Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* history of two or more unexplained consecutive pregnancy losses prior to 32 weeks
* presence of one of the panel of autoantibodies/thrombophilia markers
* confirmed pregnancy

Exclusion Criteria:

* SLE
* known peptic ulcer disease
* sensitivity to ASA or heparin
* previous thrombotic event
* geographic distance from clinic
* failure to consent
B: Inclusion Criteria:

* 4 or more miscarriages before the end of gestational week 14 in patients with secondary recurrent miscarriages.
* At least three of these must be consecutive after the previous birth
* At least two of the miscarriages with the present partner.

Exclusion Criteria:

* Age below 18 or above 41 years at conception
* Significant uterine anomalies detected by hysterosalpingography, hysteroscopy or hydrosonography.
* Significant chromosomal aberrations in the couple
* Menstrual cycle \< 23 or \> 35 days
* Presence of lupus anticoagulant or IgG anticardiolipin concentration \>= 40 GPL ku/l or plasma homocystein \>= 25 microg./l by repeated measurements at 8 weeks intervals
* Tests positive for HIV or tests indicating carriage of hepatitis B or C
* IgA deficiency
* Allergy to albumin, IvIg or one of the substances added to preserve the drugs.
* Presence of chronic disease, which necessitate permanent treatment with e.g. corticosteroids , non-steroidal antiinflammatory drugs, anticoagulation, simvastatin or imurel from the start of pregnancy.
* Less than 2 of the previous pregnancy losses documented by ultrasound or uterine curettage.
* Present pregnancy a result of donor insemination or egg donation.
* Planned administration of gestagens or estrogens from the beginning of pregnancy.
* 3 or more previous IVF/ICSI/FER attempts resulting in chemical pregnancy/miscarriage.
* Previous participation in the trial.
C: 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.
D: Inclusion Criteria:

* Confirmed pregnancy;
* 18 years or older;
* Two or more unexplained pregnancy loss before the 10th week of gestation, AND/OR one or more unexplained pregnancy loss at or beyond the 10th week of gestation;
* One or more APS laboratory criteria present, according to the revised Sapporo criteria;

Exclusion Criteria:

* Greater than 11 weeks +6 days gestational age at time of randomization;
* Indication(s) for prophylactic or therapeutic-dose anticoagulation;
* Contraindication to heparin or aspirin;
* Received 7 or more doses of LMWH;
* Previous participation in the trial;
* Geographic inaccessibility;
* Refused consent.

Answer: C