Low-dose aspirin treatment in women at high risk for preterm preeclampsia resulted in a lower incidence of this diagnosis compared with the rate in high-risk women who received a placebo, according to a study published in the New England Journal of Medicine.
Daniel L. Rolnik, MD, from King’s College Hospital in London, and colleagues conducted a multicenter, double-blind, placebo-controlled trial to compare aspirin at a dose of 150 mg per day with placebo that was administered from 11 to 14 weeks of gestation until 36 weeks of gestation in women with singleton pregnancies who were at high risk for preterm preeclampsia. Women were included if they were 18 years or older, had a singleton pregnancy with a live fetus at the time of scanning, and a high risk (>1 in 100) for preterm preeclampsia.
The primary outcome measure was delivery with preeclampsia before 37 weeks of gestation. Secondary outcomes were adverse outcomes of pregnancy before 34 weeks of gestation, before 37 weeks of gestation, and at or after 37 weeks of gestation; stillbirth or neonatal death; death and neonatal complications; neonatal therapy; and low birth weight.
A total of 798 participants were included in the aspirin group and 822 in the placebo group. Preterm preeclampsia occurred in 13 women (1.6%) in the aspirin group, compared with 35 (4.3%) in the placebo group (odds ratio [OR] in the aspirin group, 0.38).
In the aspirin group, at least one serious adverse event occurred in 13 participants (1.6%), and at least one adverse event occurred in 207 women (25.9%); in the placebo group, at least one serious adverse event occurred in 26 participants (3.2%), and at least one adverse event occurred in 210 women (25.5%). No significant between-group difference in the incidence of these events was observed.
“This randomized trial showed that among women with singleton pregnancies who were identified by means of first-trimester screening as being at high risk for preterm preeclampsia, the administration of aspirin at a dose of 150 mg per day from 11 to 14 weeks of gestation until 36 weeks of gestation resulted in a significantly lower incidence of preterm preeclampsia than that with placebo,” the authors concluded.
- Rolnik DL, Wright D, Poon LC, et al. Aspirin versus placebo in pregnancies at high risk for preterm preeclampsia. N Engl J Med. 28 June 2017. doi: 10.1056/NEJMoa1704559