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Low-molecular-weight heparin added to aspirin in the prevention of recurrent early-onset pre-eclampsia in women with inheritable thrombophilia: the FRUIT-RCT

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dc.contributor.authorde Vries, J.
dc.contributor.authorvan Pampus, M.
dc.contributor.authorHague, W.
dc.contributor.authorBezemer, P.
dc.contributor.authorJoosten, J.
dc.date.issued2012
dc.description.abstractBackground: Early-onset hypertensive disorders (HD) of pregnancy and small-for-gestational age infants (SGA) are associated with placental vascular thrombosis, these often recur and are also associated with inheritable thrombophilia. Aspirin reduces the recurrence risk. Objectives: Adding low-molecular-weight heparin (LMWH) to aspirin at < 12 weeks gestation reduces the recurrence of HD in women with previous early-onset HD (pre-eclampsia, hemolysis, elevated liver enzymes and low platelets [HELLP] syndrome and eclampsia) and/or SGA, in the context of inheritable thrombophilia without antiphospholipid antibodies. Patients/methods: In a multicenter randomized control trial (RCT), 139 women included were < 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 and prothrombin gene G20210A mutation heterozygosity); and 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 (i) < 34 weeks gestation and (ii) irrespective of gestational age. Secondary outcomes: recurrent SGA, preterm birth, maternal/neonatal hospitalization, spontaneous abortion and individual HD. Analysis by intention-to-treat. Results:  Low-molecular-weight heparin with aspirin reduced recurrent HD onset < 34 weeks gestation (risk difference [RD] 8.7%: confidence interval [CI] of RD 1.9–15.5%; P = 0.012; number needed to treat [NNT] 12). Recurrent HD irrespective of gestational age was not different between the arms. No women withdrew as a result of adverse effects. Trial Registration: http://www.isrctn.org) (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. However, close monitoring of the mother and fetus remains important throughout pregnancy.
dc.description.statementofresponsibilityJ. I. P. De Vries, M. G. Van Pampus, W. M. Hague, P. D. Bezemer, J. H. Joosten and on behalf of Fruit Investigators
dc.identifier.citationJournal of Thrombosis and Haemostasis, 2012; 10(1):64-72
dc.identifier.doi10.1111/j.1538-7836.2011.04553.x
dc.identifier.issn1538-7933
dc.identifier.issn1538-7836
dc.identifier.orcidHague, W. [0000-0002-5355-2955]
dc.identifier.urihttp://hdl.handle.net/2440/69901
dc.language.isoen
dc.publisherBlackwell Publishers Ltd
dc.rights© 2011 International Society on Thrombosis and Haemostasis
dc.source.urihttps://doi.org/10.1111/j.1538-7836.2011.04553.x
dc.subjectaspirin
dc.subjectlow-molecular-weight heparin
dc.subjectpre-eclampsia
dc.subjectrandomized controlled trial
dc.subjectthrombophilia.
dc.titleLow-molecular-weight heparin added to aspirin in the prevention of recurrent early-onset pre-eclampsia in women with inheritable thrombophilia: the FRUIT-RCT
dc.typeJournal article
pubs.publication-statusPublished

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