habitual abortion recurrent miscarriage
Conditions
Interventions
The subjects will be randomly assigned to receive LMWH plus standard pregnancy
surveillance or standard pregnancy surveillance alone.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Women with recurrent miscarriage (>= 2) and/or intra-uterine fetal deaths (i.e. >= 2 miscarriages of intra-uterine fetal deaths, 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;
Exclusion criteria
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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome is live birth in each treatment group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy outcome measures are prevalence of adverse pregnancy outcomes, such as miscarriage rates, pre-eclampsia, the syndrome of haemolysis, elevated liver enzymes en low platelets (HELLP-syndrome), intrauterine growth restriction, placental abruption, premature delivery and congenital malformations. Safety outcomes are thrombocytopenia, hemorrhagic episodes and skin reactions to the prescribed study medication. | — |
Countries
Netherlands
Outcome results
None listed