Anticoagulants (blooding thinning medications) for pregnant women who have suffered 2 or more miscarriages and inherited thrombophilia (increased clotting tendency)

Anticoagulants for Living FoEtuses in women with recurrent miscarriage and inherited thrombophilia : ALIFE 2 - ALIFE 2

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002357-35-GB

Enrollment

400

Registered

2015-07-16

Start date

2015-09-22

Completion date

Unknown

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inherited thrombophilia in recurrent miscarriage

Interventions

Trade Name: Clexane Product Name: Enoxaparin Sodium Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Enoxaparin Sodium Other descriptive name: Clexane Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria (at Registration) • Provision of written informed consent • Women with recurrent miscarriage and/or intra-uterine foetal deaths (i.e. = 2 consecutive or non-consecutive miscarriages of intra-uterine foetal deaths, irrespective of gestational age) • Inherited thrombophilia; confirmed by factor V Leiden mutation, prothrombin gene mutation (G20210A), protein S deficiency, protein C deficiency or antithrombin deficiency or a combination hereof. (Protein 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). • Age 18 - 42 years* *participants that are registered at age 42 must also be aged 42 at the time pregnancy is confirmed and they are randomised onto the trial. Registered participants that turn 43 prior to becoming pregnant should be informed they will not be eligible to be randomised on to the ALIFE2 trial. Additional Inclusion Criteria (at randomisation) • Pregnancy confirmed by urine pregnancy test in hospital (=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Exclusion criteria (for registration) • Duration of current pregnancy = 7 weeks, based on first day of last menstruation or confirmed via ultrasound scan. • Weight = <50kg • 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, osteoporosis, hyperaldosteronism) • Known allergy to at least 3 different LMWH preparations • Previous inclusion in the ALIFE2 study (for another pregnancy) • Participation in a clinical trial of an investigational medicinal product in the last 90 days.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of low molecular weight heparin (LMWH) in women with inherited thrombophilia who have experienced 2 or more recurrent miscarriages and/or intra-uterine foetal death. ;Secondary Objective: To evaluate other possible effects of LMWH on adverse pregnancy outcome other than miscarriage (e.g. preeclampsia, intra-uterine growth restriction, HELLP syndrome, placental abruption, premature delivery, congenital malformations) To evaluate the safety of LMWH in women with recurrent miscarriage with inherited thrombophilia by registering complications such as bleeding, thrombocytopenia and (allergic) skin reactions. ;Primary end point(s): Live birth (defined as birth of a living child);Timepoint(s) of evaluation of this end point: End of pregnancy	—

Measure

Time frame

Main Objective: To evaluate the efficacy of low molecular weight heparin (LMWH) in women with inherited thrombophilia who have experienced 2 or more recurrent miscarriages and/or intra-uterine foetal death. ;Secondary Objective: To evaluate other possible effects of LMWH on adverse pregnancy outcome other than miscarriage (e.g. preeclampsia, intra-uterine growth restriction, HELLP syndrome, placental abruption, premature delivery, congenital malformations) To evaluate the safety of LMWH in women with recurrent miscarriage with inherited thrombophilia by registering complications such as bleeding, thrombocytopenia and (allergic) skin reactions. ;Primary end point(s): Live birth (defined as birth of a living child);Timepoint(s) of evaluation of this end point: End of pregnancy

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy: To evaluate other possible effects of LMWH on adverse pregnancy outcome other than miscarriage (e.g. preeclampsia, intra-uterine growth restriction, HELLP syndrome, placental abruption, premature delivery, congenital malformations) Safety: To evaluate the safety of LMWH in women with RM with inherited thrombophilia by registering complications such as bleeding, thrombocytopenia and (allergic) skin reactions. ;Timepoint(s) of evaluation of this end point: 12 weeks gestation, 24 weeks gestation, 36 weeks gestation, 6 week post live birth/end of pregnancy	—

Measure

Time frame

Secondary end point(s): Efficacy: To evaluate other possible effects of LMWH on adverse pregnancy outcome other than miscarriage (e.g. preeclampsia, intra-uterine growth restriction, HELLP syndrome, placental abruption, premature delivery, congenital malformations) Safety: To evaluate the safety of LMWH in women with RM with inherited thrombophilia by registering complications such as bleeding, thrombocytopenia and (allergic) skin reactions. ;Timepoint(s) of evaluation of this end point: 12 weeks gestation, 24 weeks gestation, 36 weeks gestation, 6 week post live birth/end of pregnancy

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Countries

Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Lithuania, Netherlands, New Zealand, United Kingdom, United States

Contacts

Public ContactWarwick Clinical Trials Unit

University of Warwick

ALIFE2@warwick.ac.uk024 7615 0478

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026