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NCT06513351 · ClinicalTrials.gov registry record · NA

A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage

A NA study of Post Partum Hemorrhage, sponsored by Holly Ende.

Recruiting
Registry status
NA
Development phase
10,000
Enrollment target
1
Study location

NCT06513351 is a NA study of Post Partum Hemorrhage that is actively recruiting participants, run by Holly Ende. The registered enrollment target is 10,000 participants, above the 368-participant average among 7 other Post Partum Hemorrhage trials with a reported enrollment target (2617% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT06513351, a NA study of Post Partum Hemorrhage, is actively recruiting participants, sponsored by Holly Ende.

RECRUITING
Registry status
NA
Development phase
10,000 participants
Enrollment target
1
Study location

Study 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 Studied

Post Partum Hemorrhage

Interventions

  • BEHAVIORAL Novel PPH Risk Prediction Model - Comparator Arm B

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 10,000 participants
Start Date 2025-01-01
Est. Completion 2027-07
Phase NA

Sponsor

Holly Ende

1 total trials

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What the Registry Record Tells You About NCT06513351

The ClinicalTrials.gov registry entry for NCT06513351 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 368-participant average among 7 other Post Partum Hemorrhage trials with a reported enrollment target (2617% higher). The listed sponsor is Holly Ende, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Post Partum Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which Novel PPH Risk Prediction Model - Comparator Arm B is the first listed.

NCT06513351 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT06513351 about?

NCT06513351 is a clinical study titled "A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage". 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. T...

What is the current status of trial NCT06513351?

This trial is currently recruiting. It is a NA study. The enrollment target is 10,000 participants. The study started on 2025-01-01. Estimated completion is 2027-07.

What conditions does trial NCT06513351 study?

This clinical trial studies the following conditions: Post Partum Hemorrhage.

What interventions are being tested in trial NCT06513351?

The interventions under investigation include: Novel PPH Risk Prediction Model - Comparator Arm B (BEHAVIORAL).

Who is sponsoring clinical trial NCT06513351?

This trial is sponsored by Holly Ende, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06513351 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.