NCT04635839

Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)

Completed Phase 4 Results posted Last updated 28 April 2023

What this trial tests

Phase 4 trial testing Standard Dose of Unfractionated Heparin in Pregnancy Related in 46 participants. Completed in 1 May 2022.

Timeline

15 December 2020

Primary endpoint
31 March 2022

1 May 2022

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	46
Start date	15 December 2020
Primary completion	31 March 2022
Estimated completion	1 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Standard Dose of Unfractionated Heparin — full drug profile →
• Gestational Age-Based Dose of Unfractionated Heparin — full drug profile →

Conditions studied

• Pregnancy Related — all drugs for Pregnancy Related →
• Antepartum DVT — all drugs for Antepartum DVT →

Sponsor

University of California, Los Angeles

Who can join

Adults 18 to 50, female only, with Pregnancy Related or Antepartum DVT. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds). Primary · Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week

Surrogate marker for whether or not the patient would be eligible for neuraxial anesthesia based on guidelines for neuraxial anesthesia in pregnant women receiving VTE prophylaxis

Group	Value	95% CI
Standard Dosing	1
Gestational Age-Based Dosing	8

Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism) Secondary · Assessed throughout hospitalization, an average length of 8 days, until 6 weeks after delivery

Group	Value	95% CI
Standard Dosing	1
Gestational Age-Based Dosing	0

Number of Participants Who Did Not Receive or Had a Delay of Neuraxial Anesthesia Due to Unfractionated Heparin Secondary · Assessed at time of delivery

Group	Value	95% CI
Standard Dosing	0
Gestational Age-Based Dosing	0

Number of Participants That Received General Anesthesia Secondary · Assessed at time of delivery

Group	Value	95% CI
Standard Dosing	1
Gestational Age-Based Dosing	0

Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin Secondary · Assessed at time of delivery

Group	Value	95% CI
Standard Dosing	0
Gestational Age-Based Dosing	0

Maximum Anti-Factor Xa Level Measured Secondary · Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week

Group	Value	95% CI
Standard Dosing	0.09	0.09 – 0.09
Gestational Age-Based Dosing	0.09	0.09 – 0.11

Mode of Delivery Secondary · Assessed at time of delivery

Vaginal delivery

Group	Value	95% CI
Standard Dosing	6
Gestational Age-Based Dosing	4

Cesarean delivery

Group	Value	95% CI
Standard Dosing	14
Gestational Age-Based Dosing	20

Estimated Blood Loss From Delivery Secondary · Assessed at time of delivery

Group	Value	95% CI
Standard Dosing	654	125 – 1344
Gestational Age-Based Dosing	593	505 – 905

Number of Participants That Received a Blood Transfusion Secondary · From time of delivery until 6 weeks after delivery

Group	Value	95% CI
Standard Dosing	1
Gestational Age-Based Dosing	7

Maximum Activated Partial Thromboplastin Clotting Time Levels Measured Secondary · Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week

Group	Value	95% CI
Standard Dosing	26.6	23.0 – 29.6
Gestational Age-Based Dosing	30.4	7.4 – 37.5

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period.
   Middleton P, Shepherd E, Gomersall JC. · · 2021 · cited 43× · PMID 33779986 · DOI 10.1002/14651858.cd001689.pub4
2. Prophylactic Unfractionated Heparin in Antepartum Hospitalizations: A Randomized Controlled Trial.
   Mok T, Nguyen AV, Kwan L, Steinberg I, et al · · 2024 · cited 4× · PMID 38743958 · DOI 10.1097/aog.0000000000005599