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Table 3 Inclusion and exclusion criteria

From: ALIFE2 study: low-molecular-weight heparin for women with recurrent miscarriage and inherited thrombophilia - study protocol for a randomized controlled trial

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)
  1. 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.