|- candidate number||1539|
|- NTR Number||NTR337|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||11-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Low molecular weight heparin (FRagmin (R)) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia, a randomized trial (FRUIT-study).|
|- Scientific Title||Low molecular weight heparin (FRagmin (R)) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia, a randomized trial (FRUIT-study).|
|- hypothesis||Low molecular weight heparin plus aspirin reduces the recurrence of preeclampsia and/or small for gestational age infants before 34 weeks gestational age in women with documented thrombophilia with a history of preeclampsia and/or small for gestational age infants with birth before 34 weeks.|
|- Healt Condition(s) or Problem(s) studied||Pregnancy, Small for gestational age (SGA), Pre-eclampsia|
|- Inclusion criteria||1. Patients with a history of preeclampsia and/or small for gestaitonal age infants before 34 weeks gestation and documented thrombophilia restricted to proteine c and proteine S deficiency, APC resistance, Factor V Leiden mutation, FActor II mutation, anticardiolipin antibodies, lupus anticoagulant; |
2. Age > 18 years;
3. Informed consent.
|- Exclusion criteria||1. Antithrombine deficiency;|
2. Diabetes mullitus;
3. Known malignancy;
4. Gastro-duodenic ulcer;
5. Severe renal or hepatic insufficiency;
6. Thrombo-embolism in history;
7. Hemorrhagic diathesis;
8. Idiopathic thrombocytopenia.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||20-jan-2000|
|- planned closingdate||31-dec-2009|
|- Target number of participants||154|
|- Interventions||Two armed study: |
A: Daily dalteparin (starting between 6-12 weeks pregnancy) throughout gestation plus aspirin (starting before 12 weeks gestation to 36 weeks);
B: Aspirin only ( starting before 12 weeks to 36 weeks).
Both arms receive regular controls for women with a history of preeclampsia. In arm A: examination of Anti FActor Xa activity at 20 and 30 weeks.
|- Primary outcome||Reduction of preeclampsia before 34 weeks gestational age.|
|- Secondary outcome||1. Reduction in spontaneous abortion, maternal admission to hospital and neonatal intensive care admission;|
2. Increase in gestational age and weight at birth.
|- Trial web site||http://www.nvog.nl via members, studies, FRUIT-study|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. J.I.P. Vries, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.I.P. Vries, de|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Pharmacia & Upjohn Company|
|- Publications||This is the first trial with low molecular weight heparin in a population of women with a history of preeclampsia and will be submitted to an international journal.|
|- Brief summary||Uteroplacental insufficiency resulting in preeclampsia, eclampsia, HELLP syndrome (hemolysis, elevated liver enzymes and low platelets) fetal growth restriction and preterm birth is one of the major problems in perinatal medicine. |
The origin is multifactorioal and endothelial cell dysfunction is the final common pathway in the maternal syndrome preeclampsia. A substantial percentage of the women have thrombophilic disorders.
This multicenter open two-armed RCT will elucidate whether treatment with low molecular weight heparine during a following pregnancy is benificial for the maternal, fetal and neonatal morbidity and mortality.
|- Main changes (audit trail)|
|- RECORD||12-sep-2005 - 7-mrt-2006|