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Low Molecular Weight Heparin and/or Aspirin in Prevention of Habitual Abortion (HABENOX)

This study has been completed.
Oulu University Hospital
Karolinska University Hospital
Leiden Hospital, Leiden, The Netherlands
Information provided by:
Helsinki University Identifier:
First received: July 21, 2009
Last updated: August 13, 2009
Last verified: August 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:

Study groups:

Group 1 : Enoxaparin 40 mg+ placebo, Group 2: Enoxaparin 40 +ASA 100 mg, Group 3: ASA.


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.

Condition Intervention Phase
Habitual Abortion Drug: Aspirin Drug: Klexane Drug: Klexane and ASA Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Bleeding complications, intrauterine growth retardation (<-2SD), pre-eclampsia, abruption placenta [ Time Frame: gestational weeks > 37 and gestational weeks >24, but <37 ]

Enrollment: 220
Study Start Date: January 2002
Study Completion Date: December 2008
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Aspirin
ASA 100 mg once daily per os
Active Comparator: Klexane
Clexane (enoxaparine) 40 mg sc
Drug: Klexane
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

  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • History of DVT or pulmonary embolism.
  • Significant bleeding history.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00959621

Helsinki University Hospital
Helsinki, Finland, 00290
Sponsors and Collaborators
Helsinki University
Oulu University Hospital
Karolinska University Hospital
Leiden Hospital, Leiden, The Netherlands
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
  More Information

Responsible Party: Professor Risto Kaaja, Helsinki University Hospital Identifier: NCT00959621     History of Changes
Other Study ID Numbers: HABENOX
Study First Received: July 21, 2009
Last Updated: August 13, 2009

Keywords provided by Helsinki University:
Habitual abortion
recurrent abortion
hereditary and acquired
premature birth
LMWH (low molecular weigh heparin)

Additional relevant MeSH terms:
Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
Heparin, Low-Molecular-Weight
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anticoagulants processed this record on September 21, 2017