Background Whether low-dose aspirin prevents preeclampsia is unclear.
It is not recommended as prophylaxis in women at low risk for preeclam
psia but may reduce the incidence of the disease in women at high risk
. Methods We conducted a double-blind, randomized, placebo-controlled
trial in four groups of pregnant women at high risk for preeclampsia,
including 471 women with pregestational insulin-treated diabetes melli
tus, 774 women with chronic hypertension, 688 women with multifetal ge
stations, and 606 women who had had preeclampsia during a previous pre
gnancy. The women were enrolled between gestational weeks 13 and 26 an
d received either 60 mg of aspirin or placebo daily. Results Outcome d
ata were obtained on all but 36 of the 2539 women who entered the stud
y. The incidence of preeclampsia was similar in the 1254 women in the
aspirin group and the 1249 women in the placebo group (aspirin, 18 per
cent; placebo, 20 percent; P=0.23). The incidences in the aspirin and
placebo groups for each of the four high-risk categories were also sim
ilar: for women with pregestational diabetes mellitus, the incidence w
as 18 percent in the aspirin group and 22 percent in the placebo group
(P=0.38); for women with chronic hypertension, 26 percent and 25 perc
ent (P=0.66); for those with multifetal gestations, 12 percent and 16
percent (P=0.10); and for those with preeclampsia during a previous pr
egnancy, 17 percent and 19 percent (P=0.47). In addition, the incidenc
es of perinatal death, preterm birth, and infants small for gestationa
l age were similar in the aspirin and placebo groups. Conclusions In o
ur study, low-dose aspirin did not reduce the incidence of preeclampsi
a significantly or improve perinatal outcomes in pregnant women at hig
h risk for preeclampsia. (C) 1998, Massachusetts Medical Society.