A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage

NCT06513351 | Recruiting DMC

• 1 other identifier: 240187
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Post Partum Hemorrhage

Keywords

Post Partum Hemorrhage; Cesarean Section; Vaginal Birth; Risk Prediction

Outcome Measures

Primary Outcomes (2)

• Numerical hierarchical composite score of postpartum morbidity and mortality at hospital discharge

  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

  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 Outcomes (37)

• Estimated blood loss <1000 mL

  Date of randomization up to 30 days postpartum

• Estimated blood loss >=1000 mL

  Date of randomization up to 30 days postpartum

• Mechanical treatment of hemorrhage

  Date of randomization up to 30 days postpartum

• Post-delivery packed red blood cell transfusion

  Date of randomization up to 30 days postpartum

• Uterine artery embolization

  Date of randomization up to 30 days postpartum

Study Arms (2)

Standard Care - Comparator Arm A

NO INTERVENTION

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.

Novel PPH Risk Prediction Model - Comparator Arm B

ACTIVE COMPARATOR

Standard Care with addition of a recently developed, novel PPH risk prediction model.

Behavioral: Novel PPH Risk Prediction Model - Comparator Arm B

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.

Novel PPH Risk Prediction Model - Comparator Arm B

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Holly Ende: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Holly Ende, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Ende, MD

CONTACT

615-322-8476; holly.ende@vumc.org

Tracie Baker, CCRP

CONTACT

615-875-1852; tracie.d.baker@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Model Details: Single Center Pragmatic Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 22, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)