Kenneth L. Smith, Mercer College of Pharmacy
Preeclampsia is a disorder that can lead to hypertension in pregnancy and is often accompanied with a significant amount of protein excreted in the urine.  It has been considered to be an important cause of both maternal and prenatal death  and affects approximately 5–8% of all pregnancies worldwide . Placental anti-angiogenic factors may play a central role in the vascular dysfunction that leads to this disorder. [4 The American College of Obstetricians and Gynecologist recommends the use of aspirin in women with a history of preeclampsia in either more than one pregnancy or those that resulted in a delivery prior to 34 weeks gestation. This study explored the reduction in incidence of preeclampsia, in high risk pregnancies, starting from 11 to 14 weeks and continuing through the 36th week of gestation. 
|Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia |
|Design||Multicenter, double-blind, placebo-controlled trial; N = 1,620|
|Objective||To compare the incidence of preeclampsia from 11-14 weeks until 36 weeks of gestation after treatment with either 150 mg/day aspirin or placebo|
|Study Groups||Aspirin (n = 798); placebo (n = 822)|
|Methods||Women with singleton pregnancies that were at high risk for preterm preeclampsia received 150 mg aspirin per day, or placebo starting from 11 to 14 weeks of gestation and continuing until 36 weeks gestation. The incidence of preeclampsia before 37 weeks of gestation was analyzed based on the intention to treat principle. Participants had to be > 18 years of age. The risk of preeclampsia was assessed by an algorithm that combined maternal factors, mean arterial pressure, uterine-artery pulsatility, etc|
|Primary Outcome Measure||Delivery with preeclampsia before 37 weeks of gestation.|
|Adverse Events||Common adverse events: N/A|
|Serious adverse events: ≥ 37 weeks: Preeclampsia (6.6% aspirin and 7.2% placebo), gestational hypertension (9.0% aspirin and 7.5% placebo), stillbirth without preeclampsia (0.3% aspirin and 0.2% placebo), spontaneous delivery < 37 weeks: 5.0% aspirin and 6.0% placebo, miscarriage or stillbirth < 37 weeks: 1.8% aspirin and 2.3% placebo.|
|Percentage that discontinued due to adverse events: Maternal death due to embolism: 0% in aspirin group and 0.1% placebo|
|Study Author Conclusions||Women with singleton pregnancies that were high risk for preterm preeclampsia had a lower incidence when administered aspirin 150 mg per day, compared to placebo.|
Treatment with 150 mg aspirin per day resulted in a significantly lower incidence of preeclampsia when compared with placebo.  It also appears to be an important contribution in protecting pregnant women and their babies against the dangers of preeclampsia.
Compliance was measured by reporting the tablet counts during telephone interviews which may have led to bias by the possibility of patients relying on memory or either over- or underestimating how many tablets were actually used. Also, the study was powered for the primary outcome and not for incidence of pregnancy complications, adverse fetal or neonatal outcomes. Therefore, further studies may be useful to determine statistical differences in the incidence of adverse events between the two groups.
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 Rolnik DL, Wright D, Poon LC, et al. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017;377(7):613-622.