Anticoagulants for Living Fetuses in women with recurrent miscarriage and inherited thrombophilia; ALIFE2 study

Phase 3

Recruiting

Conditions: habitual abortion
recurrent miscarriage
10064477
10000211

Registration Number: NL-OMON43583

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

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

-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);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy outcome is live birth in each treatment group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy outcome measures are prevalence of adverse pregnancy<br /><br>outcomes, such as miscarriage rates, pre-eclampsia, the syndrome of haemolysis,<br /><br>elevated liver enzymes en low platelets (HELLP-syndrome), intrauterine growth<br /><br>restriction, placental abruption, premature delivery and congenital<br /><br>malformations.<br /><br>Safety outcomes are thrombocytopenia, hemorrhagic episodes and skin reactions<br /><br>to the prescribed study medication.</p><br>