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NCT Number: NCT06513351

A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location status: Recruiting

Location contact

Holly Ende, MD

CONTACT

[email protected]

615-322-8476

Holly Ende, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Estimated blood loss <1000 mL

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients with estimated blood loss <1000mL

  2. Estimated blood loss >=1000 mL

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients with estimated blood loss >=1000mL

  3. 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)

  4. 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

  5. Uterine artery embolization

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who required uterine artery embolization

  6. Hysterectomy due to bleeding

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients requiring a hysterectomy due to bleeding

  7. Death

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who died within 30 days postpartum

  8. 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

  9. Estimated blood loss (mL)

    Time frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days)

    median and interquartile range for all patients

  10. 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

  11. 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

  12. Acute myocardial infarction

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced an acute myocardial infarction

  13. Aneurysm

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced an aneurysm

  14. Acute renal failure

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced acute renal failure

  15. Acute respiratory distress syndrome

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced acute respiratory distress syndrome

  16. Amniotic fluid embolism

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced amniotic fluid embolism

  17. Cardiac arrest/ventricular fibrillation

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced cardiac arrest/ventricular fibrillation

  18. Conversion of cardiac rhythm

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who required conversion of cardiac rhythm

  19. Disseminated intravascular coagulation

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced disseminated intravascular coagulation

  20. Blood transfusion

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who required a blood transfusion

  21. Eclampsia

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced eclampsia

  22. 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

  23. Puerperal cerebrovascular disorders

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced puerperal cerebrovascular disorders

  24. 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

  25. Severe anesthesia complications

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced severe anesthesia complications

  26. Sepsis

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced sepsis

  27. Shock

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced shock

  28. 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

  29. Air and thrombotic embolism

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who experienced air and thrombotic embolism

  30. Hysterectomy

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who required a hysterectomy

  31. Temporary tracheostomy

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who required a temporary tracheostomy

  32. Ventilation

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who required ventilation

  33. Post-delivery ICU admission

    Time frame: Date of randomization up to 30 days postpartum

    Number of patients who required ICU admission following delivery

  34. 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

  35. 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.

  36. 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.

  37. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Holly Ende, MD

CONTACT

[email protected]

615-322-8476

Tracie Baker, CCRP

CONTACT

[email protected]

615-875-1852

Sponsors and collaborators

Lead sponsor

Holly Ende

Other

Collaborators

  • Vanderbilt University Medical Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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