Anticoagulants (blooding thinning medications) for pregnant women who have suffered 2 or more miscarriages and inherited thrombophilia (increased clotting tendency)
- Conditions
- Inherited thrombophilia in recurrent miscarriageTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2015-002357-35-GB
- Lead Sponsor
- Research, Development & Innovation Department, UHCW NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 400
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 (<7 weeks gestation – based on first day of last menstruation or confirmed via ultrasound scan).
• Age 18 - 42 years
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br><br>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. <br>;Primary end point(s): Live birth (defined as birth of a living child);Timepoint(s) of evaluation of this end point: End of pregnancy
- Secondary Outcome Measures
Name Time Method 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)<br>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. <br>;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