MedTrace Logo

Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)

NCT04635839 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-04-28

Study results available
· View outcomes & findings →

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.

Conditions

  • Pregnancy Related
  • Antepartum DVT

Interventions

DRUG

Standard Dose of Unfractionated Heparin

5,000 units subcutaneous unfractionated heparin every 12 hours

DRUG

Gestational Age-Based Dose of Unfractionated Heparin

* First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2022-03-31
Completion
2022-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635839 on ClinicalTrials.gov