Low-dose aspirin reduces the risk for preterm preeclampsia among women at high risk for the condition, a new study shows.
Daniel L. Rolnik, MD, from King’s College Hospital, London, England, and colleagues published the results of their randomized controlled trial online June 28 in the New England Journal of Medicine.
“[T]he administration of aspirin at a dose of 150 mg per day from 11 to 14 weeks of gestation until 36 weeks of gestation was associated with a significantly lower incidence of preterm preeclampsia than was placebo,” the authors write.
“The size of the treatment effect was consistent across estimated risk groups at the time of screening, across groups defined according to obstetrical history, and across countries of the participating centers.”
Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality. In addition, severe and early-onset preeclampsia substantially raise the risk for these complications. Developing strategies for early identification and treatment of women at high risk for preterm preeclampsia thus remains a priority.
Previous studies have shown that treatment with low-dose aspirin during pregnancy is beneficial for prevention of preeclampsia, and professional associations recommend use of low-dose aspirin during pregnancy in women at high risk for the condition. However, it is still unclear whether this treatment lowers the risk for preterm preeclampsia among high-risk women.
Screening strategies currently used to identify women at high risk for preterm preeclampsia also perform suboptimally, the authors write.
The researchers therefore aimed to investigate whether treatment with low-dose aspirin during pregnancy reduces the risk for preterm preeclampsia among women at high risk for the condition. To identify women at high risk for preterm preeclampsia, they used a screening algorithm that combines maternal demographic characteristics and historical factors and biomarkers. This approach has been shown to perform better than other currently used strategies, they say.
In their double-blind, placebo-controlled trial, the researchers analyzed data collected at 13 maternity hospitals in the United Kingdom, Spain, Italy, Belgium, Greece, and Israel.
The trial included 1620 women with singleton pregnancies who were identified as being at high risk for preterm preeclampsia by means of first-trimester screening in the participating hospitals. The researchers randomly assigned the women to receive aspirin (150 mg per day) or placebo, from 11 to 14 weeks of gestation until 36 weeks of gestation.
Low-dose treatment significantly lowered the risk for preterm preeclampsia. Preterm preeclampsia occurred in 13 women (1.6%) who received aspirin compared with 35 (4.3%) who received the placebo (odds ratio in the aspirin group, 0.38; 95% confidence interval, 0.20 – 0.74; P = .004).
The authors found no significant difference between the groups in the incidence of other pregnancy complications, neonatal adverse outcomes, or other adverse events. However, the trial was underpowered for these secondary outcomes, they say.
Dr Rolnik and colleagues also note that the 4.3% incidence of preterm preeclampsia in the placebo group was lower than the expected value of 7.6% (based on a model for prediction of preeclampsia).
“[T]his finding is likely to be the consequence of differences between the demographic characteristics of the screened population and those of the population that was used for the development of the algorithm,” they conclude.
This study was supported by grants from the European Union Seventh Framework Program and from the Fetal Medicine Foundation. The authors have disclosed no relevant financial relationships.
N Engl J Med. Published online June 28, 2017. Full text
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