Newcastle Clinical Trials Unit



Effect of folic acid supplementation in pregnancy preeclampsia

  • Study stage: Closed
  • UK Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: Canadian Institute of Health Research (CIHR)
  • Therapeutic area: Reproductive Health and Childbirth (IVF)
  • Type of study: CTIMP

Aim: The overall aim of this randomized controlled trial is to evaluate a new preeclampsia (PE) prevention strategy of high dose folic acid supplementation from early (80/7 to 166/7weeks of gestation) pregnancy until delivery.

Primary Outcome:

Preeclampsia (PE) is the primary outcome measure.

PE is defined as blood pressure ≥d90 mmHg on two occasions ≥4 hours apart and proteinuria developed in women greater than 20 weeks of gestation.

  • Population: Adult
  • Phase: III
  • Design: RCT
  • Setting: Secondary Care
  • Planned Sample Size: 3064