ASPRE
Trial question
What is the effect of aspirin in patients with singleton pregnancies at high risk for preterm preeclampsia?
Study design
Multi-center
Double blinded
RCT
Population
1776 female patients
Inclusion criteria: female patients with singleton pregnancies at high risk for preterm preeclampsia
Key exclusion criteria: unconscious or severely ill status, learning difficulties or serious mental illness, major fetal abnormality identified at the time that scanning was performed at 11-13 weeks of gestation, von Willebrand's disease, peptic ulceration, hypersensitivity to aspirin, long-term use of nonsteroidal antiinflammatory medication
Interventions
N=798 aspirin (150 mg/day from 11-14 weeks gestation until 36 weeks of gestation)
N=822 placebo (matching placebo from 11-14 weeks of gestation until 36 weeks of gestation)
Primary outcome
Preterm preeclampsia
1.6
4.3
4.3 %
3.2 %
2.1 %
1.1 %
0.0 %
Aspirin
Placebo
Significant decrease ▼
NNT = 37
Significant decrease in preterm preeclampsia (1.6% vs. 4.3%; OR 0.38, 95% CI 0.2 to 0.74)
Secondary outcomes
No significant difference in stillbirth or death (1% vs. 1.7%; OR 0.59, 99% CI 0.19 to 1.85)
Safety outcomes
No significant difference in neonatal or other adverse events.
Conclusion
In female patients with singleton pregnancies at high risk for preterm preeclampsia, aspirin was superior to placebo with respect to preterm preeclampsia.
Reference
Rolnik DL, Wright D, Poon LC et al. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622.
Open reference URL