Document Detail


Vitamins C and E to prevent complications of pregnancy-associated hypertension.
MedLine Citation:
PMID:  20375405     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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).
Authors:
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; Garland B Anderson;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  The New England journal of medicine     Volume:  362     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-04-08     Completed Date:  2010-04-15     Revised Date:  2014-09-14    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1282-91     Citation Subset:  AIM; IM    
Copyright Information:
2010 Massachusetts Medical Society
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00135707
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MeSH Terms
Descriptor/Qualifier:
Adult
Antioxidants / therapeutic use*
Ascorbic Acid / therapeutic use*
Double-Blind Method
Drug Combinations
Female
Humans
Hypertension, Pregnancy-Induced / prevention & control*
Oxidative Stress / drug effects
Parity
Pre-Eclampsia / prevention & control*
Pregnancy
Pregnancy Complications / prevention & control
Pregnancy Outcome
Pregnancy Trimester, First
Treatment Failure
Vitamin E / therapeutic use*
Young Adult
Grant Support
ID/Acronym/Agency:
HD21410/HD/NICHD NIH HHS; HD27860/HD/NICHD NIH HHS; HD27869/HD/NICHD NIH HHS; HD27915/HD/NICHD NIH HHS; HD27917/HD/NICHD NIH HHS; HD34116/HD/NICHD NIH HHS; HD34136/HD/NICHD NIH HHS; HD34208/HD/NICHD NIH HHS; HD36801/HD/NICHD NIH HHS; HD40485/HD/NICHD NIH HHS; HD40500/HD/NICHD NIH HHS; HD40512/HD/NICHD NIH HHS; HD40544/HD/NICHD NIH HHS; HD40545/HD/NICHD NIH HHS; HD40560/HD/NICHD NIH HHS; HD53097/HD/NICHD NIH HHS; HD53118/HD/NICHD NIH HHS; M01 RR000080/RR/NCRR NIH HHS; M01 RR000080-45/RR/NCRR NIH HHS; M01 RR00080/RR/NCRR NIH HHS; R24 HD050924/HD/NICHD NIH HHS; R24 HD050924-07/HD/NICHD NIH HHS; U10 HD021410/HD/NICHD NIH HHS; U10 HD021410-22/HD/NICHD NIH HHS; U10 HD027860-09/HD/NICHD NIH HHS; U10 HD027869-10S1/HD/NICHD NIH HHS; U10 HD027915-19/HD/NICHD NIH HHS; U10 HD027917-18/HD/NICHD NIH HHS; U10 HD034116-13/HD/NICHD NIH HHS; U10 HD034136-10S2/HD/NICHD NIH HHS; U10 HD034208-12/HD/NICHD NIH HHS; U10 HD036801/HD/NICHD NIH HHS; U10 HD036801-11/HD/NICHD NIH HHS; U10 HD040485-01/HD/NICHD NIH HHS; U10 HD040500-11/HD/NICHD NIH HHS; U10 HD040512-11/HD/NICHD NIH HHS; U10 HD040544-01/HD/NICHD NIH HHS; U10 HD040545-11/HD/NICHD NIH HHS; U10 HD040560-01/HD/NICHD NIH HHS; U10 HD053097/HD/NICHD NIH HHS; U10 HD053097-06/HD/NICHD NIH HHS; U10 HD053118-06/HD/NICHD NIH HHS; UL1 RR024153/RR/NCRR NIH HHS; UL1 RR024153/RR/NCRR NIH HHS; UL1 RR024153-05/RR/NCRR NIH HHS; UL1 RR024989/RR/NCRR NIH HHS; UL1 RR024989/RR/NCRR NIH HHS; UL1 RR024989-03/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Antioxidants; 0/Drug Combinations; 1406-18-4/Vitamin E; PQ6CK8PD0R/Ascorbic Acid
Investigator
Investigator/Affiliation:
S Caritis / ; T Kamon / ; M Cotroneo / ; D Fischer / ; P Reed / ; S Quinn / ; V Morby / ; F Porter / ; R Silver / ; J Miller / ; K Hill / ; D J Rouse / ; A Northen / ; P Files / ; J Grant / ; M Wallace / ; K Bailey / ; S Bousleiman / ; R Alcon / ; K Saravia / ; F Loffredo / ; A Bayless / ; C Perez / ; M Lake / ; M Talucci / ; K Boggess / ; K Dorman / ; J Mitchell / ; K Clark / ; S Timlin / ; J Bailit / ; C Milluzzi / ; W Dalton / ; C Brezine / ; D Bazzo / ; J Sheffield / ; L Moseley / ; M Santillan / ; K Buentipo / ; J Price / ; L Sherman / ; C Melton / ; Y Gloria-McCutchen / ; B Espino / ; M Dinsmoor / ; T Matson-Manning / ; G Mallett / ; S Blackwell / ; K Cannon / ; S Lege-Humbert / ; Z Spears / ; J Tillinghast / ; M Seebeck / ; F Johnson / ; S Fyffe / ; C Latimer / ; S Frantz / ; S Wylie / ; M Talucci / ; M Hoffman / ; J Benson / ; Z Reid / ; C Tocci / ; P Meis / ; M Swain / ; L Davis / ; E Lairson / ; S Butcher / ; S Maxwell / ; D Fisher / ; J Moss / ; B Stratton / ; G Hankins / ; J Brandon / ; C Nelson-Becker / ; G Norman / ; S Blackwell / ; P Lockhart / ; D Driscoll / ; M Dombrowski / ; R Clifton / ; T Boekhoudt / ; L Leuchtenburg / ; V Pemberton / ; J Cutler / ; W Barouch / ; S Tolivaisa /
Comments/Corrections

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