OBJECTIVE: To examine whether combined treatment with low-molecular-weight heparin (LMWH) and @entity117 reduces recurrent @entity101 of pregnancy ( @entity2033 : @entity1468 , @entity3036 or @entity2102 ) in women with antiphospholipid antibodies (aPLA) and a previous delivery for @entity2033 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. @entity1 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 @entity1 with a previous delivery <34 weeks gestation with @entity2033 and/or SGA and aPLA were included before 12 weeks gestation. The intervention was daily LMWH with @entity117 or @entity117 alone. Primary outcomes: recurrent @entity2033 onset <34 weeks and recurrent @entity2033 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 @entity2033 was far lower (3%) than expected (60%). The final analysis, performed on 32 @entity1 , shows no difference in the primary outcomes (LMWH and @entity117 0/16 versus @entity117 only 1/16, risk difference 6.25% [CI -17 to 27%] for recurrent @entity2033 onset <34 weeks and 0/16 for LMWH and @entity117 versus 2/16 for @entity117 only, risk difference 12.5% [CI -15 to 35%] for @entity2033 irrespective of gestational age). CONCLUSION: In this population of @entity1 with aPLA, who had previously had an early delivery for @entity2033 and/or SGA prior to 34 weeks gestation, combined LMWH and @entity117 treatment started before 12 weeks gestation in a subsequent pregnancy did not show reduction of onset of recurrent @entity2033 either <34 weeks gestation or irrespective of gestational age, compared with @entity117 alone.

Low-molecular-weight heparin and XXXX in the prevention of recurrent early-onset @entity1468 in women with antiphospholipid antibodies: the FRUIT-RCT.

@entity1 :: ('9606', 'Species') :: ['women', 'Women'] @entity101 :: ('MESH:D006973', 'Disease') :: ['hypertensive disorders'] @entity2102 :: ('MESH:D017359', 'Disease') :: ['HELLP syndrome'] @entity117 :: ('MESH:D001241', 'Chemical') :: ['aspirin'] @entity2033 :: ('MESH:D006816', 'Disease') :: ['HD'] @entity3036 :: ('MESH:D004461', 'Disease') :: ['eclampsia'] @entity1468 :: ('MESH:D011225', 'Disease') :: ['pre-eclampsia']
@entity117 :: (MESH:D001241,Chemical) :: ['aspirin']
