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Randomized Controlled Trial
. 2010 Apr 8;362(14):1282-91.
doi: 10.1056/NEJMoa0908056.

Vitamins C and E to prevent complications of pregnancy-associated hypertension

James M Roberts  1 , Leslie Myatt, Catherine Y Spong, Elizabeth A Thom, John C Hauth, Kenneth J Leveno, Gail D Pearson, Ronald J Wapner, Michael W Varner, John M Thorp Jr, Brian M Mercer, Alan M Peaceman, Susan M Ramin, Marshall W Carpenter, Philip Samuels, Anthony Sciscione, Margaret Harper, Wendy J Smith, George Saade, Yoram Sorokin, Garland B Anderson; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network
Collaborators, Affiliations
Randomized Controlled Trial

Vitamins C and E to prevent complications of pregnancy-associated hypertension

James M Roberts et al. N Engl J Med. .

Abstract

Background: Oxidative stress has been proposed as a mechanism linking the poor placental perfusion characteristic of preeclampsia with the clinical manifestations of the disorder. We assessed the effects of antioxidant supplementation with vitamins C and E, initiated early in pregnancy, on the risk of serious adverse maternal, fetal, and neonatal outcomes related to pregnancy-associated hypertension.

Methods: We conducted a multicenter, randomized, double-blind trial involving nulliparous women who were at low risk for preeclampsia. Women were randomly assigned to begin daily supplementation with 1000 mg of vitamin C and 400 IU of vitamin E or matching placebo between the 9th and 16th weeks of pregnancy. The primary outcome was severe pregnancy-associated hypertension alone or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, medically indicated preterm birth, fetal-growth restriction, or perinatal death.

Results: A total of 10,154 women underwent randomization. The two groups were similar with respect to baseline characteristics and adherence to the study drug. Outcome data were available for 9969 women. There was no significant difference between the vitamin and placebo groups in the rates of the primary outcome (6.1% and 5.7%, respectively; relative risk in the vitamin group, 1.07; 95% confidence interval [CI], 0.91 to 1.25) or in the rates of preeclampsia (7.2% and 6.7%, respectively; relative risk, 1.07; 95% CI, 0.93 to 1.24). Rates of adverse perinatal outcomes did not differ significantly between the groups.

Conclusions: Vitamin C and E supplementation initiated in the 9th to 16th week of pregnancy in an unselected cohort of low-risk, nulliparous women did not reduce the rate of adverse maternal or perinatal outcomes related to pregnancy-associated hypertension (ClinicalTrials.gov number, NCT00135707).

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Figure 1
Figure 1. Enrollment, Randomization, and Follow-up of Study Participants
IRB denotes institutional review board.
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References

    1. Redman CW, Sargent IL. Latest advances in understanding preeclampsia. Science. 2005;308:1592–4. - PubMed
    1. Hubel CA. Oxidative stress in the pathogenesis of preeclampsia. Proc Soc Exp Biol Med. 1999;222:222–35. - PubMed
    1. Roggensack AM, Zhang Y, Davidge ST. Evidence for peroxynitrite formation in the vasculature of women with preeclampsia. Hypertension. 1999;33:83–9. - PubMed
    1. Zusterzeel PL, Rutten H, Roelofs HM, Peters WH, Steegers EA. Protein carbonyls in decidua and placenta of pre-eclamptic women as markers for oxidative stress. Placenta. 2001;22:213–9. - PubMed
    1. Hubel CA, McLaughlin MK, Evans RW, Hauth BA, Sims CJ, Roberts JM. Fasting serum triglycerides, free fatty acids, and malondialdehyde are increased in preeclampsia, are positively correlated, and decrease within 48 hours post partum. Am J Obstet Gynecol. 1996;174:975–82. - PubMed

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