Objective: To examine whether combined treatment with low-molecular-weight heparin (LMWH) and aspirin reduces recurrent hypertensive disorders of pregnancy (HD: pre-eclampsia, eclampsia or HELLP syndrome) in women with antiphospholipid antibodies (aPLA) and a previous delivery for HD and/or small-for-gestational-age (SGA) birthweight before 34 weeks gestation.
Study design: This multicentre randomised controlled trial was performed between December 2000 and December 2009. Women were recruited from all eight university and six non-university/teaching hospitals in The Netherlands, two university hospitals in Australia and one university hospital in Sweden. Thirty two women with a previous delivery <34 weeks gestation with HD and/or SGA and aPLA were included before 12 weeks gestation. The intervention was daily LMWH with aspirin or aspirin alone.
Primary outcomes: recurrent HD onset <34 weeks and recurrent HD irrespective of gestational age. Analysis by intention-to-treat.
Results: After an interim analysis, recruitment was ceased: accrual was low and the incidence of recurrent HD was far lower (3%) than expected (60%). The final analysis, performed on 32 women, shows no difference in the primary outcomes (LMWH and aspirin 0/16 versus aspirin only 1/16, risk difference 6.25% [CI -17 to 27%] for recurrent HD onset <34 weeks and 0/16 for LMWH and aspirin versus 2/16 for aspirin only, risk difference 12.5% [CI -15 to 35%] for HD irrespective of gestational age).
Conclusion: In this population of women with aPLA, who had previously had an early delivery for HD and/or SGA prior to 34 weeks gestation, combined LMWH and aspirin treatment started before 12 weeks gestation in a subsequent pregnancy did not show reduction of onset of recurrent HD either <34 weeks gestation or irrespective of gestational age, compared with aspirin alone.
Keywords: Antiphospholipid antibodies; Aspirin; Low-molecular-weight heparin; Pre-eclampsia; Randomised controlled trial.
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