Low Molecular Weight Heparin and/or Aspirin in Prevention of Habitual Abortion
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
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), premature livebirths (≥24, but <37
weeks of gestation)
Secondary end-points: Bleeding complications, intrauterine growth retardation (<-2SD),
pre-eclampsia, abruptio placentae,
Ending: In the group of combined medication, tablets will be stopped at 36 weeks of
gesta-tion. LMWH will be started in all patients after delivery and continued 6 weeks
postpartum.
Phase:
Phase 3
Details
Lead Sponsor:
Helsinki University University of Helsinki
Collaborators:
Karolinska University Hospital Leiden Hospital, Leiden, The Netherlands Oulu University Hospital