CompletedNot Applicable

Evaluation of Novel Point of Care Coagulation System in Pregnant Women

United States13 participantsStarted 2019-11-01

Plain-language summary

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

Who can participate

Age range18 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

1

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.

Timeframe: Baseline: This is invitro study of the blood obtained from pregnant women (base line). This is a non-interventional observational study. Baseline samples were diluted and reconstituted and were analyzed on the same day within 4 hours of preparation.

2

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.

Timeframe: Baseline: This is invitro study of the blood obtained from pregnant women (base line). This is a non-interventional observational study. Baseline samples were diluted and reconstituted and were analyzed on the same day

Trial details

NCT IDNCT04301193

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-07-31

Results submitted2022-01-14