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

James M. Roberts, 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, 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 & 1 others Garland B. Anderson

Research output: Contribution to journalArticle

256 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1282-1291
Number of pages10
JournalNew England Journal of Medicine
Volume362
Issue number14
DOIs
StatePublished - Apr 8 2010

Fingerprint

Pregnancy Complications
Vitamin E
Ascorbic Acid
Hypertension
Pregnancy
Pre-Eclampsia
Vitamins
Placebos
Mothers
Confidence Intervals
Premature Birth
Random Allocation
Fetal Development
Thrombocytopenia
Creatinine
Seizures
Oxidative Stress
Perfusion
Antioxidants
Liver

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Roberts, J. M., Myatt, L., Spong, C. Y., Thom, E. A., Hauth, J. C., Leveno, K. J., ... Anderson, G. B. (2010). Vitamins C and E to prevent complications of pregnancy-associated hypertension. New England Journal of Medicine, 362(14), 1282-1291. https://doi.org/10.1056/NEJMoa0908056

Vitamins C and E to prevent complications of pregnancy-associated hypertension. / Roberts, James M.; Myatt, Leslie; Spong, Catherine Y.; Thom, Elizabeth A.; Hauth, John C.; Leveno, Kenneth J.; Pearson, Gail D.; Wapner, Ronald J.; Varner, Michael W.; Thorp, John M.; Mercer, Brian M.; Peaceman, Alan M.; Ramin, Susan M.; Carpenter, Marshall W.; Samuels, Philip; Sciscione, Anthony; Harper, Margaret; Smith, Wendy J.; Saade, George; Sorokin, Yoram; Anderson, Garland B.

In: New England Journal of Medicine, Vol. 362, No. 14, 08.04.2010, p. 1282-1291.

Research output: Contribution to journalArticle

Roberts, JM, Myatt, L, Spong, CY, Thom, EA, Hauth, JC, Leveno, KJ, Pearson, GD, Wapner, RJ, Varner, MW, Thorp, JM, Mercer, BM, Peaceman, AM, Ramin, SM, Carpenter, MW, Samuels, P, Sciscione, A, Harper, M, Smith, WJ, Saade, G, Sorokin, Y & Anderson, GB 2010, 'Vitamins C and E to prevent complications of pregnancy-associated hypertension', New England Journal of Medicine, vol. 362, no. 14, pp. 1282-1291. https://doi.org/10.1056/NEJMoa0908056
Roberts JM, Myatt L, Spong CY, Thom EA, Hauth JC, Leveno KJ et al. Vitamins C and E to prevent complications of pregnancy-associated hypertension. New England Journal of Medicine. 2010 Apr 8;362(14):1282-1291. https://doi.org/10.1056/NEJMoa0908056
Roberts, James M. ; Myatt, Leslie ; Spong, Catherine Y. ; Thom, Elizabeth A. ; Hauth, John C. ; Leveno, Kenneth J. ; Pearson, Gail D. ; Wapner, Ronald J. ; Varner, Michael W. ; Thorp, John M. ; Mercer, Brian M. ; Peaceman, Alan M. ; Ramin, Susan M. ; Carpenter, Marshall W. ; Samuels, Philip ; Sciscione, Anthony ; Harper, Margaret ; Smith, Wendy J. ; Saade, George ; Sorokin, Yoram ; Anderson, Garland B. / Vitamins C and E to prevent complications of pregnancy-associated hypertension. In: New England Journal of Medicine. 2010 ; Vol. 362, No. 14. pp. 1282-1291.
@article{24c4e383e624454d92c12fd20376c9e2,
title = "Vitamins C and E to prevent complications of pregnancy-associated hypertension",
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.",
author = "Roberts, {James M.} and Leslie Myatt and Spong, {Catherine Y.} and Thom, {Elizabeth A.} and Hauth, {John C.} and Leveno, {Kenneth J.} and Pearson, {Gail D.} and Wapner, {Ronald J.} and Varner, {Michael W.} and Thorp, {John M.} and Mercer, {Brian M.} and Peaceman, {Alan M.} and Ramin, {Susan M.} and Carpenter, {Marshall W.} and Philip Samuels and Anthony Sciscione and Margaret Harper and Smith, {Wendy J.} and George Saade and Yoram Sorokin and Anderson, {Garland B.}",
year = "2010",
month = "4",
day = "8",
doi = "10.1056/NEJMoa0908056",
language = "English (US)",
volume = "362",
pages = "1282--1291",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "14",

}

TY - JOUR

T1 - Vitamins C and E to prevent complications of pregnancy-associated hypertension

AU - Roberts, James M.

AU - Myatt, Leslie

AU - Spong, Catherine Y.

AU - Thom, Elizabeth A.

AU - Hauth, John C.

AU - Leveno, Kenneth J.

AU - Pearson, Gail D.

AU - Wapner, Ronald J.

AU - Varner, Michael W.

AU - Thorp, John M.

AU - Mercer, Brian M.

AU - Peaceman, Alan M.

AU - Ramin, Susan M.

AU - Carpenter, Marshall W.

AU - Samuels, Philip

AU - Sciscione, Anthony

AU - Harper, Margaret

AU - Smith, Wendy J.

AU - Saade, George

AU - Sorokin, Yoram

AU - Anderson, Garland B.

PY - 2010/4/8

Y1 - 2010/4/8

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=77950847452&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77950847452&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa0908056

DO - 10.1056/NEJMoa0908056

M3 - Article

VL - 362

SP - 1282

EP - 1291

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 14

ER -