Trial Outcomes & Findings for Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE) (NCT NCT04635839)
NCT ID: NCT04635839
Last Updated: 2023-04-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
Results posted on
2023-04-28
Participant Flow
Participant milestones
| Measure |
Standard Dosing
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
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 Study
STARTED
|
22
|
24
|
|
Overall Study
COMPLETED
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Standard Dosing
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
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 Study
Delivered prior to second dose of heparin
|
1
|
0
|
Baseline Characteristics
Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)
Baseline characteristics by cohort
| Measure |
Standard Dosing
n=21 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=99 Participants
|
34 years
n=107 Participants
|
33 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
24 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Gravida
|
2 pregnancies
n=99 Participants
|
2 pregnancies
n=107 Participants
|
2 pregnancies
n=206 Participants
|
|
Nulliparous
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Gestational age at randomization
|
30.3 weeks
n=99 Participants
|
30.4 weeks
n=107 Participants
|
30.3 weeks
n=206 Participants
|
|
Body mass index
|
29.9 kg/m^2
n=99 Participants
|
30.4 kg/m^2
n=107 Participants
|
30.1 kg/m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 weekSurrogate 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
Outcome measures
| Measure |
Standard Dosing
n=21 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
|
|---|---|---|
|
Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds).
|
1 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Assessed throughout hospitalization, an average length of 8 days, until 6 weeks after deliveryOutcome measures
| Measure |
Standard Dosing
n=21 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
|
|---|---|---|
|
Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at time of deliveryOutcome measures
| Measure |
Standard Dosing
n=21 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
|
|---|---|---|
|
Number of Participants Who Did Not Receive or Had a Delay of Neuraxial Anesthesia Due to Unfractionated Heparin
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at time of deliveryOutcome measures
| Measure |
Standard Dosing
n=21 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
|
|---|---|---|
|
Number of Participants That Received General Anesthesia
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at time of deliveryOutcome measures
| Measure |
Standard Dosing
n=21 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
|
|---|---|---|
|
Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 weekOutcome measures
| Measure |
Standard Dosing
n=21 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
|
|---|---|---|
|
Maximum Anti-Factor Xa Level Measured
|
0.09 IU/mL
Interval 0.09 to 0.09
|
0.09 IU/mL
Interval 0.09 to 0.11
|
SECONDARY outcome
Timeframe: Assessed at time of deliveryPopulation: 1 participant in Arm 1 (standard dosing) delivered at an outside hospital and mode of delivery is unavailable
Outcome measures
| Measure |
Standard Dosing
n=20 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
|
|---|---|---|
|
Mode of Delivery
Vaginal delivery
|
6 Participants
|
4 Participants
|
|
Mode of Delivery
Cesarean delivery
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Assessed at time of deliveryPopulation: 1 participant in Arm 1 (standard dosing) delivered at an outside hospital and estimated blood loss is unavailable
Outcome measures
| Measure |
Standard Dosing
n=20 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
|
|---|---|---|
|
Estimated Blood Loss From Delivery
|
654 cc
Interval 125.0 to 1344.0
|
593 cc
Interval 505.0 to 905.0
|
SECONDARY outcome
Timeframe: From time of delivery until 6 weeks after deliveryPopulation: 1 participant in Arm 1 (standard dosing) delivered at an outside hospital and need for blood transfusion is unavailable
Outcome measures
| Measure |
Standard Dosing
n=20 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
|
|---|---|---|
|
Number of Participants That Received a Blood Transfusion
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 weekOutcome measures
| Measure |
Standard Dosing
n=21 Participants
Standard dose of unfractionated heparin
Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours
|
Gestational Age-Based Dosing
n=24 Participants
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
|
|---|---|---|
|
Maximum Activated Partial Thromboplastin Clotting Time Levels Measured
|
26.6 seconds
Interval 23.0 to 29.6
|
30.4 seconds
Interval 7.4 to 37.5
|
Adverse Events
Standard Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gestational Age-Based Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place