ow molecular weight heparin (Fragmin) in pregnant women with a history of uteroplacental insufficiency and thrombophilia, a randomized trial - FRUIT
- Conditions
- Women with a history of pre-eclampsia and babies small for gestational age
- Registration Number
- EUCTR2005-005850-30-AT
- Lead Sponsor
- Medical University Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 262
Inclusion Criteria
Women wit a history of pre-eclampsia and babies small for gestational age before 34 weeks of gestation
Thrombophilia
Age >18 years
Informed consent
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
AT-deficiency, diabetes mellitus, known malignancy, gastroduodenal-ulcer, severe renal or hepatic insufficiency, thromboembolism in histoty, hemorrhagic diathesis, ITP
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To test whether Dalteparin improves the outcome of pregnancy;Secondary Objective: ;Primary end point(s): Recurrence of pre-eclampsia and small for gestational age babies
- Secondary Outcome Measures
Name Time Method