ow molecular weight heparin (FRagmin®) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia: a randomised trial
Completed
- Conditions
- Pre-eclampsia, Small for Gestational Age (SGA)Pregnancy and ChildbirthPre-eclampsia
- Registration Number
- ISRCTN87325378
- Lead Sponsor
- VU University Medical Center (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 154
Inclusion Criteria
1. Patients with a history of preeclampsia and/or small for gestational age infants before 34 weeks gestation and documented thrombophilia restricted to protein C and protein S deficiency, Activated Protein C (APC) resistance, Factor V Leiden mutation, Factor II mutation, anticardiolipin antibodies, lupus anticoagulant
2. Aged greater than 18 years
3. Informed consent
Exclusion Criteria
1. Antithrombin deficiency
2. Diabetes mellitus
3. Known malignancy
4. Gastro-duodenic ulcer
5. Severe renal or hepatic insufficiency
6. Thrombo-embolism in history
7. Hemorrhagic diathesis
8. Idiopathic thrombocytopenia
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>2. Increase in gestational age and weight at birth