Table 3.
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 thrombophiliaa | |
◦ 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) |
aProtein S, protein C and antithrombin deficiencies need to be confirmed by two tests, performed on two separate occasions and not during anticoagulant therapy. Protein S tests should not be performed during pregnancy or in the 6-week post-partum period since spuriously low levels may then be observed.