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Search / Trial NCT06513351

A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage

Launched by HOLLY ENDE · Jul 16, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Post Partum Hemorrhage Cesarean Section Vaginal Birth Risk Prediction

ClinConnect Summary

This clinical trial is exploring a new way to predict and prevent postpartum hemorrhage (PPH), which is excessive bleeding after childbirth that can be very serious for mothers. The study aims to improve the safety of childbirth by using advanced computer models that consider various factors to better assess the risk of PPH. By comparing a traditional risk assessment tool with this new model, the researchers hope that the enhanced approach will lead to better outcomes for mothers and their babies.

If you are a woman planning to give birth at Vanderbilt University Medical Center, you may be eligible to participate in this study. The trial includes all women who have vaginal or cesarean deliveries, while those who have specific pre-planned surgeries or are discharged before delivery won't be included. Participants will be randomly assigned to one of the two methods for predicting PPH, and the goal is to see if the new model can help healthcare providers make better decisions during labor to improve overall care. Your involvement could help shape future practices and enhance the safety of childbirth for many women.

Gender

FEMALE

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.

About Holly Ende

Holly Ende is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on ethical practices and rigorous scientific methodologies, Holly Ende collaborates with leading research institutions and healthcare professionals to develop and evaluate new therapies across various therapeutic areas. The organization emphasizes transparency, stakeholder engagement, and adherence to regulatory standards, ensuring the highest quality in trial management and execution. By fostering partnerships and leveraging cutting-edge technologies, Holly Ende aims to accelerate the development of safe and effective treatments that meet the evolving needs of patients and healthcare providers.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Holly Ende, MD

Principal Investigator

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported