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Obstetrics & Gynecology 2007;110:1311-1318
© 2007 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Antioxidant Therapy to Prevent Preeclampsia

A Randomized Controlled Trial

Joseph A. Spinnato, II, MD1, Salvio Freire, MD2, Joao Luiz Pinto e Silva, MD3, Marilza Vieira Cunha Rudge, MD4, Sérgio Martins-Costa, MD5, Matthew A. Koch, MD6, Norman Goco6, Cleide de Barros Santos, MD2, Jose Guilherme Cecatti, MD3, Roberto Costa, MD4, José Geraldo Ramos, MD5, Nancy Moss, PhD7 and Baha M. Sibai, MD1

From the 1University of Cincinnati College of Medicine, Cincinnati, Ohio; 2Universidade Federal de Pernambuco, Hospital das Clínicas, Recife, Brazil; 3Universidade Estadual de Campinas, Campinas, Brazil; 4Universidade Estadual Paulista, Botucatu, Brazil; 5Universidade Federal Do Rio Grande Do Sul, Hospital de Clínicas, Porto Alegre, Brazil; 6RTI International, Research Triangle Park, North Carolina; and 7National Institute of Child Health and Human Development, Bethesda, Maryland.

OBJECTIVE: To study whether antioxidant supplementation will reduce the incidence of preeclampsia among patients at increased risk.

METHODS: A randomized, placebo-controlled, double-blind clinical trial was conducted at four Brazilian sites. Women between 12 0/7 weeks and 19 6/7 weeks of gestation and diagnosed to have chronic hypertension or a prior history of preeclampsia were randomly assigned to daily treatment with both vitamin C (1,000 mg) and vitamin E (400 International Units) or placebo. Analyses were adjusted for clinical site and risk group (prior preeclampsia, chronic hypertension, or both). A sample size of 734 would provide 80% power to detect a 40% reduction in the risk of preeclampsia, assuming a placebo group rate of 21% and {alpha}=.05. The {alpha} level for the final analysis, adjusted for interim looks, was 0.0458.

RESULTS: Outcome data for 707 of 739 randomly assigned patients revealed no significant reduction in the rate of preeclampsia (study drug, 13.8% [49 of 355] compared with placebo, 15.6% [55 of 352], adjusted risk ratio 0.87 [95.42% confidence interval 0.61–1.25]). There were no differences in mean gestational age at delivery or rates of perinatal mortality, abruptio placentae, preterm delivery, and small for gestational age or low birth weight infants. Among patients without chronic hypertension, there was a slightly higher rate of severe preeclampsia in the study group (study drug, 6.5% [11 of 170] compared with placebo, 2.4% [4 of 168], exact P=.11, odds ratio 2.78, 95% confidence interval 0.79–12.62).

CONCLUSION: This trial failed to demonstrate a benefit of antioxidant supplementation in reducing the rate of preeclampsia among patients with chronic hypertension and/or prior preeclampsia.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00097110

LEVEL OF EVIDENCE: I






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