A pregnancy complicated by pre-eclampsia can mean a hospital admission for the mother, and may mean that her baby is delivered prematurely. For further information about pre-eclampsia, please click here. Pre-eclampsia is a disorder of pregnancy which is predominantly marked by high blood pressure and protein in the urine and is associated with oxidative stress. Theoretically, supplementation with antioxidants may improve or even prevent the disease.

The VIP pilot trial was funded by Tommy's through the Maternal & Fetal Research Unit at St Thomas' Hospital, London. It was a pilot trial to test if supplements of vitamin C and vitamin E could prevent women at higher risk of pre-eclampsia from developing it.

Women at risk of pre-eclampsia were found to have an abnormal blood flow to the womb (seen on a scan). These women were then given vitamin C and E supplements from 20 weeks of pregnancy. These vitamins are antioxidants, which act by mopping up any free radicals. Free radicals are toxic molecules produced by the placenta in women with pre-eclampsia and are thought to cause the high blood pressure and other problems associated with pre-eclampsia.

Treatment with 1g of vitamin C and 400iu of vitamin E per day was found to reduce the women's risk of developing pre-eclampsia by more than 50%. The initial results are very exciting and were published in the Lancet in September 1999.

The clinical management of pregnant women with pre-eclampsia in the UK could change as a result of this trial.

A large multicentre randomised clinical trial based in the UK will commence recruitment in July 2003 to determine whether supplementation with vitamin C and vitamin E leads to a reduction in the incidence of pre-eclampsia in women with known risk factors.

Basic details about the trial are shown below. If you would like further information or to find out if you could be eligible to take part, please contact the research team directly at St Thomas' Hospital (details below) or contact Tommy's information team on 0870 777 30 60, email info@tommys.org

UK Centres. Research Midwives will be based in the following centres but will also recruit women in identified proximal units.

Birmingham
Bradford
Bristol
Leeds
Leicester
Liverpool
London - Guys & St Thomas' and Hammersmith & Queen Charlotte's
Maidstone
Manchester
Newcastle
Oxford

Eligibility criteria
Inclusion Criteria:

All pregnant women 14+0 to 21+6 weeks' gestation, with one (or more) of the following risk factors

• Chronic hypertension
• Pre-gestational diabetes
• SLE with current or past renal dysfunction
• Antiphospholipid syndrome (APS)
• Chronic renal disease
• Abnormal uterine artery Doppler waveforms (as defined by Chappell et al, 1999) identified between 18 and 22 weeks gestation
• Multiple pregnancy
• Previous history in the preceding pregnancy of:
  • Pre-eclampsia
  • Eclampsia
  • HELLP syndrome

Exclusion Criteria:

• Inability to give informed consent
• Daily intake of supplements of vitamin C >200mg and vitamin E >50iu (Pregnancy specific multivitamins do not lead to exclusion)
• Women taking Warfarin (due to the theoretical potentiation of Warfarin by vitamin E).

Intervention: 1000mg Vitamin C, 400iu vitamin E/daily or placebo/daily

Main Outcomes: Incidence of pre-eclampsia, birthweight (5th centile)

Number to be recruited: 2,394

Date recruitment started/planned: July 2003

Date recruitment finished/planned: April 2005

New centres needed: No

Funding Source: Wellcome Trust

Contact name and address:
Professor L Poston, Mr A Shennan, Principle Investigators
Mrs Annette Briley, Clinical Trial Midwifery Manager

Maternal and Fetal Research Unit
Department of Women's Health
10th Floor North Wing
St Thomas' Hospital
Lambeth Palace Road
London SE1 7EH
Tel: 020 7188 3641