Low Molecular Weight hEparin vs. Aspirin Post-partum

Not Applicable

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Prophylactic low molecular weight heparin; Drug: Low molecular weight heparin and low-dose aspirin

• Registration Number: NCT05058924
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-08-25
• Study Start: 2021-08-29
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-28
• Status Verified: 2023-05
• Primary Completion: 2024-02-29
• Study Completion: 2024-03-01
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic Low Molecular Weight Heparin (LMWH)	Prophylactic low molecular weight heparin	Prophylactic LMWH for 6 weeks postpartum
Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose Aspirin	Low molecular weight heparin and low-dose aspirin	Prophylactic LMWH for 3 weeks followed by low dose Aspirin for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Enrollment Rate	1 year
Withdrawal of consent rate	1 year
Rates of contamination	6 weeks	List of the concurrent medication will be gathered on 3 week follow up, 6 week follow up and early discontinuation (before 6 weeks).
Consent Rate	1 year
Adherence to Prescription	6 weeks	Utilization of co-interventions for both: control group (6 week of Low Molecular Weight Heparin) or Treatment group (3 week of low molecular weight Heparin and 3 week of low dose aspirin).

Secondary Outcome Measures

Name	Time	Method
VTE event rate	3 months	VTE must be confirmed either by Doppler ultrasound or V/Q scan or computer tomography (CT). Imaging will not be performed on all patients, only those with symptoms of VTE event. Event rate of VTE will be calculated by number of VTE events by Total days in this study. This number of VTE event is collected during 3 week follow up, 6 week follow up, 3 months follow-up and on early discontinuation date (before 3 months follow up). At the end of the study (after 3 month), the total VTE event rate is calculated.
Bleeding assessment six weeks following delivery	6 weeks	According to the International Society on Thrombosis and Hemostasis (ISTH) scoring system. The bleeding assessments are collected on 3 week phone call and 6 week phone call or early discontinuation visit (before 6 week follow up)
Anticoagulation Satisfaction Assessment using the PACT Scale	6 weeks

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada