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Randomized Controlled Trial
. 2008 Oct;199(4):433.e1-8.
doi: 10.1016/j.ajog.2008.07.011.

Antioxidant supplementation and premature rupture of the membranes: a planned secondary analysis

Joseph A Spinnato 2nd  1 , 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
Affiliations
Randomized Controlled Trial

Antioxidant supplementation and premature rupture of the membranes: a planned secondary analysis

Joseph A Spinnato 2nd et al. Am J Obstet Gynecol. 2008 Oct.

Abstract

Objective: The purpose of this study was to determine if antioxidant supplementation during pregnancy reduces the incidence of premature rupture of the membranes (PROM).

Study design: A placebo-controlled, double-blind trial was conducted. PROM and preterm PROM (PPROM) were planned secondary outcomes of the trial. Women between 12(0/7) and 19(6/7) weeks of gestation and diagnosed to have chronic hypertension or a prior history of preeclampsia were randomized to daily treatment with both vitamin C (1000 mg) and E (400 IU) or placebo.

Results: Outcome data for PROM were available for 697 of 739 patients. The rates of PROM (37/349 [10.6%] vs 19/348 [5.5%]; adjusted risk ratio [RR] 1.89 [95.42% CI, 1.11-3.23]; P = .015), and PPROM (16/349 [4.6%] vs 6/348 [1.7%]; RR 2.68 [1.07-6.71]; P = .025) were increased in the antioxidant group.

Conclusion: Contrary to expectations, vitamins C and E supplementation in this dose combination may be associated with an increased risk of PROM and PPROM.

Trial registration: ClinicalTrials.gov NCT00097110.

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References

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