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

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.

Conditions

• Habitual Abortion

Interventions

DRUG

Aspirin

ASA 100 mg once daily per os

DRUG

Klexane

Klexane 40 mg sc once daily (HABENOX 1 and 2), Klexane 40 mg twice daily in HABENOX 3

DRUG

Klexane and ASA

Klexane 40 mgx 1 sc and ASA 100 mg po

Sponsors & Collaborators

• Oulu University Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Leiden Hospital, Leiden, The Netherlands

  collaborator UNKNOWN

• University of Helsinki

  lead OTHER

Principal Investigators

• Veli-Matti Ulander, MD · Helsinki University Hospital, Finland

• Laure Morin-Papunen, MD · Oulu University Hospital

• Katja Lampinen, MD · Karolinska University Hospital

• Kitty Bloemenkamp, MD · Leiden University Hospital, Leiden, The Netherlands

• Janvier Visser, MD · Leiden University Hospital, Leiden, The Netherlands

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2002-01-31

Primary Completion

2004-12-31

Completion

2008-12-31

Countries

• Finland

Study Locations