Randomised controlled trial of aspirin and aspirin plus heparin in pregnant women with recurrent miscarriage associated with phospholipid antibodies (or antiphospholipid antibodies)

Abstract

Treatment with aspirin and heparin leads to a significantly higher rate of live births in women with a history of recurrent miscarriage associated with phospholipid antibodies than that achieved with aspirin alone.

Management of the obstetric antiphospholipid syndrome

“…The fact that many important studies on the treatment of obstetric APS (27)(28)(29)(30)(31)(32) evoked letters to the editor (33-39) disputing their reported cutoffs in the aCL ELISA illustrates that consensus is urgently needed.…”

“…In those women whose pregnancy and clinical histories put them in the second category (those with recurrent early fetal loss or at least 1 fetal loss, without SLE or previous thrombosis), 3 observational studies evaluated the outcome in women treated with aspirin alone (44), those who received a combination of heparin and aspirin (45), and those who declined pharmacologic treatment and received standard care (46). In 9 prospective studies (12,(29)(30)(31)(32)(47)(48)(49)(50), 2 treatment strategies were compared. All but 2 of these studies (47,50) were randomized studies.…”

“…All but 2 of these studies (47,50) were randomized studies. The treatments included placebo (12,29,32), aspirin alone (12,(30)(31)(32)47,49), aspirin plus prednisone (29,48,49), and heparin plus aspirin (30,31,47,48,50) (Table 3). Evaluation of pregnancies started with a positive pregnancy test (12,29,32,44,47,48,50) or the presence of fetal heart activity (30,31,45,46,49).…”

“…Most women in these studies met the criteria for obstetric APS (14), because they had at least 3 consecutive miscarriages (12,(30)(31)(32)(45)(46)(47)50), at least 2 unexplained pregnancy losses before 12 weeks of gestation or at least 1 pregnancy loss after 12 weeks (44,48,49), or at (47,50). Three studies (47,48,50) emphasized exclusion of women with low aCL levels, and another (49) emphasized inclusion of women with low aCL levels.…”

“…Two studies (47,50) excluded women with LAC, and another did not test for LAC (12). In studies that tested women for both LAC and aCL, the prevalence of LAC varied from 6% (49) to 91% (30), whereas the frequency of LAC in the absence of aCL was 6% (49), 22% (32,44), 47% (31), 55% (45), and 82% (30). We will review these studies in relation to treatment (Table 3).…”