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J Thromb Haemost. 2012 Jan;10(1):64-72. doi: 10.1111/j.1538-7836.2011.04553.x.

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

Author information

  • 1Department of Obstetrics and Gynaecology, VU University Medical Center, Amsterdam, the Netherlands. jip.devries@vumc.nl

Erratum in

  • J Thromb Haemost. 2015 Feb;13(2):327.

Abstract

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.

PMID:
22118560
[PubMed - indexed for MEDLINE]
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