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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.
Venous thromboembolism is one of the leading causes of maternal morbidity and mortality, and antepartum hospitalizations place pregnant patients at an even higher risk of developing thromboembolism. As a result, there is an increased emphasis on administering pharmacologic thromboprophylaxis for antepartum patients with prolonged hospitalizations. Previously, standard dosing of unfractionated heparin was widely adopted for thromboprophylaxis in the pregnant population. However, due to a suspected altered metabolism of unfractionated heparin in pregnancy resulting in a decrease response, the American College of Obstetricians and Gynecologists (ACOG) currently recommends considering gestational age-based dosing for unfractionated heparin for thromboprophylaxis in pregnancy with standard dosing as an alternative option. The data supporting altered dosing is very limited. In addition, increased dosing of heparin may result in challenges in anesthetic management, potentially limiting the receipt of neuraxial anesthesia resulting in increased need for general anesthesia associated with both increased maternal and fetal risks. The potential effects of higher prophylactic unfractionated heparin dosing in pregnant patients need to be further explored before being widely adopted for inpatient antepartum thromboprophylaxis. The investigators propose this study to provide a direct comparison of gestational age-based unfractionated heparin dosing to standard dosing of unfractionated heparin for pharmacologic thromboprophylaxis of hospitalized antepartum patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dosing | Active Comparator | Standard dose of unfractionated heparin |
|
| Gestational Age-Based Dosing | Active Comparator | Dose of unfractionated heparin based on trimester of pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Dose of Unfractionated Heparin | Drug | 5,000 units subcutaneous unfractionated heparin every 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds). | 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 | Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism) | Assessed throughout hospitalization, an average length of 8 days, until 6 weeks after delivery | |
| Number of Participants Who Did Not Receive or Had a Delay of Neuraxial Anesthesia Due to Unfractionated Heparin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38743958 | Derived | Mok T, Nguyen AV, Kwan L, Steinberg I, Vallera C, Silverman NS, Rao R. Prophylactic Unfractionated Heparin in Antepartum Hospitalizations: A Randomized Controlled Trial. Obstet Gynecol. 2024 Jul 1;144(1):118-125. doi: 10.1097/AOG.0000000000005599. Epub 2024 May 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dosing | Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours |
| FG001 | 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
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dosing | Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours |
| BG001 | Gestational Age-Based Dosing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds). | 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 | Posted | Count of Participants | Participants | Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week |
|
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 events were routinely monitored and assessed for by the principal investigator through medical chart review.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Dosing | Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thalia Mok | University of California, Los Angeles | 310-794-7274 | tmok@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2020 | Apr 26, 2023 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2022 | Apr 26, 2023 | SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2021 | Apr 26, 2023 | ICF_006.pdf |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Gestational Age-Based Dose of Unfractionated Heparin | Drug |
|
|
| Assessed at time of delivery |
| Number of Participants That Received General Anesthesia | Assessed at time of delivery |
| Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin | Assessed at time of delivery |
| Maximum Anti-Factor Xa Level Measured | Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week |
| Mode of Delivery | Assessed at time of delivery |
| Estimated Blood Loss From Delivery | Assessed at time of delivery |
| Number of Participants That Received a Blood Transfusion | From time of delivery until 6 weeks after delivery |
| Maximum Activated Partial Thromboplastin Clotting Time Levels Measured | Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gravida | Median | Inter-Quartile Range | pregnancies |
|
| Nulliparous | Count of Participants | Participants |
|
| Gestational age at randomization | Median | Inter-Quartile Range | weeks |
|
| Body mass index | Median | Inter-Quartile Range | kg/m^2 |
|
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
|
|
| Secondary | Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism) | Posted | Count of Participants | Participants | Assessed throughout hospitalization, an average length of 8 days, until 6 weeks after delivery |
|
|
|
| Secondary | Number of Participants Who Did Not Receive or Had a Delay of Neuraxial Anesthesia Due to Unfractionated Heparin | Posted | Count of Participants | Participants | Assessed at time of delivery |
|
|
|
| Secondary | Number of Participants That Received General Anesthesia | Posted | Count of Participants | Participants | Assessed at time of delivery |
|
|
|
| Secondary | Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin | Posted | Count of Participants | Participants | Assessed at time of delivery |
|
|
|
| Secondary | Maximum Anti-Factor Xa Level Measured | Posted | Median | Inter-Quartile Range | IU/mL | Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week |
|
|
|
| Secondary | Mode of Delivery | 1 participant in Arm 1 (standard dosing) delivered at an outside hospital and mode of delivery is unavailable | Posted | Count of Participants | Participants | Assessed at time of delivery |
|
|
|
| Secondary | Estimated Blood Loss From Delivery | 1 participant in Arm 1 (standard dosing) delivered at an outside hospital and estimated blood loss is unavailable | Posted | Median | Inter-Quartile Range | cc | Assessed at time of delivery |
|
|
|
| Secondary | Number of Participants That Received a Blood Transfusion | 1 participant in Arm 1 (standard dosing) delivered at an outside hospital and need for blood transfusion is unavailable | Posted | Count of Participants | Participants | From time of delivery until 6 weeks after delivery |
|
|
|
| Secondary | Maximum Activated Partial Thromboplastin Clotting Time Levels Measured | Posted | Median | Inter-Quartile Range | seconds | Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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
| 0 | 24 | 0 | 24 | 0 | 24 |
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