History of Changes for Study: NCT04635839

Heparin Dosing for Thromboprophylaxis of Hospitalized Antepartum Patients

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Study Record Versions

Version	Submitted Date	Changes
1	November 13, 2020	None (earliest Version on record)
2	November 19, 2020	Study Identification and Study Status
3	January 25, 2021	Recruitment Status, Study Status, Contacts/Locations and Oversight
4	May 16, 2022	Recruitment Status, Study Status, Contacts/Locations and Study Design
5	June 29, 2022	Study Status, Study Design and Oversight
6	February 7, 2023	Quality Control Review has not concluded Returned: March 6, 2023 Outcome Measures, Study Status, Document Section
7	March 15, 2023	Quality Control Review has not concluded Returned: April 7, 2023 Document Section, Outcome Measures, Adverse Events, Baseline Characteristics, Study Status
8	April 26, 2023	Study Status, Document Section

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	20-001799
Brief Title:	Heparin Dosing for Thromboprophylaxis of Hospitalized Antepartum Patients
Official Title:	Randomized Control Trial of Unfractionated Heparin Dosing for Thromboprophylaxis of Hospitalized Antepartum Patients
Secondary IDs:

Study Status


Record Verification:	November 2020
Overall Status:	Not yet recruiting
Study Start:	November 15, 2020
Primary Completion:	May 1, 2022 [Anticipated]
Study Completion:	July 1, 2022 [Anticipated]

First Submitted:	November 9, 2020
First Submitted that Met QC Criteria:	November 13, 2020
First Posted:	November 19, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	November 13, 2020
Last Update Posted:	November 19, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	University of California, Los Angeles
Responsible Party:	Principal Investigator Investigator: Thalia Wong, MD Official Title: Co-Principal Investigator Affiliation: University of California, Los Angeles
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief 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. 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.

Conditions


Conditions:	Pregnancy Related Antepartum DVT
Keywords:	Thromboprophylaxis Antepartum admission Heparin

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	46 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: Standard Dosing Standard dose of unfractionated heparin	Drug: Standard Dose of Unfractionated Heparin 5,000 units subcutaneous unfractionated heparin every 12 hours
Active Comparator: Gestational Age-Based Dosing Dose of unfractionated heparin based on trimester of pregnancy	Drug: 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

Outcome Measures


Primary Outcome Measures:
1.	Elevated serum aPTT value above the normal range (> 36.2 seconds). [ Time Frame: From date of randomization through study completion, average 4 weeks ] 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
Secondary Outcome Measures:
1.	Diagnosis of venous thromboembolism (pulmonary embolism and/or deep venous thromboembolism) [ Time Frame: From date of randomization up to 6 weeks postpartum ]
2.	Nonreceipt or delay of neuraxial anesthesia due to unfractionated heparin [ Time Frame: From date of randomization through study completion, average 4 weeks ]
3.	Receipt of general anesthesia due to unfractionated heparin [ Time Frame: From date of randomization through study completion, average 4 weeks ]
4.	Delay in timing of delivery due to unfractionated heparin [ Time Frame: From date of randomization through study completion, average 4 weeks ]
5.	Anti-Xa levels [ Time Frame: From date of randomization through study completion, average 4 weeks ]
6.	Number of times adjustment in unfractionated heparin dose made [ Time Frame: From date of randomization through study completion, average 4 weeks ]
7.	Mode of delivery [ Time Frame: From date of randomization until date of delivery ]
8.	Estimated blood loss from delivery [ Time Frame: From date of randomization until 6 weeks postpartum ]
9.	Receipt of blood transfusion [ Time Frame: From date of randomization until 6 weeks postpartum ]

Eligibility


Minimum Age:	18 Years
Maximum Age:	50 Years
Sex:	Female
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Contacts/Locations


Central Contact Person:	Thalia Wong, MD Telephone: 310-210-2246 Email: thaliawong@mednet.ucla.edu
Locations:

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: