Journal
NEW ENGLAND JOURNAL OF MEDICINE
Volume 362, Issue 14, Pages 1282-1291Publisher
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa0908056
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Funding
- NCATS NIH HHS [UL1 TR000005] Funding Source: Medline
- NCRR NIH HHS [M01 RR000080, UL1 RR024153, M01 RR000080-45, M01 RR00080, UL1 RR024153-05, UL1 RR024989-03, UL1 RR024989] Funding Source: Medline
- NICHD NIH HHS [U10 HD053118-06, UG1 HD027869, U10 HD040500, U10 HD053118, U10 HD040485-01, U10 HD040512-11, HD36801, U01 HD036801, HD40485, U10 HD040544-01, U10 HD027860, U10 HD034116-13, UG1 HD040485, UG1 HD040545, U10 HD027915, HD40500, U10 HD034136-10S2, U10 HD040560, HD53118, UG1 HD053097, HD27860, U10 HD027869-10S1, U10 HD040545, UG1 HD027915, U10 HD021410-22, HD40512, HD40544, U10 HD053097-06, HD53097, U10 HD036801, U10 HD021410, UG1 HD040544, UG1 HD034208, HD27917, U10 HD040500-11, UG1 HD040512, HD40545, U10 HD034116, HD40560, U10 HD040545-11, U10 HD027917-18, U10 HD040560-01, U10 HD040512, R24 HD050924, U10 HD034208-12, UG1 HD040500, HD21410, U10 HD027869, U10 HD027917, HD34116, U10 HD027915-19, HD27915, HD34208, U10 HD027860-09, U10 HD053097, U10 HD034208, U10 HD040544, U10 HD036801-11, U10 HD040485, U10 HD034136, UG1 HD034116, HD27869, HD34136, UG1 HD040560] Funding Source: Medline
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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). N Engl J Med 2010;362:1282-91.
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