Smart Discharges for Mom & Baby

NCT05730387 | Completed Results

• 1 other identifier: H21-03709
• Study Type: observational
• Target: 7,182
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Sepsis; Neonatal Sepsis

Keywords

maternal health; neonatal health; patient discharge; post-natal care

Outcome Measures

Primary Outcomes (1)

• Post-discharge Readmission or Mortality

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

  6 weeks following delivery

Secondary Outcomes (2)

• Post-natal Care Visits

  6 weeks following delivery

• Post-discharge Health Seeking

  6 weeks following delivery

Study Arms (1)

mother and newborn dyads

We will recruit 6700 mother and newborn dyads from the two participating hospitals. We will continue to follow-up with all patients enrolled in the study until 6 weeks (42 days) post delivery.

Other: Observational only

Interventions

Observational only OTHER

This is a non-interventional study

mother and newborn dyads

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population represents women living within the catchments of two study hospitals (Mbarara Regional Referral Hospital and Jinja Regional Referral Hospital) in Uganda, who present for delivery.

You may qualify if:

• Women and adolescent girls aged 12 and above delivering a single or multiple babies at the study hospital during the active recruitment phase.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 2X8, Canada

Location

Related Publications (1)

• Wiens MO, Trawin J, Pillay Y, Nguyen V, Komugisha C, Kenya-Mugisha N, Namala A, Bebell LM, Ansermino JM, Kissoon N, Payne BA, Vidler M, Christoffersen-Deb A, Lavoie PM, Ngonzi J. Prognostic algorithms for post-discharge readmission and mortality among mother-infant dyads: an observational study protocol. Front Epidemiol. 2023 Nov 29;3:1233323. doi: 10.3389/fepid.2023.1233323. eCollection 2023.

  PMID: 38455948 DERIVED

MeSH Terms

Conditions

Pregnancy Complications, Infectious; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sepsis; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Matthew O. Wiens
• Organization: Institute for Global Health at BC Children's Hospital and BC Women's Hospital + Health Centre

matthew.wiens@bcchr.ca

6048292562

Study Officials

• Matthew O Wiens, PharmD, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: February 15, 2023
• Study Start: April 14, 2022
• Primary Completion: August 31, 2023
• Study Completion: April 30, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be deposited to an open access repository with moderated access within 2 years of study completion
• Access Criteria: Moderated access on a case-by-case basis.

Locations

CA (1)