N/A N=13

Evaluation of Novel Point of Care Coagulation System in Pregnant Women

Hemorrhage · Coagulation Delay

Bottom Line

View on ClinicalTrials.gov: NCT04301193 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Correlation of Fibrinogen in mg/dL Concentration With Clot Strength (CS hPa) and Fibrinogen Contribution to Clot (FCS hPa) of Point of the Care Quantra System. — 494; 105; 137; 162 mg/dL — p=<0.05

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Quantra Analyzer (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Maryland, Baltimore
Primary completion: Jul 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Correlation of Fibrinogen in mg/dL Concentration With Clot Strength (CS hPa) and Fibrinogen Contribution to Clot (FCS hPa) of Point of the Care Quantra System.	32.8; 4.9; 6.4; 1.1; 8.5; 1.9	—
PRIMARY Correlation of Fibrinogen in mg/dL Concentration With Clot Strength (CS hPa) and Fibrinogen Contribution to Clot (FCS hPa) of Point of the Care Quantra System.	32.8; 4.9; 6.4; 1.1; 8.5; 1.9	—

Summary

In this study the investigators will evaluate a new point of care Quantra Hemostasis Analyzer system to assess coagulation rapidly with ease.

Eligibility Criteria

Inclusion Criteria

Pregnant woman at 37-41 weeks gestation

Exclusion Criteria

Hypertension
Preeclampsia
Gestational diabetes
Preexisting coagulopathy
History of deep vein thrombosis (DVT)
Medications that impair coagulation
History of pulmonary embolism or thrombosis
Women in active labor receiving intravenous fluids or oxytocin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04301193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.