Low Molecular Weight Heparin and/or Aspirin in Prevention of Habitual Abortion (HABENOX)
|ClinicalTrials.gov Identifier: NCT00959621|
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : August 14, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Habitual Abortion||Drug: Aspirin Drug: Klexane Drug: Klexane and ASA||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2008|
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
- 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 ]
- Bleeding complications, intrauterine growth retardation (<-2SD), pre-eclampsia, abruption placenta [ Time Frame: gestational weeks > 37 and gestational weeks >24, but <37 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959621
|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|
|Study Chair:||Katja Lampinen, MD||Karolinska University Hospital|
|Study Chair:||Kitty Bloemenkamp, MD||Leiden University Hospital, Leiden, The Netherlands|
|Study Chair:||Janvier Visser, MD||Leiden University Hospital, Leiden, The Netherlands|