Low molecular weight heparin increases live birth in women with recurrent miscarriage and inherited thrombophilia when compared to no treatment.
ID
Bron
Verkorte titel
Aandoening
recurrent miscarriage
inherited thrombophilia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.).
Achtergrond van het onderzoek
In 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.
Doel van het onderzoek
Low molecular weight heparin increases live birth in women with recurrent miscarriage and inherited thrombophilia when compared to no treatment.
Onderzoeksopzet
1. Outcome 1: Gestational age of 12 weeks;
2. Outcome 2: Gestational age of 24 weeks;
3. Outcome 3: Delivery and/or end of pregnancy.
Onderzoeksproduct en/of interventie
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 they will receive standard pregnancy surveillance.
Women in the second arm of the study will receive no intervention on top of standard pregnancy surveillance.
Algemeen / deelnemers
Meibergdreef 9
P.G. Jong, de
Amsterdam 1105 AZ
The Netherlands
p.g.dejong@amc.uva.nl
Wetenschappers
Meibergdreef 9
P.G. Jong, de
Amsterdam 1105 AZ
The Netherlands
p.g.dejong@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3210 |
| NTR-old | NTR3361 |
| Ander register | EudraCT : 2012-001447-43 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |