Anticoagulants for Living Fetuses in women with recurrent miscarriage and inherited thrombophilia; ALIFE2 study - ALIFE2

Academic Medical Center Amsterdam0 个研究点目标入组 399 人开始时间: 2018年9月5日最近更新: 2018年10月15日

试验速览

暂无简介。

•-Women with recurrent miscarriage and/or intra-uterine fetal deaths (= 2) irrespective of gestational age
•-Confirmed inherited thrombophilia; factor V Leiden mutation, prothrombin gene mutation (G20210A), protein S deficiency, protein C deficiency or antithrombin deficiency or a combination hereof. Protein S, -C and antithrombin deficiencies need to be confirmed by two independent tests, performed on two separate occasions and not during pregnancy or anticoagulant therapy.
•-Pregnancy confirmed by urine pregnancy test
•-Age 18 - 42 years at randomisation
•-Willing and able to give informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 399
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Duration of current pregnancy = 7 weeks , based on first day of last menstruation.
•-Indication for anticoagulant treatment during pregnancy (for instance prosthetic heart valves, a history of venous thromboembolism or antiphospholipid syndrome)
•-Contraindications to LMWH (previous heparin induced thrombocytopenia, active bleeds or renal insufficiency with creatinine clearance of less than 30ml/min)
•-Known allergy to at least 3 different LMWH preparations
•-Previous inclusion in the ALIFE2 study (for another pregnancy)

发起方

Academic Medical Center Amsterdam