Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Role of LMWH (Enoxaparine) With or Without Aspirin in the Prevention of Habitual Abortion; Special Attention to the Thrombophilic Status of the Mother
Brief 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.


Options:
A: Arm Label: Standard of Care Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Low-molecular-weight heparin | Arm Label: Experimental Arm; Type: EXPERIMENTAL; Interventions: Drug: Aspirin 81 mg | Intervention Type: DRUG; Name: Aspirin 81 mg; Assigned to Arm(s): Experimental Arm | Intervention Type: DRUG; Name: Low-molecular-weight heparin; Assigned to Arm(s): Standard of Care Arm
B: Arm Label: ASA; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aspirin | Arm Label: Klexane; Type: ACTIVE_COMPARATOR; Interventions: Drug: Klexane | Arm Label: Aspirin and Enoxaparine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Klexane and ASA | Intervention Type: DRUG; Name: Aspirin; Assigned to Arm(s): ASA | Intervention Type: DRUG; Name: Klexane; Assigned to Arm(s): Klexane | Intervention Type: DRUG; Name: Klexane and ASA; Assigned to Arm(s): Aspirin and Enoxaparine
C: Arm Label: Group A(heparin group); Type: ACTIVE_COMPARATOR; Interventions: Drug: Heparin | Arm Label: Group B; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Heparin; Assigned to Arm(s): Group A(heparin group)
D: Arm Label: Rivaroxaban; Type: EXPERIMENTAL; Interventions: Drug: Experimental: Rivaroxaban | Arm Label: Warfarin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Experimental: Rivaroxaban | Intervention Type: DRUG; Name: Experimental: Rivaroxaban; Assigned to Arm(s): Rivaroxaban, Warfarin

Answer: B