Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Role of LMWH (Enoxaparine) With or Without Aspirin in the Prevention of Habitual Abortion; Special Attention to the Thrombophilic Status of the Mother
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 investigators wanted to test whether antithrombotic treatment (Low-Molecular Weight Heparin, LMWH, ASA or both combined)would prevent these women from a subsequent abortion. Depending on thrombophilic status the women included in one of the three sub-studies: HABENOX 1 (mild, single thrombophilia), HABENOX 2 (no known thrombophilia), HABENOX 3 (moderate to severe thrombophilia, with combined thrombophilia or moderate to high titer antiphospholipid antibodies).
Study design: Randomised placebo controlled multicenter study.
Number of patients per study: 90 patients per group, 270 altogether.
Timetable: Starting 2/2002, finishing 31.12.2007.
Time frame: >37 weeks of gestation and >24, but <37 weeks of gestation (premature)
Treatment started before 7. gw.
HABENOX 1 and 2:
Study groups:
Group 1 : Enoxaparin 40 mg+ placebo, Group 2: Enoxaparin 40 +ASA 100 mg, Group 3: ASA.
HABENOX 3:
Study groups:
Group 1: Enoxaparin 40 twice daily+ placebo o.d., Group 2: Enoxaparin 40 mg twice daily +ASA 100 mg o.d.
Primary end-points:
Pregnancy outcome: livebirths ( ≥37 weeks of gestation), prema