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Actively Recruiting

Phase Not Applicable
FEMALE
ID06513351

Comparing Standard Care With a New Computer Model to Predict and Reduce Postpartum Hemorrhage Risk

Led by Holly Ende · Updated on 2026-07-22

12500

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 evaluating a new tool to predict the risk of postpartum hemorrhage PPH, a serious complication during and after childbirth. The study compares the current basic risk assessment method with an advanced model that uses 21 factors to calculate a more precise risk. This model updates automatically during labor and provides clinicians with a Best Practice Advisory BPA suggesting recommended actions when risk is elevated. Participants will receive standard care, including the usual category-based risk assessment. Those in the intervention group will also have the new risk prediction displayed, which triggers the BPA if the risk is 3% or higher. This advisory includes recommendations such as preventative use of tranexamic acid and second-line uterotonics, guiding providers without requiring mandatory actions. The study aims to see if this enhanced approach improves outcomes for mothers during childbirth. Throughout the study, researchers will collect data on postpartum morbidity and mortality from delivery until hospital discharge and up to 30 days after birth. They will monitor estimated blood loss, treatments for hemorrhage, blood transfusions, complications, and fetal APGAR scores at 1, 5, and 10 minutes. The total participation duration typically covers delivery through 30 days postpartum, focusing on the safety and health of both mother and baby.

CONDITIONS

Brief Title

A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • All vaginal and cesarean deliveries occurring at Vanderbilt University Medical Center
Not Eligible

You will not qualify if you...

  • Patients discharged before delivery are excluded from analysis
  • Patients with planned hysterectomy before delivery for placenta increta or percreta are excluded from the treatment algorithm and primary analysis

Research Team

H

Holly Ende, MD

T

Tracie Baker, CCRP

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