EUCTR2012-001505-24-NLActive, not recruitingPhase 1
Highlow studyLow-molecular-weight heparin to prevent recurrent VTE in pregnancy: a randomized controlled trial of two doses - Highlow study
Academic Medical Center0 sites790 target enrollmentStarted: November 26, 2012Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 790
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •-Age = 18 years
- •-Pregnancy confirmed by urinary pregnancy test, gestational age < 14 weeks since first day of last menstrual period
- •-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)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 850
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •-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
- •-Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy)
- •-Inability to provide informed consent
- •-Any contraindication listed in the local labelling of LMWH
Investigators
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