Low Molecular Weight hEparin vs. Aspirin Post-partum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-29

Study Completion Date

2024-03-01

Brief Summary

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This is single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks at moderate to high risk of developing VTE.

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Detailed Description

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A single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks for women at moderate to high risk of developing VTE to determine feasibility of conducting a large non inferiority trial using the same regimens.

Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single Center pilot feasibility RCT

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prophylactic Low Molecular Weight Heparin (LMWH)

Prophylactic LMWH for 6 weeks postpartum

Group Type ACTIVE_COMPARATOR

Prophylactic low molecular weight heparin

Intervention Type DRUG

Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight \<100 kg for 6 weeks.

Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose Aspirin

Prophylactic LMWH for 3 weeks followed by low dose Aspirin for 3 weeks.

Group Type EXPERIMENTAL

Low molecular weight heparin and low-dose aspirin

Intervention Type DRUG

Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight \<100 kg for three weeks followed by ASA 81 mg orally daily for three weeks.

Interventions

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Prophylactic low molecular weight heparin

Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight \<100 kg for 6 weeks.

Intervention Type DRUG

Low molecular weight heparin and low-dose aspirin

Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight \<100 kg for three weeks followed by ASA 81 mg orally daily for three weeks.

Intervention Type DRUG

Other Intervention Names

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LMWH LMWH ASA

Eligibility Criteria

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Inclusion Criteria

1. Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation or
2. Family history (1st degree relative) of VTE and antithrombin deficiency, protein C or protein S deficiency or
3. Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (1st degree relative) and
4. \> 18 years of age.

Exclusion Criteria

1. Pre-existing indication for therapeutic LMWH
2. Contraindication to ASA:

1. Known ASA allergy
2. Documented history of gastrointestinal ulcer
3. Known platelet count \< 50x10\^9/L at any time during the current pregnancy or postpartum
3. Contraindication to LMWH, e.g. known allergy
4. Active bleeding at any site, excluding physiological vaginal bleeding
5. Patients with bleeding disorders
6. Known severe hypertension (SBP \>200mm/hg and/or DBP \>120mm/hg) during the current pregnancy or postpartum

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No