A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage

July 20, 2026 updated by: Holly Ende

Logistic Regression Prediction Model vs. Standard of Care for Prediction of Postpartum Hemorrhage - A Pragmatic Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postpartum hemorrhage (PPH) is a common complication following vaginal or cesarean delivery and contributes significantly to maternal morbidity and mortality in the United States. There are numerous clinical factors which contribute to a patient's risk of developing PPH. Utilization of an evidence-based tool for PPH risk prediction is recommended by national societies and required by the Joint Commission.

Most currently used tools are category based and assign a low, medium, or high risk of hemorrhage. These tools fail to take advantage of the vast amounts of data and computing power available via modern electronic medical records. Predictive modeling and informatics-based solutions could help to modernize PPH risk prediction and improve patient outcomes.

This study proposes to continue standard of care risk assessment for all patients, including those randomized to the intervention arm (ARM B). Those patients in the intervention arm (ARM B) will have an additional risk prediction displayed, which will show the quantitative output from the logistic regression PPH risk prediction model, (validated in a previous study). In addition to this display, patients above a preset threshold of 3% risk will have a Best Practice Advisory (BPA) deployed to clinicians with recommended actions. These recommended actions, including the prophylactic use of tranexamic acid and second-line uterotonics, are supported by best evidence in those patients deemed to be at elevated a priori risk of PPH. These prophylactic treatments are accepted standard of care for those patients deemed high risk, and may be administered, at the discretion of the covering clinician, to patients rated high risk by the current risk assessment tool in the comparator arm (Arm A) of the study. The recommendations within the best practice advisory serve as a reminder of best practices as defined by the department and providers are not forced to follow the recommendations of the best practice advisory.

Study Type

Interventional

Enrollment (Estimated)

12500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Holly Ende, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All vaginal and cesarean deliveries occurring at Vanderbilt University Medical Center

Exclusion Criteria:

  • All patients will be randomized at the time of admission to the obstetric service. Patients who are discharged prior to delivery will be excluded from subsequent analysis. Any patients with a pre-delivery planned hysterectomy (for placenta increta or percreta) will be excluded from the treatment algorithm and primary analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Novel PPH Risk Prediction Model - Comparator Arm B
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

Patients will be assigned the most severe morbidity and mortality outcome score based on a range of criteria from 1 to 7 with 1 being the least severe and 7 being the most severe outcome. 1 is Estimated blood loss <1000 mL, 2 is Estimated blood loss >=1000 mL, 3 is Mechanical treatment of hemorrhage (uterine tamponade device insertion, uterine compression suture), 4 is Post-delivery red blood cell transfusion, 5 is Uterine artery embolization, 6 is Hysterectomy due to bleeding, and 7 is Death.

For example, a patient who experiences an estimated blood loss >=1000mL and does not experience another more serious outcome would receive a score of 2, whereas a patient who requires a hysterectomy due to bleeding might meet several of the criteria, but would receive a score of 6, as this is the most severe criteria they experience.
Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Numerical hierarchical composite score of postpartum morbidity and mortality at 30 days postpartum
Time Frame: 30 days postpartum

Patients will be assigned the most severe morbidity and mortality outcome score based on a range of criteria from 1 to 7 with 1 being the least severe and 7 being the most severe outcome. 1 is Estimated blood loss <1000 mL, 2 is Estimated blood loss >=1000 mL, 3 is Mechanical treatment of hemorrhage (uterine tamponade device insertion, uterine compression suture), 4 is Post-delivery red blood cell transfusion, 5 is Uterine artery embolization, 6 is Hysterectomy due to bleeding, and 7 is Death.

For example, a patient who experiences an estimated blood loss >=1000mL and does not experience another more serious outcome would receive a score of 2, whereas a patient who requires a hysterectomy due to bleeding might meet several of the criteria, but would receive a score of 6, as this is the most severe criteria they experience.
30 days postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated blood loss <1000 mL
Time Frame: Date of randomization up to 30 days postpartum
Number of patients with estimated blood loss <1000mL
Date of randomization up to 30 days postpartum
Estimated blood loss >=1000 mL
Time Frame: Date of randomization up to 30 days postpartum
Number of patients with estimated blood loss >=1000mL
Date of randomization up to 30 days postpartum
Mechanical treatment of hemorrhage
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who required mechanical treatment of hemorrhage (uterine tamponade device insertion, uterine compression suture)
Date of randomization up to 30 days postpartum
Post-delivery packed red blood cell transfusion
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who required post-delivery packed red blood cell transfusion
Date of randomization up to 30 days postpartum
Uterine artery embolization
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who required uterine artery embolization
Date of randomization up to 30 days postpartum
Hysterectomy due to bleeding
Time Frame: Date of randomization up to 30 days postpartum
Number of patients requiring a hysterectomy due to bleeding
Date of randomization up to 30 days postpartum
Death
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who died within 30 days postpartum
Date of randomization up to 30 days postpartum
Medication to prevent bleeding
Time Frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Number of patients who received medication to prevent bleeding
Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Estimated blood loss (mL)
Time Frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
median and interquartile range for all patients
Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Total packed red blood cells (units)
Time Frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
median and interquartile range for all patients
Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Postpartum hospital length of stay (hours)
Time Frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
median and interquartile range for all patients
Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Acute myocardial infarction
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced an acute myocardial infarction
Date of randomization up to 30 days postpartum
Aneurysm
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced an aneurysm
Date of randomization up to 30 days postpartum
Acute renal failure
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced acute renal failure
Date of randomization up to 30 days postpartum
Acute respiratory distress syndrome
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced acute respiratory distress syndrome
Date of randomization up to 30 days postpartum
Amniotic fluid embolism
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced amniotic fluid embolism
Date of randomization up to 30 days postpartum
Cardiac arrest/ventricular fibrillation
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced cardiac arrest/ventricular fibrillation
Date of randomization up to 30 days postpartum
Conversion of cardiac rhythm
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who required conversion of cardiac rhythm
Date of randomization up to 30 days postpartum
Disseminated intravascular coagulation
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced disseminated intravascular coagulation
Date of randomization up to 30 days postpartum
Blood transfusion
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who required a blood transfusion
Date of randomization up to 30 days postpartum
Eclampsia
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced eclampsia
Date of randomization up to 30 days postpartum
Heart failure/arrest during surgery or procedure
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced heart failure/arrest during surgery or procedure
Date of randomization up to 30 days postpartum
Puerperal cerebrovascular disorders
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced puerperal cerebrovascular disorders
Date of randomization up to 30 days postpartum
Pulmonary edema/acute heart failure
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced pulmonary edema/acute heart failure
Date of randomization up to 30 days postpartum
Severe anesthesia complications
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced severe anesthesia complications
Date of randomization up to 30 days postpartum
Sepsis
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced sepsis
Date of randomization up to 30 days postpartum
Shock
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced shock
Date of randomization up to 30 days postpartum
Sickle cell disease with crisis
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced sickle cell disease with crisis
Date of randomization up to 30 days postpartum
Air and thrombotic embolism
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who experienced air and thrombotic embolism
Date of randomization up to 30 days postpartum
Hysterectomy
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who required a hysterectomy
Date of randomization up to 30 days postpartum
Temporary tracheostomy
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who required a temporary tracheostomy
Date of randomization up to 30 days postpartum
Ventilation
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who required ventilation
Date of randomization up to 30 days postpartum
Post-delivery ICU admission
Time Frame: Date of randomization up to 30 days postpartum
Number of patients who required ICU admission following delivery
Date of randomization up to 30 days postpartum
Time from delivery to OR for patients requiring operative repair
Time Frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Time from delivery to entry into the operating room for dilation and curettage, or operative repair of vaginal/cervical laceration
Date of randomization to Postpartum hospital discharge (usually 2-4 days)
Fetal APGAR score at 1 minute
Time Frame: 1 minute post-delivery
The median and interquartile range of the APGAR score will be reported for all patients. The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria: appearance (skin color), pulse (heart rate), grimace (reflex irritability), activity (muscle tone) and respiration on a scale from 0 to 2. Apgar total score (obtained by summing up values from all five items) ranges from 0 to 10 with a score of 0 expressing the worst neonatal status and a score of 10 the best status.
1 minute post-delivery
Fetal APGAR score at 5 minutes
Time Frame: 5 minutes post-delivery
The median and interquartile range of the APGAR score will be reported for all patients. The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria: appearance (skin color), pulse (heart rate), grimace (reflex irritability), activity (muscle tone) and respiration on a scale from 0 to 2. Apgar total score (obtained by summing up values from all five items) ranges from 0 to 10 with a score of 0 expressing the worst neonatal status and a score of 10 the best status.
5 minutes post-delivery
Fetal APGAR score at 10 minutes
Time Frame: 10 minutes post-delivery
The median and interquartile range of the APGAR score will be reported for all patients. The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria: appearance (skin color), pulse (heart rate), grimace (reflex irritability), activity (muscle tone) and respiration on a scale from 0 to 2. Apgar total score (obtained by summing up values from all five items) ranges from 0 to 10 with a score of 0 expressing the worst neonatal status and a score of 10 the best status.
10 minutes post-delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holly Ende

Collaborators

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Holly Ende, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe