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Low molecular weight heparin (FRagmin (R)) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia, a randomized trial (FRUIT-study).


- candidate number1539
- NTR NumberNTR337
- ISRCTNISRCTN87325378
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR11-sep-2005
- Secondary IDsN/A 
- Public TitleLow molecular weight heparin (FRagmin (R)) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia, a randomized trial (FRUIT-study).
- Scientific TitleLow molecular weight heparin (FRagmin (R)) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia, a randomized trial (FRUIT-study).
- ACRONYMFRUIT-study
- hypothesisLow 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) studiedPregnancy, Small for gestational age (SGA), Pre-eclampsia
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 20-jan-2000
- planned closingdate31-dec-2009
- Target number of participants154
- InterventionsTwo 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 outcomeReduction of preeclampsia before 34 weeks gestational age.
- Secondary outcome1. Reduction in spontaneous abortion, maternal admission to hospital and neonatal intensive care admission;
2. Increase in gestational age and weight at birth.
- Timepoints
- Trial web sitehttp://www.nvog.nl via members, studies, FRUIT-study
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.I.P. Vries, de
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.I.P. Vries, de
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Pharmacia & Upjohn Company
- PublicationsThis 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 summaryUteroplacental 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)
- RECORD12-sep-2005 - 7-mrt-2006


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