Predicting Postpartum Hemorrhage Risk

This study is testing a new way to predict postpartum hemorrhage (PPH), which is heavy bleeding after childbirth. Currently, risk assessments are basic. This research will use a "Novel PPH Risk Prediction Model" that automatically calculates your risk based on 21 factors. If you are in the intervention group, your care team will also receive a "Best Practice Advisory" with recommended actions if your risk is high. The study wants to see if using this model improves outcomes for mothers. You can join if you are delivering at Vanderbilt University Medical Center. Researchers will look at your health at discharge and 30 days after delivery to see if the new model helps.

Study design
This is an interventional, randomized controlled trial planning to enroll 12,500 women. It compares standard care with standard care plus a new risk prediction model.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be followed until you leave the hospital (usually 2-4 days after delivery) and again at 30 days postpartum.

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NCT06513351

A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage

Recruiting
NAAll AgesInterventionalHealth services
Holly Ende
~12,500 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Novel PPH Risk Prediction Model - Comparator Arm B

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numerical hierarchical composite score of postpartum morbidity and mortality at hospital discharge
Measured over Date of randomization to Postpartum hospital discharge (usually 2-4 days)
+1 more outcome measured
Post Partum Hemorrhage
1 sites across 1 states
Tennessee1
  • Holly Ende, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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Eligibility criteria

Inclusion

All vaginal and cesarean deliveries occurring at Vanderbilt University Medical Center

Exclusion

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

  • Numerical hierarchical composite score of postpartum morbidity and mortality at 30 days postpartum30 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.