Document Detail

Low-Molecular-Weight Heparin Added to Aspirin in the Prevention of Recurrent Early-Onset Preeclampsia in women with Inheritable Thrombophilia: the FRUIT-RCT.
MedLine Citation:
PMID:  22118560     Owner:  NLM     Status:  Publisher    
Background: Early-onset hypertensive disorders of pregnancy (HD) and small-for-gestational age infants (SGA) are associated with placental vascular thrombosis, often recur and are also associated with inheritable thrombophilia. Aspirin reduces the recurrence risk. Objective: Adding low-molecular-weight heparin (LMWH) to aspirin at <12 weeks gestation reduces recurrence of HD in women with previous early-onset HD (preeclampsia, HELLP syndrome, eclampsia) and/or SGA, in the context of inheritable thrombophilia without antiphospholipid antibodies. Patients/Methods: In a multicenter RCT, 139 women were included <12 weeks gestation. Inclusion criteria: previous delivery <34 weeks gestation with HD and/or SGA; inheritable thrombophilia (protein C deficiency; protein S deficiency; activated protein C resistance; Factor V Leiden heterozygosity; prothrombin gene G20210A mutation heterozygosity); no antiphospholipid antibodies detected. Intervention: either daily LMWH (dalteparin, 5000 IU weight-adjusted dosage) with aspirin 80 mg or aspirin 80 mg alone. Main outcome measures: Primary outcomes: recurrent HD onset 1) <34 weeks gestation and 2) irrespective of gestational age. Secondary outcomes: recurrent SGA, preterm birth, maternal/neonatal hospitalization, spontaneous abortion, individual HD. Analysis by intention-to-treat. Results: LMWH with aspirin reduced recurrent HD onset <34 weeks gestation (risk difference (RD) 8.7%: CI of RD 1.9-15.5%; p=.012; NNT 12). Recurrent HD irrespective of gestational age was not different between arms. No women withdrew for adverse effects. Trial Registration: (isrctn87325378). Conclusions: Adding LMWH to aspirin at <12 weeks gestation reduces recurrent HD onset <34 weeks gestation in women with inheritable thrombophilia and prior delivery for HD/SGA <34 weeks. Close monitoring of mother and fetus remains important throughout pregnancy.
J I P de Vries; M G van Pampus; W M Hague; P D Bezemer; J H Joosten;
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-11-25
Journal Detail:
Title:  Journal of thrombosis and haemostasis : JTH     Volume:  -     ISSN:  1538-7836     ISO Abbreviation:  -     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-11-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101170508     Medline TA:  J Thromb Haemost     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 International Society on Thrombosis and Haemostasis.
Department of Obstetrics and Gynaecology, VU University Medical Center, Amsterdam Department of Obstetrics and Gynaecology, University Medical Center, Groningen, The Netherlands Department of Obstetrics and Gynaecology, University of Adelaide, Women's and Children's Hospital, Adelaide, Australia Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
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