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NCT06513351 · ClinicalTrials.gov registry record · NA
A Pragmatic Randomized Controlled Trial to Predict Postpartum Hemorrhage
A NA study of Postpartum Hemorrhage, sponsored by Holly Ende.
- Recruiting
- Registry status
- NA
- Development phase
- 10,000
- Enrollment target
- 1
- Study location
NCT06513351: Recruiting NA study of Postpartum Hemorrhage, sponsored by Holly Ende.
NCT06513351 is a NA study of Postpartum Hemorrhage that is actively recruiting participants, run by Holly Ende. The registered enrollment target is 10,000 participants, above the 254-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (3837% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06513351, a NA study of Postpartum 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.
Primary Outcome
Patients will be assigned the most severe morbidity and mortality outcome score based on a range of criteria from 1 to 7 with 1 being the least severe and 7 being the most severe outcome. 1 is Estimated blood loss \<1000 mL, 2 is Estimated blood loss \>=1000 mL, 3 is Mechanical treatment of hemorrhage (uterine tamponade device insertion, uterine compression suture), 4 is Post-delivery red blood cell transfusion, 5 is Uterine artery embolization, 6 is Hysterectomy due to bleeding, and 7 is Death.
Conditions Studied
Interventions
- BEHAVIORAL Novel PPH Risk Prediction Model - Comparator Arm B
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,000 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2027-07 |
| Phase | NA |
What NCT06513351 shows while recruiting
NCT06513351 is an interventional study that assigns participants to a tested intervention. Its 10,000 participants enrollment target places it among the larger protocols in the corpus, above the 254-participant average among 19 other Postpartum Hemorrhage trials with a reported enrollment target (3837% higher).
The record links to 1 condition, with Postpartum 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 a single indexed study location in 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: Postpartum 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.
Learn More About Clinical Trials
Similar trials for Postpartum Hemorrhage
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06513351's enrollment target sits among peer trials
10,000 1st of 19 higher than 19 of 19 other Postpartum Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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