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Anticoagulants for living fetuses for women with recurrent miscarriage and inherited blood clotting disorders.


- candidate number12089
- NTR NumberNTR3361
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-mrt-2012
- Secondary IDs2012-001447-43 EudraCT
- Public TitleAnticoagulants for living fetuses for women with recurrent miscarriage and inherited blood clotting disorders.
- Scientific TitleAnticoagulants for living fetuses for women with recurrent miscarriage and inherited thrombophilia.
- ACRONYMALIFE2 study
- hypothesisLow molecular weight heparin increases live birth in women with recurrent miscarriage and inherited thrombophilia when compared to no treatment.
- Healt Condition(s) or Problem(s) studiedRecurrent miscarriages, Inherited thrombophilia
- Inclusion criteria1. 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 criteria1. 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).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2012
- planned closingdate1-sep-2017
- Target number of participants399
- InterventionsWomen 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 they will receive standard pregnancy surveillance.
Women in the second arm of the study will receive no intervention on top of standard pregnancy surveillance.
- Primary outcomeThe 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 outcome1. 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.
- Timepoints1. Outcome 1: Gestational age of 12 weeks;
2. Outcome 2: Gestational age of 24 weeks;
3. Outcome 3: Delivery and/or end of pregnancy.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES P.G. Jong, de
- CONTACT for SCIENTIFIC QUERIESDr. S. Middeldorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryIn the ALIFE2 study women with recurrent miscarriage and inherited thrombophilia will be randomised to either low molecular weight heparin or standard pregnancy surveillance in a subsequent pregnancy. The study is designed to evaluate the effect of low molecular weight heparin on live birth in these women.
- Main changes (audit trail)
- RECORD19-mrt-2012 - 16-jan-2013


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