ow molecular weight heparin (FRagmin (R)) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia, a randomized trial (FRUIT-study).
Recruiting
- Conditions
- The pregnant women are randomised after ultrasound confirmation of a viable intrauterine pregnancy to recieve daily dalteparin plus aspirin (starting before 12 weeks gestation) or aspirin only.
- Registration Number
- NL-OMON20780
- Lead Sponsor
- A single grant in the period 2000-2001 of Pharmacia and Upjohn.
- Brief Summary
This is the first trial with low molecular weight heparin in a population of women with a history of preeclampsia and will be submitted to an international journal.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 154
Inclusion Criteria
1. Patients with a history of preeclampsia and/or small for gestaitonal age infants before 34 weeks gestation and documented thrombophilia restricted to proteine c and proteine S deficiency, APC resistance, Factor V Leiden mutation, FActor II mutation, anticardiolipin antibodies, lupus anticoagulant;
2. Age > 18 years;
Exclusion Criteria
1. Antithrombine deficiency;
2. Diabetes mullitus;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of preeclampsia before 34 weeks gestational age.
- Secondary Outcome Measures
Name Time Method 1. Reduction in spontaneous abortion, maternal admission to hospital and neonatal intensive care admission;<br /><br>2. Increase in gestational age and weight at birth.