Anticoagulants for living fetuses for women with recurrent miscarriage and inherited blood clotting disorders; ALIFE2 study

Phase 1

• Conditions: recurrent miscarriage and inherited thrombophilia; MedDRA version: 20.1Level: LLTClassification code 10027650Term: Miscarriage of pregnancySystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2012-001447-43-AT
• Lead Sponsor: Academic Medical Center Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-05
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 399

Inclusion Criteria

-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

Exclusion Criteria

-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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified