Predicting the risk of postpartum hemorrhage during childbirth
Logistic Regression Prediction Model vs. Standard of Care for Prediction of Postpartum Hemorrhage - A Pragmatic Randomized Controlled Trial
NA · Vanderbilt University Medical Center · NCT06513351
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10000 (estimated) |
| Sex | Female |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06513351 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women undergoing vaginal or cesarean deliveries at Vanderbilt University Medical Center.
Not a fit: Patients who are discharged before delivery or those with a planned hysterectomy prior to delivery may not benefit from this study.
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 performed: Other studies have shown promise in using predictive modeling for similar conditions, indicating potential for success with this novel approach.
Eligibility criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Partum Hemorrhage, Cesarean Section, Vaginal Birth, Risk Prediction