Anticoagulants for living fetuses for women with recurrent miscarriage and inherited blood clotting disorders.
Recruiting
- Conditions
- recurrent miscarriageinherited thrombophilia
- Registration Number
- NL-OMON27965
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 399
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;
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);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Prevalence of adversary pregnancy outcomes;<br /><br>2. Pre-eclampsia;<br /><br>3. HELLP syndrome;<br /><br>4. Intrauterine growth restriction (IUGR);<br /><br>5. Placental abruption;<br /><br>6. Premature delivery;<br /><br>7. Congenital malformations.<br><br /><br /><br>Secondary outcomes for safety are:<br /><br>1. Thrombocytopenia;<br /><br>2. Hemorrhagic episodes (neonatal or maternal);<br /><br>3. Allergic/skin reactions; redness or itching at injection site, anaphylaxis.