

Composite rate of maternal or neonatal death or re-admission within 6 weeks following delivery

Secondary Outcomes

  • Post-natal Care Visits(6 weeks following delivery)
  • Post-discharge Health Seeking(6 weeks following delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Matthew Wiens

Assistant Professor

University of British Columbia

Study Sites (1)

Loading locations...

Similar Trials

Smart Discharges for Mom & Baby | Clinical Trial