Actively Recruiting

Phase Not Applicable
FEMALE
NCT06513351

A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage

Led by Holly Ende · Updated on 2025-10-01

10000

Participants Needed

1

Research Sites

130 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

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.

CONDITIONS

Official 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 a planned pre-delivery hysterectomy for placenta increta or percreta are excluded from the treatment algorithm and primary analysis

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212

Actively Recruiting

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Research Team

H

Holly Ende, MD

CONTACT

T

Tracie Baker, CCRP

CONTACT

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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