A randomised controlled trial of vitamin C and E supplementation to prevent pre-eclampsia in women at risk

Not Applicable

Completed

• Conditions: Pre-eclampsia; Pregnancy and Childbirth

• Registration Number: ISRCTN62368611
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11-17
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2400

Inclusion Criteria

Women with identified additional risk factors for pre-eclampsia in ten geographical areas, and 22 hospitals through England:
1. Pregnant women between 14 and 22 weeks' gestation
2. A history of pre-eclampsia (requiring delivery less than 37 weeks) in preceding pregnancy, eclampsia or Haemolysis, Elevated Liver enzyme levels and Low Platelet count (HELLP) syndrome (at any time)
3. Women with essential hypertension, diabetes (requiring treatment), Systemic Lupus Erythrematosus (SLE)/Anti-Phospholipid antibody Syndrome (APS) with renal imvolvement
4. In the current pregnancy: abnormal uterine artery Dopplers (18 to 22 weeks), multiple pregnancy, diastolic Blood Pressure (BP) more than 90 mmHg (before 20 weeks)
5. Primparous women with Body Mass Index (BMI) more than 30

Exclusion Criteria

1. Inability/unwillingness to give informed consent
2. Women taking warfarin (due to the theoretical potentiation of warfarin by Vitamin E)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence of pre-eclampsia<br>2. Birthweight

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures