Pregnancy RelatedPhase 4NCT04635839
Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)
A Phase 4 study testing Standard Dose of Unfractionated Heparin and Gestational Age-Based Dose of Unfractionated Heparin in people with Pregnancy Related and Antepartum DVT, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Antepartum DVT
- What is being tested?
- Standard Dose of Unfractionated Heparin and Gestational Age-Based Dose of Unfractionated Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 1 May 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 18 years of age
- Speak English or Spanish
- Antepartum admission for at least 72 hours at Ronald Reagan UCLA Medical Center
- Provides informed consent for study participation
Who cannot join
- Active or threatened antenatal bleeding
- Disseminated intravascular coagulation
- Risk of imminent delivery (delivery within 12 hours)
- Thrombocytopenia (platelet count < 100 x 109)
- Elevated baseline aPTT (> 36.2 seconds)
- Concern for hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome
Show all 12Show fewer
- Congenital bleeding disorders (hemophilias)
- Receiving therapeutic or prophylactic anticoagulation (unfractionated heparin, low molecular weight heparin, oral anticoagulants) for alternative indication (e.g., acquired or inherited thrombophilia, history of VTE)
- History of heparin-induced thrombocytopenia (HIT)
- SARS-CoV-2 positive
- Cognitive impairment, psychiatric instability, or language barriers that limit their ability to provide informed consent
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Unfractionated Heparin Thromboprophylaxis Dosing for Antepartum Hospitalizations
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.
Read the detailed description
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.
- Conditions
- Pregnancy Related, Antepartum DVT
- Being tested
- Standard Dose of Unfractionated Heparin, Gestational Age-Based Dose of Unfractionated Heparin
- Keywords
- Thromboprophylaxis, Antepartum admission, Heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Dose of Unfractionated HeparinDrug
5,000 units subcutaneous unfractionated heparin every 12 hours
Gestational Age-Based Dose of Unfractionated HeparinDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Standard Dosing | Active comparator | Standard dose of unfractionated heparin Receives: Drug: Standard Dose of Unfractionated Heparin |
| Gestational Age-Based Dosing | Active comparator | Dose of unfractionated heparin based on trimester of pregnancy Receives: Drug: Gestational Age-Based Dose of Unfractionated Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
Secondary outcomes (9)
Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism)
Measured: 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
Measured: Assessed at time of delivery
Number of Participants That Received General Anesthesia
Measured: Assessed at time of delivery
Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin
Measured: Assessed at time of delivery
Maximum Anti-Factor Xa Level Measured
Measured: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
Mode of Delivery
Measured: Assessed at time of delivery
Estimated Blood Loss From Delivery
Measured: Assessed at time of delivery
Number of Participants That Received a Blood Transfusion
Measured: From time of delivery until 6 weeks after delivery
Maximum Activated Partial Thromboplastin Clotting Time Levels Measured
Measured: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start15 Dec 2020
- Primary completion31 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thalia Wong, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635839
- Sponsor's protocol ID
- 20-001799
- Status last verified
- Apr 2023
- First submitted
- 9 Nov 2020
- Last updated
- 28 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 38743958
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Unfractionated Heparin Thromboprophylaxis Dosing for Antepartum Hospitalizations
- ClinicalTrials.gov ID
- NCT04635839
- Acronym / sponsor ID
- 20-001799
- Conditions
- Pregnancy Related, Antepartum DVT
- Keywords
- Thromboprophylaxis, Antepartum admission, Heparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Posted 28 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dosing | Active comparator | Drug: Standard Dose of Unfractionated HeparinStandard dose of unfractionated heparin |
| Gestational Age-Based Dosing | Active comparator | Drug: Gestational Age-Based Dose of Unfractionated HeparinDose of unfractionated heparin based on trimester of pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Speak English or Spanish
- Antepartum admission for at least 72 hours at Ronald Reagan UCLA Medical Center
- Provides informed consent for study participation
Key exclusion criteria (12 listed)
- Active or threatened antenatal bleeding
- Disseminated intravascular coagulation
- Risk of imminent delivery (delivery within 12 hours)
- Thrombocytopenia (platelet count < 100 x 109)
- Elevated baseline aPTT (> 36.2 seconds)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Dose of Unfractionated Heparin5,000 units subcutaneous unfractionated heparin every 12 hours | Drug | Standard Dosing |
| 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 | Drug | Gestational Age-Based Dosing |
Primary outcome
Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds).
Time frame: 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
9 secondary outcomes
Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism)
Time frame: 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
Time frame: Assessed at time of delivery
Number of Participants That Received General Anesthesia
Time frame: Assessed at time of delivery
Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin
Time frame: Assessed at time of delivery
Maximum Anti-Factor Xa Level Measured
Time frame: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
Mode of Delivery
Time frame: Assessed at time of delivery
Estimated Blood Loss From Delivery
Time frame: Assessed at time of delivery
Number of Participants That Received a Blood Transfusion
Time frame: From time of delivery until 6 weeks after delivery
Maximum Activated Partial Thromboplastin Clotting Time Levels Measured
Time frame: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38743958Mok 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Dose of Unfractionated Heparin and Gestational Age-Based Dose of Unfractionated Heparin in people with Pregnancy Related and Antepartum DVT, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds). (time frame: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04635839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.