Table 3 Inclusion and exclusion criteria

Inclusion criteria

• Women with recurrent miscarriage and/or intra-uterine fetal deaths (that is ≥ two miscarriages of intra-uterine fetal deaths, irrespective of gestational age)

• Confirmed inherited thrombophilia^a

 ◦ factor V Leiden mutation

 ◦ prothrombin gene mutation (G20210A)

 ◦ protein S deficiency

 ◦ protein C deficiency

 ◦ antithrombin deficiency

• Pregnancy confirmed by urine pregnancy test

• Age 18 to 42 years at randomization

• Willing and able to give informed consent

Exclusion criteria

• Duration of current pregnancy ≥ 7 weeks, based on first day of last menstruation

• Indication for anticoagulant treatment during pregnancy (e.g., prosthetic heart valves, a history of venous thromboembolism or antiphospholipid syndrome)

• Contraindications to LMWH (previous heparin-induced thrombocytopenia, active bleeding or renal insufficiency with creatinine clearance of < 30 ml/minute)

• Known allergy to at least three different LMWH preparations

• Previous inclusion in the ALIFE2 study (for another pregnancy)