Document Detail


Low-molecular-weight heparin added to aspirin in the prevention of recurrent early-onset pre-eclampsia in women with inheritable thrombophilia: the FRUIT-RCT.
MedLine Citation:
PMID:  22118560     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: 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.
Authors:
Johanna I P de Vries; M G van Pampus; W M Hague; P D Bezemer; J H Joosten;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of thrombosis and haemostasis : JTH     Volume:  10     ISSN:  1538-7836     ISO Abbreviation:  J. Thromb. Haemost.     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2012-04-02     Completed Date:  2012-12-20     Revised Date:  2014-07-31    
Medline Journal Info:
Nlm Unique ID:  101170508     Medline TA:  J Thromb Haemost     Country:  England    
Other Details:
Languages:  eng     Pagination:  64-72     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN87325378
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MeSH Terms
Descriptor/Qualifier:
Aspirin / administration & dosage*
Drug Therapy, Combination
Female
Gestational Age
Heparin, Low-Molecular-Weight / administration & dosage*
Humans
Pre-Eclampsia / drug therapy,  prevention & control*
Pregnancy
Recurrence / prevention & control
Thrombophilia / complications,  drug therapy*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Heparin, Low-Molecular-Weight; R16CO5Y76E/Aspirin
Investigator
Investigator/Affiliation:
J I de Vries / ; M G van Pampus / ; W M Hague / ; P D Bezemer / ; J H Joosten / ; J H Bruinse / ; J van Eyck / ; J M Middeldorp / ; J T Brons / ; W Visser / ; G A Dekker / ; H Wolf / ; M E Spaanderman / ; C J de Groot / ; S G Oei / ; D A Smit / ; K Bremme /
Comments/Corrections
Comment In:
J Thromb Haemost. 2012 Jun;10(6):1195; author reply 1196   [PMID:  22452781 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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