World Health Organisation multicentre randomised trial of supplementation with vitamins C and E among pregnant women at high risk for pre-eclampsia in populations of low nutritional status from developing countries.
OBJECTIVE
To determine if vitamin C and E supplementation in high-risk pregnant women with low nutritional status reduces pre-eclampsia.


METHODS
Multicentred, randomised, controlled, double-blinded trial.


METHODS
Antenatal care clinics and Hospitals in four countries.


METHODS
Pregnant women between 14 and 22 weeks' gestation.


METHODS
Randomised women received 1000 mg vitamin C and 400 iu of vitamin E or placebo daily until delivery.


METHODS
Pre-eclampsia, low birthweight, small for gestational age and perinatal death.


RESULTS
Six hundred and eighty-seven women were randomised to the vitamin group and 678 to the placebo group. Groups had similar gestational ages (18.1; SD 2.4 weeks), socio-economic, clinical and demographical characteristics and blood pressure at trial entry. Risk factors for eligibility were similar, except for multiple pregnancies: placebo group (14.7%), vitamins group (11.8%). Previous pre-eclampsia, or its complications, was the most common risk factor at entry (vitamins 41.6%, placebo 41.3%). Treatment compliance was 87% in the two groups and loss to follow-up was low (vitamins 2.0%, placebo 1.3%). Supplementation was not associated with a reduction of pre-eclampsia (RR: 1.0; 95% CI: 0.9-1.3), eclampsia (RR: 1.5; 95% CI: 0.3-8.9), gestational hypertension (RR: 1.2; 95% CI: 0.9-1.7), nor any other maternal outcome. Low birthweight (RR: 0.9; 95% CI: 0.8-1.1), small for gestational age (RR: 0.9; 95% CI: 0.8-1.1) and perinatal deaths (RR: 0.8; 95% CI: 0.6-1.2) were also unaffected.


CONCLUSIONS
Vitamins C and E at the doses used did not prevent pre-eclampsia in these high-risk women.
Nuffield Department of Obstetrics and Gynaecology, Oxford Maternal and Perinatal Health Institute, Green Templeton College, University of Oxford, Oxford, UK. jose.villar@obs-gyn.ox.ac.uk
J
J
Villar
M
M
Purwar
M
M
Merialdi
N
N
Zavaleta
N
N
Thi Nhu Ngoc
J
J
Anthony
A
A
De Greeff
L
L
Poston
A
A
Shennan
D000328:Adult; D001205:Ascorbic Acid / Q000627:therapeutic use*; D003906:Developing Countries; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007236:Infant, Small for Gestational Age; D009752:Nutritional Status; D011225:Pre-Eclampsia / Q000517:prevention & control*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011295:Prenatal Care / Q000379:methods; D039401:Prenatal Nutritional Physiological Phenomena; D016896:Treatment Outcome; D014810:Vitamin E / Q000627:therapeutic use*; D055815:Young Adult
D014810:Vitamin E; D001205:Ascorbic Acid