recurrent miscarriage inherited thrombophilia
Conditions
Interventions
Women in the intervention arm of the study will receive intermediate dose low molecular weight heparin once daily, started immediately after randomisation until delivery. Apart from this intervention
Sponsors
Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women with recurrent miscarriage (>= 2) irrespective of gestational age; 2. 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; 3. Pregnancy confirmed by urine pregnancy test; 4. Age 18 - 42 years at randomisation; 5. Willing and able to give informed consent.
Exclusion criteria
Exclusion criteria: 1. Duration of current pregnancy >= 7 weeks; 2. Indication for anticoagulant treatment during pregnancy (for instance prosthetic heart valves, a history of venous thromboembolism or antiphospholipid syndrome); 3. Contraindications to LMWH (previous heparin induced thrombocytopenia, active bleeds or renal insufficiency with creatinine clearance of less than 30ml/min); 4. Known allergy to at least 3 different LMWH preparations; 5. Previous inclusion in the ALIFE2 study (for another pregnancy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is life birth. Women in both study arms will be followed-up until delivery or until another (adverse) pregnancy outcome has occurred (e.g. miscarriage, termination of pregnancy, etc.). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of adversary pregnancy outcomes; 2. Pre-eclampsia; 3. HELLP syndrome; 4. Intrauterine growth restriction (IUGR); 5. Placental abruption; 6. Premature delivery; 7. Congenital malformations. Secondary outcomes for safety are: 1. Thrombocytopenia; 2. Hemorrhagic episodes (neonatal or maternal); 3. Allergic/skin reactions; redness or itching at injection site, anaphylaxis. | — |
Contacts
Public ContactP.G. Jong, de
Academisch Medisch Centrum, room F4-142 Meibergdreef 9
Outcome results
None listed