๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-20

A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage (NCT06513351)

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

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: Holly Ende

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Vanderbilt University Medical Center โ€” Nashville, Tennessee

๐Ÿงช Interventions in This Study

  • Novel PPH Risk Prediction Model - Comparator Arm B (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Vanderbilt University Medical Center โ€” Nashville, Tennessee

๐Ÿ“ž Contact the Study Coordinator

Phone: (615) 322-8476

Email: holly.ende@vumc.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—