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Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)

About

Brief Summary

This study is a randomized control trial to compare gestational age-based dosing with standard dosing of unfractionated heparin for thromboprophylaxis of hospitalized antepartum patients. The investigators aim to determine the effect of dosing on receipt of neuraxial anesthesia and pregnancy outcomes and evaluate the pharmacokinetics and pharmacodynamics of unfractionated heparin in pregnancy.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
Female
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
50 Years

Inclusion Criteria:

  • At least 18 years of age
  • Speak English or Spanish
  • Antepartum admission for at least 72 hours at Ronald Reagan UCLA Medical Center
  • Provides informed consent for study participation

Exclusion Criteria:

  • Active or threatened antenatal bleeding
  • Disseminated intravascular coagulation
  • Risk of imminent delivery (delivery within 12 hours)
  • Thrombocytopenia (platelet count < 100 x 109)
  • Elevated baseline aPTT (> 36.2 seconds)
  • Concern for hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome
  • Congenital bleeding disorders (hemophilias)
  • Receiving therapeutic or prophylactic anticoagulation (unfractionated heparin, low molecular weight heparin, oral anticoagulants) for alternative indication (e.g., acquired or inherited thrombophilia, history of VTE)
  • History of heparin-induced thrombocytopenia (HIT)
  • SARS-CoV-2 positive
  • Cognitive impairment, psychiatric instability, or language barriers that limit their ability to provide informed consent
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

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Study Stats
Protocol No.
20-001799
Category
Obstetrics & Gynecology
Contact
Thalia Wong
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04635839
For detailed technical eligibility, visit ClinicalTrials.gov.