Document Detail


Antioxidant therapy to prevent preeclampsia: a randomized controlled trial.
MedLine Citation:
PMID:  18055726     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Joseph A Spinnato; Salvio Freire; Joao Luiz Pinto E Silva; Marilza Vieira Cunha Rudge; Sérgio Martins-Costa; Matthew A Koch; Norman Goco; Cleide de Barros Santos; Jose Guilherme Cecatti; Roberto Costa; José Geraldo Ramos; Nancy Moss; Baha M Sibai
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  110     ISSN:  0029-7844     ISO Abbreviation:  Obstet Gynecol     Publication Date:  2007 Dec 
Date Detail:
Created Date:  2007-12-06     Completed Date:  2008-01-17     Revised Date:  2009-10-26    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1311-8     Citation Subset:  AIM; IM    
Affiliation:
Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, Ohio 40267-0526, USA. spinnaja@ucmail.uc.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00097110
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MeSH Terms
Descriptor/Qualifier:
Adult
Antioxidants / therapeutic use*
Ascorbic Acid / therapeutic use*
Double-Blind Method
Female
Humans
Hypertension / drug therapy*
Pre-Eclampsia / prevention & control*
Pregnancy
Pregnancy Outcome
Vitamin E / therapeutic use*
Grant Support
ID/Acronym/Agency:
1 U01 HD40565/HD/NICHD NIH HHS
Chemical
Reg. No./Substance:
0/Antioxidants; 1406-18-4/Vitamin E; 50-81-7/Ascorbic Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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