Status:
COMPLETED
Low Molecular Weight Heparin and/or Aspirin in Prevention of Habitual Abortion
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
Oulu University Hospital
Karolinska University Hospital
Conditions:
Habitual Abortion
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
1 % of all pregnancies end in habitual/recurrent abortion. In about half of women with habitual abortions (HAB) hereditary or acquired (antiphospholipid antibodies) thrombophilia are observed. The inv...
Detailed Description
Background: The prevalence of spontaneous abortions is 1000-1500/10000 pregnancies per year meaning that 10-15% of all pregnancies will end in an abortion; 1/10 of these abortions are recurrent (1 % o...
Eligibility Criteria
Inclusion
- Habenox 1: Three or more consecutive abortions of first trimester (ad h 12+6 wks) or two second trimester abortions (ad h 13 wks-23+6 wks) or one third trimester abortion (24 weeks or more) with one first-second trimester abortions and one thrombophiliatest positive: F V Leiden (heterozygote) or protein C or S deficiency, or anticardiolipin antibodies (low to moderate level), prothrombin gene mutation, or high level of F VIII.
- HABENOX 2: The thrombophilic tests above are negative.
- HABENOX 3:positive combined thrombophilia, F V Leiden (homozygote), anticardiolipin antibodies (high level \>40) , lupusanticoagulant, or AT III deficiency.
Exclusion
- History of DVT or pulmonary embolism.
- Significant bleeding history.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00959621
Start Date
January 1 2002
End Date
December 1 2008
Last Update
August 14 2009
Active Locations (1)
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1
Helsinki University Hospital
Helsinki, Finland, 00290