A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Holly Ende
Study ID
NCT06513351
Status
Recruiting
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Conditions

  • Post Partum Hemorrhage

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Novel PPH Risk Prediction Model - Comparator Arm B — BEHAVIORAL
    Patients in this group will receive the standard care risk assessment with the addition of a recently developed, novel PPH risk prediction model, which will automatically calculate a patient's numerical risk of hemorrhage based on 21 risk factors. Elevated risk of hemorrhage (\>=3% predicted risk), as predicted by the model, will be linked to clinical decision support, including a best practice advisory with recommendations presented to providers for consideration when they access the patient's electronic health record.

Study Details

This research project aims to enhance the safety of childbirth by using advanced computer models to predict the risk of postpartum hemorrhage (PPH). PPH is a significant concern for mothers during and after delivery. Current risk assessment tools are basic and do not adapt to changing conditions. This study will investigate whether a new and recently validated model for predicting PPH, combined with a provider-facing Best Practice Advisory (BPA) regarding currently recommended strategies triggered by an increased predicted risk, can improve perinatal outcomes. This study will compare the current category based risk assessment tool with a new, enhanced prediction model which calculates risk based on 21 factors, automatically updates as new information becomes available during labor and, if elevated, provides a provider-facing Best Practice Advisory (BPA) recommending consideration of strategies that are institutionally agreed to represent high-quality practice. Investigators hypothesize that the enhanced care approach will result in improved perinatal outcomes. The goal of the study is to improve the wellbeing of mothers during childbirth by harnessing the power of modern technology and data analysis.

Key Dates

Start date
Jan 1, 2025
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
10,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Standard Care - Comparator Arm A
    Standard Care, which includes a category-based risk assessment tool as part of nursing admission workflow. The prophylactic interventions in the intervention are recommended by the tool but not specifically tied to provider-facing clinical decision support.
  • Active Comparator: Novel PPH Risk Prediction Model - Comparator Arm B
    Standard Care with addition of a recently developed, novel PPH risk prediction model.

Primary Outcome Measure

Numerical hierarchical composite score of postpartum morbidity and mortality at hospital discharge [ Time Frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37212
Holly Ende, MD
[email protected]
615-322-8476
Holly Ende, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Vanderbilt University Medical Center· Nashville, TN

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