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Original Article
Volume 338:701-705 March 12, 1998 Number 11
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Low-Dose Aspirin to Prevent Preeclampsia in Women at High Risk
Steve Caritis, M.D., Baha Sibai, M.D., John Hauth, M.D., Marshall D. Lindheimer, M.D., Mark Klebanoff, M.D., Elizabeth Thom, Ph.D., Peter VanDorsten, M.D., Mark Landon, M.D., Richard Paul, M.D., Menachem Miodovnik, M.D., Paul Meis, M.D., Gary Thurnau, M.D., Sidney Bottoms, Donald McNellis, James M. Roberts, for The National Institute of Child Health Human Development Network of Maternal–Fetal Medicine Units

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ABSTRACT

Background Whether low-dose aspirin prevents preeclampsia is unclear. It is not recommended as prophylaxis in women at low risk for preeclampsia 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 mellitus, 774 women with chronic hypertension, 688 women with multifetal gestations, and 606 women who had had preeclampsia during a previous pregnancy. The women were enrolled between gestational weeks 13 and 26 and received either 60 mg of aspirin or placebo daily.

Results Outcome data were obtained on all but 36 of the 2539 women who entered the study. The incidence of preeclampsia was similar in the 1254 women in the aspirin group and the 1249 women in the placebo group (aspirin, 18 percent; placebo, 20 percent; P = 0.23). The incidences in the aspirin and placebo groups for each of the four high-risk categories were also similar: for women with pregestational diabetes mellitus, the incidence was 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 percent (P = 0.66); for those with multifetal gestations, 12 percent and 16 percent (P = 0.10); and for those with preeclampsia during a previous pregnancy, 17 percent and 19 percent (P = 0.47). In addition, the incidences of perinatal death, preterm birth, and infants small for gestational age were similar in the aspirin and placebo groups.

Conclusions In our study, low-dose aspirin did not reduce the incidence of preeclampsia significantly or improve perinatal outcomes in pregnant women at high risk for preeclampsia.


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From the Departments of Obstetrics and Gynecology at the University of Pittsburgh, Pittsburgh (S.C.); University of Tennessee, Memphis (B.S.); University of Alabama, Birmingham (J.H.); University of Chicago, Chicago (M.D.L.); Medical University of South Carolina, Charleston (P.V.); Ohio State University, Columbus (M.L.); University of Southern California, Los Angeles (R.P.); University of Cincinnati, Cincinnati (M.M.); Bowman Gray School of Medicine, Winston-Salem, N.C. (P.M.); and University of Oklahoma, Oklahoma City (G.T.); the National Institute of Child Health and Human Development, Bethesda, Md. (M.K.); and the George Washington University Biostatistics Center, Washington, D.C. (E.T.). Other authors were Sidney Bottoms, M.D. (Wayne State University; deceased), Donald McNellis, M.D. (National Institute of Child Health and Human Development), and James M. Roberts, M.D. (University of Pittsburgh).

Address reprint requests to Dr. Caritis at the Department of Obstetrics, Gynecology and Reproductive Sciences, Magee–Women's Hospital, 300 Halket St., Rm. 2229, Pittsburgh, PA 15213.

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