NCT06513351 A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage
| NCT ID | NCT06513351 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Holly Ende |
| Condition | Post Partum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 12,500 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12,500 participants in total. It began in 2025-01-01 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Holly Ende, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT06513351 clinical trial?
This trial is open to female participants only, studying Post Partum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06513351 currently recruiting?
Yes, NCT06513351 is actively recruiting participants. Contact the research team at holly.ende@vumc.org for enrollment information.
Where is the NCT06513351 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06513351 clinical trial?
NCT06513351 is sponsored by Holly Ende. The principal investigator is Holly Ende, MD at Vanderbilt University Medical Center. The trial plans to enroll 12,500 participants.