Optimization of Postpartum Thromboprophylaxis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05058924|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2021
Last Update Posted : September 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Drug: Prophylactic low molecular weight heparin Drug: Low molecular weight heparin and low-dose aspirin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single Center pilot feasibility RCT|
|Masking:||None (Open Label)|
|Official Title:||Optimization of Postpartum Thromboprophylaxis: is 6 Weeks Necessary?|
|Actual Study Start Date :||August 29, 2021|
|Estimated Primary Completion Date :||June 22, 2022|
|Estimated Study Completion Date :||June 22, 2022|
Active Comparator: Prophylactic Low Molecular Weight Heparin (LMWH)
Prophylactic LMWH for 6 weeks postpartum
Drug: 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.
Other Name: LMWH
Experimental: Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose Aspirin
Prophylactic LMWH for 3 weeks followed by low dose Aspirin for 3 weeks.
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.
- Enrollment Rate [ Time Frame: 1 year ]
- Consent Rate [ Time Frame: 1 year ]
- Adherence to Prescription [ Time Frame: 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).
- Withdrawal of consent rate [ Time Frame: 1 year ]
- Rates of contamination [ Time Frame: 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).
- VTE event rate [ Time Frame: 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 [ Time Frame: 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 Duke Anticoagulation Satisfaction Scale (DASS) [ Time Frame: 6 weeks ]The maximum value would be 65, indicating the worst quality of life. Minimum value would be 13, indicating best quality of life. This satisfaction assessment would be collected on dosing (day 1), 3 week follow up, 6 week follow up and if early discontinuation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058924
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1Z5|
|Principal Investigator:||Nadine Shehata, MD||Department of Medicine/IHPME, University of Toronto, Division of Hematology, Mount Sinai Hospital|
|Principal Investigator:||Evang Vlachodimitropoulou Koumoutsea, MBBS||Department of Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital|