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.
Conditions
Interventions
Two armed study:
A: Daily dalteparin (starting between 6-12 weeks pregnancy) throughout gestation plus aspirin (starting before 12 weeks gestation to 36 weeks)
B: Aspirin only ( starting before 12 weeks to 36 weeks).
Both arms receive regular controls for women with a history of preeclampsia. In arm A: examination of Anti FActor Xa activity at 20 and 30 wee
Sponsors
A single grant in the period 2000-2001 of Pharmacia and Upjohn.
Eligibility
Inclusion criteria
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; 3. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Antithrombine deficiency; 2. Diabetes mullitus; 3. Known malignancy; 4. Gastro-duodenic ulcer; 5. Severe renal or hepatic insufficiency; 6. Thrombo-embolism in history; 7. Hemorrhagic diathesis; 8. Idiopathic thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of preeclampsia before 34 weeks gestational age. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in spontaneous abortion, maternal admission to hospital and neonatal intensive care admission; 2. Increase in gestational age and weight at birth. | — |
Contacts
Public ContactJ.I.P. Vries, de
VU Medical Center, Department of Obstetrics and Gynaecology, P.O. Box 7057
Outcome results
None listed