Predicting the risk of postpartum hemorrhage during childbirth
Official title: Logistic Regression Prediction Model vs. Standard of Care for Prediction of Postpartum Hemorrhage - A Pragmatic Randomized Controlled Trial
Run by Vanderbilt University Medical Center · NCT06513351 · Data updated 2026-11-12
This study tests a new computer model that predicts the risk of heavy bleeding after childbirth to help doctors take better care of new moms.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 12500 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2028 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT06513351 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women undergoing vaginal or cesarean deliveries at Vanderbilt University Medical Center.
✕Probably not a fit
Patients who are discharged before delivery or those with a planned hysterectomy prior to delivery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research project aims to improve childbirth safety by utilizing advanced computer models to predict the risk of postpartum hemorrhage (PPH). The study compares a traditional risk assessment tool with a new model that evaluates 21 factors and updates in real-time during labor. If a patient's risk exceeds a certain threshold, a Best Practice Advisory (BPA) will alert clinicians to recommended interventions. The goal is to enhance perinatal outcomes by providing timely and evidence-based recommendations for at-risk patients.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postpartum hemorrhage and improve maternal health outcomes.
How similar studies have gone: Other studies have shown promise in using predictive modeling for similar conditions, indicating potential for success with this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Holly Ende, MD — Vanderbilt University Medical Center
- Study coordinator: Holly Ende, MD
- Email: holly.ende@vumc.org
- Phone: 615-322-8476
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating ultrasound to predict postpartum hemorrhage risk
This study is testing if ultrasound exams done shortly after delivery can help predict the risk of bleeding complications for new mothers in the hours following childbirth.
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Comparing carbetocin and oxytocin to prevent postpartum bleeding after cesarean delivery
This study is testing whether carbetocin works better than oxytocin to prevent heavy bleeding after a cesarean delivery in women who are at higher risk for this complication.
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Point-of-care hemoglobin testing during pregnancy
This project will test non-invasive and finger-prick devices to see if they give accurate, immediate hemoglobin readings for pregnant people during prenatal visits.
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Investigating how oxytocin works during cesarean deliveries
This study is testing how oxytocin works during scheduled cesarean deliveries to see if it helps prevent complications like uterine atony in new mothers.
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Using Tranexamic Acid to Prevent Postpartum Hemorrhage
This study is testing if Tranexamic Acid can help prevent heavy bleeding after childbirth in women having cesarean sections or vaginal deliveries.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.