Recruiting

Observational Study

Sponsor:

Holly Ende

Code:

NCT06513351

Conditions

Post Partum Hemorrhage

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Novel PPH Risk Prediction Model - Comparator Arm B

Study Details

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.

Conditions

Post Partum Hemorrhage

Study ID

NCT06513351

Start date

Jan 1, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Standard Care - Comparator Arm A

Standard Care, which includes a category-based risk assessment tool as part of nursing admission workflow. The prophylactic interventions in the intervention are recommended by the tool but not specifically tied to provider-facing clinical decision support.

active comparator: Novel PPH Risk Prediction Model - Comparator Arm B

Standard Care with addition of a recently developed, novel PPH risk prediction model.

Interventions

Novel PPH Risk Prediction Model - Comparator Arm B

Patients in this group will receive the standard care risk assessment with the addition of a recently developed, novel PPH risk prediction model, which will automatically calculate a patient's numerical risk of hemorrhage based on 21 risk factors. Elevated risk of hemorrhage (>=3% predicted risk), as predicted by the model, will be linked to clinical decision support, including a best practice advisory with recommendations presented to providers for consideration when they access the patient's electronic health record.

Primary outcome measure

  • Numerical hierarchical composite score of postpartum morbidity and mortality at hospital discharge [ Time Frame: Date of randomization to Postpartum hospital discharge (usually 2-4 days) ]
  • Numerical hierarchical composite score of postpartum morbidity and mortality at 30 days postpartum [ Time Frame: 30 days postpartum ]

Central Contacts and Locations

Central contacts

Holly Ende, MD

615-322-8476holly.ende@vumc.org

Tracie Baker, CCRP

615-875-1852tracie.d.baker@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Holly Ende, MD

615-322-8476holly.ende@vumc.org

Principal Investigator:

Holly Ende, MD

More Information

Sponsor

Holly Ende

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Post Partum Hemorrhage
  • Cesarean Section
  • Vaginal Birth
  • Risk Prediction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Holly Ende on 2026-07-22.