Diabetes and Pre-Eclampsia Intervention Trial (DAPIT). [FUNDER: Wellcome Trust].

  • McCance, David R (Principal Investigator)
  • Szczepura, Ala (Co-Investigator)

Project: Project at former HEI

Project Details

Description

PROJECT FUNDING: Wellcome Trust (£865,157)

Background
Results of several trials of antioxidant use during pregnancy have not shown a reduction in pre-eclampsia, but the effect in women with diabetes is unknown.
We aimed to assess whether supplementation with vitamins C and E reduced incidence of pre-eclampsia in women with type 1 diabetes.

Methods
We enrolled women from 25 UK antenatal metabolic clinics in a multicentre randomised placebo-controlled trial. Eligibility criteria were type 1 diabetes preceding pregnancy, presentation between 8 weeks’ and 22 weeks’ gestation, singleton pregnancy, and age 16 years or older. Women were randomly allocated in a 1:1 ratio to receive 1000 mg vitamin C and 400 IU vitamin E (α-tocopherol) or matched placebo daily until delivery. The randomisation sequence was stratified by centre with balanced blocks of eight patients. All trial personnel and participants were masked to treatment allocation. The primary endpoint was pre-eclampsia, which we defined as gestational hypertension with proteinuria. Analysis was by modified intention to treat.

The study is registered, ISRCTN27214045.
StatusFinished
Effective start/end date1/06/021/01/12