Highlow study.
Recruiting
- Conditions
- To evaluate the efficacy and safety of intermediate dose LMWH versus fixed low dose LMWH in pregnant women with a history of previous deep venous thrombosis or pulmonary embolism.
- Registration Number
- NL-OMON23452
- Lead Sponsor
- Academic Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
1. Age > 18 years;
2. Pregnancy confirmed by urinary pregnancy test;
Exclusion Criteria
1. 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;
2. Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Symptomatic DVT during pregnancy and 6 weeks postpartum;<br /><br>2. Symptomatic PE during pregnancy and 6 weeks postpartum.
- Secondary Outcome Measures
Name Time Method 1. Symptomatic DVT during pregnancy until 3 months postpartum;<br /><br>2. Symptomatic PE during pregnancy until 3 months postpartum.