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Antioxidant therapy to prevent preeclampsia: a randomized controlled trial.

Antioxidant therapy to prevent preeclampsia: a randomized controlled trial. Research Abstract Details 

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  • Antioxidant therapy to prevent preeclampsia: a randomized controlled trial. Abstract Text:

    joseph a spinnatoJoseph A Spinnato,salvio freireSalvio Freire,joao luiz pinto e silvaJoao Luiz Pinto E Silva,marilza vieira cunha rudgeMarilza Vieira Cunha Rudge, martins-costa Martins-Costa,matthew a kochMatthew A Koch,norman gocoNorman Goco,cleide de barros santosCleide de Barros Santos,jose guilherme cecattiJose Guilherme Cecatti,roberto costaRoberto Costa, ramos Ramos,nancy mossNancy Moss,baha m sibaiBaha M Sibai,joseph a spinnatoJoseph A Spinnato,salvio freireSalvio Freire,joao luiz pinto e silvaJoao Luiz Pinto E Silva,marilza vieira cunha rudgeMarilza Vieira Cunha Rudge, martins-costa Martins-Costa,matthew a kochMatthew A Koch,norman gocoNorman Goco,cleide de barros santosCleide de Barros Santos,jose guilherme cecattiJose Guilherme Cecatti,roberto costaRoberto Costa, ramos Ramos,nancy mossNancy Moss,baha m sibaiBaha M Sibai,

    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.

    Antioxidant therapy to prevent preeclampsia: a randomized controlled trial. Publishing Authors By Initials

    ja spinnatoJA Spinnato,s freireS Freire,jl pinto e silvaJL Pinto E Silva,mv cunha rudgeMV Cunha Rudge,s martins-costaS Martins-Costa,ma kochMA Koch,n gocoN Goco,cde santosCde Santos,jg cecattiJG Cecatti,r costaR Costa,jg ramosJG Ramos,n mossN Moss,bm sibaiBM Sibai,ja spinnatoJA Spinnato,s freireS Freire,jl pinto e silvaJL Pinto E Silva,mv cunha rudgeMV Cunha Rudge,s martins-costaS Martins-Costa,ma kochMA Koch,n gocoN Goco,cde santosCde Santos,jg cecattiJG Cecatti,r costaR Costa,jg ramosJG Ramos,n mossN Moss,bm sibaiBM Sibai,

    For similar abstracts research abstracts see: abstracts research

    PUBMED ID PMID:

    MEDLINE DATE:

    Antioxidant therapy to prevent preeclampsia: a randomized controlled trial. Journal Published:

    PUBLICATION TYPE: Research Support, N.I.H., Extr

    Journal: Obstetrics and gynecology

    VOLUME: 110

    Page Numbers: 1311-8

    Journal Abbreviation:

    ISSN: 0029-7844

    DAY: 6

    MONTH: Dec

    YEAR: 2007

    Antioxidant therapy to prevent preeclampsia: a randomized controlled trial. Information

    Number of References:

    LANGUAGE: eng

    NlmUniqueID: 401101

    Antioxidant therapy to prevent preeclampsia: a randomized controlled trial. Keywords Mesh Terms:

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    Chemical & Substance for Abstract: Antioxidant therapy to prevent preeclampsia: a randomized controlled trial. Information

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    Grant and Affiliation Information for Antioxidant therapy to prevent preeclampsia: a randomized controlled trial.

    AFFILIATION: Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, Ohio 40267-0526, USA. spinnaja@ucmail.uc.edu

    Country: United States

    United States Research PublicationUnited States Research Publication

    AGENCY: United States NICHD

    GRANT: 1 U01 HD40565

    ACRONYM: HD

    MEDLINETA: Obstet Gynecol

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