Actively Recruiting
Logistic Regression Prediction Model vs. Standard of Care for Prediction of Postpartum Hemorrhage A Pragmatic Randomized Controlled Trial
Led by Holly Ende · Updated on 2025-10-01
10000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
Holly Ende
Lead Sponsor
V
Vanderbilt University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying postpartum hemorrhage (PPH), a serious complication during and after childbirth that can cause significant health problems for mothers. This trial aims to improve how the risk of PPH is predicted using a new computer model that considers 21 factors and updates automatically during labor. The study compares this new model combined with a provider-facing alert system to current basic risk tools, with the hope of improving outcomes for mothers. The study includes two groups: one receives the usual care with a traditional category-based risk assessment, and the other group receives standard care plus the new risk prediction model. If the new model predicts a risk of 3% or higher, it triggers an alert recommending best practice steps like preventive medications. Providers can decide whether to follow these recommendations. Both groups receive standard care risk assessments as part of their admission process. Participants are all women admitted for vaginal or cesarean delivery at the medical center. Researchers will collect and compare data on a range of health outcomes related to bleeding and complications from the time of delivery until 30 days later. They will use hospital records to measure blood loss, treatments given, length of stay, and other health events. The study aims to see if the new model and alerts lead to better health outcomes for mothers during and after childbirth.
CONDITIONS
Brief Title
A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All vaginal and cesarean deliveries occurring at Vanderbilt University Medical Center
You will not qualify if you...
- Patients discharged before delivery are excluded from analysis
- Patients with a planned hysterectomy before delivery for placenta increta or percreta are excluded from the treatment algorithm and primary analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From randomization to postpartum hospital discharge (usually 2-4 days)
Participants undergo standard care risk assessment for postpartum hemorrhage. Those in the intervention group also have an additional risk prediction displayed using a novel logistic regression model with clinical decision support for elevated risk.
1 hospital stay including delivery and postpartum care
Duration - Up to 30 days postpartum
Participants are monitored for postpartum morbidity and mortality outcomes up to 30 days postpartum after hospital discharge.
Follow-up assessments up to 30 days postpartum
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
H
Holly Ende, MD
T
Tracie Baker, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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