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Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04635839
Recruitment Status : Completed
First Posted : November 19, 2020
Results First Posted : April 28, 2023
Last Update Posted : April 28, 2023
Sponsor:
Information provided by (Responsible Party):
Thalia Wong, MD, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Pregnancy Related
Antepartum DVT
Interventions Drug: Standard Dose of Unfractionated Heparin
Drug: Gestational Age-Based Dose of Unfractionated Heparin
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Period Title: Overall Study
Started 22 24
Completed 21 24
Not Completed 1 0
Reason Not Completed
Delivered prior to second dose of heparin             1             0
Arm/Group Title Standard Dosing Gestational Age-Based Dosing Total
Hide Arm/Group Description

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
 Total of all reporting groups
Overall Number of Baseline Participants 21 24 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 21 participants 24 participants 45 participants
32
(28 to 36)
34
(31 to 38)
33
(28 to 37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 24 participants 45 participants
Female
21
 100.0%
24
 100.0%
45
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 24 participants 45 participants
Hispanic or Latino
9
  42.9%
12
  50.0%
21
  46.7%
Not Hispanic or Latino
11
  52.4%
12
  50.0%
23
  51.1%
Unknown or Not Reported
1
   4.8%
0
   0.0%
1
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 24 participants 45 participants
American Indian or Alaska Native
0
   0.0%
2
   8.3%
2
   4.4%
Asian
2
   9.5%
1
   4.2%
3
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   9.5%
3
  12.5%
5
  11.1%
White
5
  23.8%
11
  45.8%
16
  35.6%
More than one race
11
  52.4%
6
  25.0%
17
  37.8%
Unknown or Not Reported
1
   4.8%
1
   4.2%
2
   4.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 24 participants 45 participants
21 24 45
Gravida  
Median (Inter-Quartile Range)
Unit of measure:  Pregnancies
Number Analyzed 21 participants 24 participants 45 participants
2
(1 to 3)
2
(2 to 5)
2
(1 to 3)
Nulliparous  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 24 participants 45 participants
15
  71.4%
10
  41.7%
25
  55.6%
Gestational age at randomization  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 21 participants 24 participants 45 participants
30.3
(26.4 to 32.6)
30.4
(27.6 to 33.0)
30.3
(27.1 to 32.6)
Body mass index  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 21 participants 24 participants 45 participants
29.9
(27.6 to 33.2)
30.4
(27.6 to 33.0)
30.1
(27.4 to 33.1)
1.Primary Outcome
Title Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds).
Hide Description 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
Time Frame Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description:

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Overall Number of Participants Analyzed 21 24
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.8%
8
  33.3%
2.Secondary Outcome
Title Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism)
Hide Description [Not Specified]
Time Frame Assessed throughout hospitalization, an average length of 8 days, until 6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description:

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Overall Number of Participants Analyzed 21 24
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.8%
0
   0.0%
3.Secondary Outcome
Title Number of Participants Who Did Not Receive or Had a Delay of Neuraxial Anesthesia Due to Unfractionated Heparin
Hide Description [Not Specified]
Time Frame Assessed at time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description:

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Overall Number of Participants Analyzed 21 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants That Received General Anesthesia
Hide Description [Not Specified]
Time Frame Assessed at time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description:

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Overall Number of Participants Analyzed 21 24
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.8%
0
   0.0%
5.Secondary Outcome
Title Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin
Hide Description [Not Specified]
Time Frame Assessed at time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description:

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Overall Number of Participants Analyzed 21 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Maximum Anti-Factor Xa Level Measured
Hide Description [Not Specified]
Time Frame Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description:

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Overall Number of Participants Analyzed 21 24
Median (Inter-Quartile Range)
Unit of Measure: IU/mL
0.09
(0.09 to 0.09)
0.09
(0.09 to 0.11)
7.Secondary Outcome
Title Mode of Delivery
Hide Description [Not Specified]
Time Frame Assessed at time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant in Arm 1 (standard dosing) delivered at an outside hospital and mode of delivery is unavailable
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description:

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Overall Number of Participants Analyzed 20 24
Measure Type: Count of Participants
Unit of Measure: Participants
Vaginal delivery
6
  30.0%
4
  16.7%
Cesarean delivery
14
  70.0%
20
  83.3%
8.Secondary Outcome
Title Estimated Blood Loss From Delivery
Hide Description [Not Specified]
Time Frame Assessed at time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant in Arm 1 (standard dosing) delivered at an outside hospital and estimated blood loss is unavailable
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description:

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Overall Number of Participants Analyzed 20 24
Median (Inter-Quartile Range)
Unit of Measure: cc
654
(125 to 1344)
593
(505 to 905)
9.Secondary Outcome
Title Number of Participants That Received a Blood Transfusion
Hide Description [Not Specified]
Time Frame From time of delivery until 6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant in Arm 1 (standard dosing) delivered at an outside hospital and need for blood transfusion is unavailable
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description:

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Overall Number of Participants Analyzed 20 24
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
7
  29.2%
10.Secondary Outcome
Title Maximum Activated Partial Thromboplastin Clotting Time Levels Measured
Hide Description [Not Specified]
Time Frame Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description:

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
Overall Number of Participants Analyzed 21 24
Median (Inter-Quartile Range)
Unit of Measure: seconds
26.6
(23.0 to 29.6)
30.4
(7.4 to 37.5)
Time Frame Adverse event data was evaluated and collected from time of enrollment in study until 6 weeks after study completion, an average of 8 weeks.
Adverse Event Reporting Description Adverse events were routinely monitored and assessed for by the principal investigator through medical chart review.
 
Arm/Group Title Standard Dosing Gestational Age-Based Dosing
Hide Arm/Group Description

Standard dose of unfractionated heparin

Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours

Dose of unfractionated heparin based on trimester of pregnancy

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
All-Cause Mortality
Standard Dosing Gestational Age-Based Dosing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/24 (0.00%) 
Hide Serious Adverse Events
Standard Dosing Gestational Age-Based Dosing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/24 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Dosing Gestational Age-Based Dosing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/24 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Thalia Mok
Organization: University of California, Los Angeles
Phone: 310-794-7274
EMail: tmok@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Thalia Wong, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04635839    
Other Study ID Numbers: 20-001799
First Submitted: November 9, 2020
First Posted: November 19, 2020
Results First Submitted: February 7, 2023
Results First Posted: April 28, 2023
Last Update Posted: April 28, 2023