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Behavioral Intervention

Risk Prediction Model for Postpartum Hemorrhage

N/A

Waitlist Available

Led By Holly Ende, MD

Research Sponsored by Holly Ende

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Patients with a pre-delivery planned hysterectomy (for placenta increta or percreta) will be excluded from the treatment algorithm and primary analysis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use advanced computer models to predict the risk of postpartum hemorrhage (PPH) during childbirth. The study will compare a new prediction model, which calculates risk based on

Who is the study for?

This trial is for pregnant individuals at risk of postpartum hemorrhage (PPH). Participants should be giving birth where the study is being conducted. There are no specific inclusion or exclusion criteria provided, but typically participants would need to be of childbearing age and not have conditions that could interfere with the study.

What is being tested?

The trial tests a new computer model predicting PPH against current basic tools. It uses 21 factors to assess risk in real-time during labor, providing instant recommendations if there's an increased risk.

What are the potential side effects?

Since this trial involves data analysis rather than medical treatments, direct side effects from interventions aren't expected. However, stress or anxiety related to monitoring outcomes may occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not planning a hysterectomy before delivery for placenta issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Numerical hierarchical composite score of postpartum morbidity and mortality at 30 days postpartum

Numerical hierarchical composite score of postpartum morbidity and mortality at hospital discharge

Secondary study objectives

Acute myocardial infarction

Acute renal failure

Acute respiratory distress syndrome

+34 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Novel PPH Risk Prediction Model - Comparator Arm BActive Control1 Intervention

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

Group II: Standard Care - Comparator Arm AActive Control1 Intervention

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.

0 / 1Eligibility criteria met