Status:
COMPLETED
Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Netherlands Organisation for Scientific Research
Aspen Pharma
Conditions:
Deep Venous Thrombosis
Pulmonary Embolism
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both...
Eligibility Criteria
Inclusion
- Age: 18 years or older, and;
- Pregnancy confirmed by urinary pregnancy test, and;
- Gestational age \< 14 weeks, and;
- Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma).
Exclusion
- Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor, or;
- Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy), or;
- Inability to provide informed consent, or;
- Any contraindication listed in the local labelling of LMWH.
Key Trial Info
Start Date :
April 24 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
1110 Patients enrolled
Trial Details
Trial ID
NCT01828697
Start Date
April 24 2013
End Date
October 31 2021
Last Update
May 26 2022
Active Locations (72)
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1
Weill Cornell Medicine | NewYork-Presbyterian
New York, New York, United States
2
KU Leuven
Leuven, Belgium
3
The Ottawa Hospital
Ottawa, Canada
4
Aalborg University Hospital
Aalborg, Denmark