Low Molecular Weight Heparin and/or Aspirin in Prevention of Habitual Abortion (HABENOX)
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:
Group 1 : Enoxaparin 40 mg+ placebo, Group 2: Enoxaparin 40 +ASA 100 mg, Group 3: ASA.
Group 1: Enoxaparin 40 twice daily+ placebo o.d., Group 2: Enoxaparin 40 mg twice daily +ASA 100 mg o.d.
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.
Drug: Klexane and ASA
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) [ Time Frame: gestational weeks >37 and gestational weeks > 24, but <37 ] [ Designated as safety issue: Yes ]
- Bleeding complications, intrauterine growth retardation (<-2SD), pre-eclampsia, abruption placenta [ Time Frame: gestational weeks > 37 and gestational weeks >24, but <37 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2002|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
Active Comparator: ASA
The patients received either Enoxaparine+placebo, Enoxaparine+ASA (Aspirin 100 mg) or ASA alone.ASA or placebo were blinded in the two first groups.
ASA 100 mg once daily per os
Active Comparator: Klexane
Clexane (enoxaparine) 40 mg sc
Klexane 40 mg sc once daily (HABENOX 1 and 2), Klexane 40 mg twice daily in HABENOX 3
|Active Comparator: Aspirin and Enoxaparine||
Drug: Klexane and ASA
Klexane 40 mgx 1 sc and ASA 100 mg po
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|Helsinki University Hospital|
|Helsinki, Finland, 00290|
|Principal Investigator:||Veli-Matti Ulander, MD||Helsinki University Hospital, Finland|
|Study Chair:||Laure Morin-Papunen, MD||Oulu University Hospital, Oulu, Finland|
|Study Chair:||Katja Lampinen, MD||Karolinska Hospital, Stockholm, Sweden|
|Study Chair:||Kitty Bloemenkamp, MD||Leiden University Hospital, Leiden, The Netherlands|
|Study Chair:||Janvier Visser, MD||Leiden University Hospital, Leiden, The Netherlands|