StAmP

• Research type

  Research Study

• Full title

  A Proof of Principle, Double-Blind, Randomised Placebo-Controlled,Multi-centre Trial of pravaStatin to Ameliorate Early Onset Pre-eclampsia

• IRAS ID

  3531

• Contact name

  David Williams

• Sponsor organisation

  University College London

• Eudract number

  2009-012968-13

• ISRCTN Number

  ISRCTN23410175

• Research summary

  Pre-eclampsia is a multi-system syndrome of pregnancy defined by gestational onset hypertension and protein in the urine. Pre-eclampsia, before 32 weeks?? gestation is associated with substantial morbidity and mortality for mother and baby. As yet there is no effective treatment for pre-eclampsia other than delivery of the baby. Recent research has identified that the placenta releases factors into maternal blood before the onset of pre-eclampsia. Initial studies suggest that statins can reduce the level of these factors, and perhaps reduce or eliminate the effects of pre-eclampsia. This trial aims to establish whether pravastatin causes a significant reduction of these placental factors in women with early-onset pre-eclampsia. To test this hypothesis, we will ask the following questions:1.Does pravastatin cause a greater inhibition of circulating placental factors in women with early-onset pre-eclampsia compared with placebo? 2.Are there any beneficial or adverse effects to the mother or the baby following gestational exposure to pravastatin during pre-eclampsia?3.If pravastatin appears to safely inhibit circulating placental factors, how best can a substantive trial/health technology assessment be undertaken to develop guidance for routine use of statins to prevent or ameliorate pre-eclampsia? StAmP is a double blind, placebo controlled multicentre randomised trial of pravastatin to ameliorate early onset pre-eclampsia. We aim to recruit 128 women with early onset pre-eclampsia from 8 hospitals in Birmingham, Liverpool, London and Edinburgh. Women will be randomised to receive either pravastatin or placebo and treatment will continue once daily until delivery. Women and their fetus will be monitored and clinical outcome data collected daily until delivery. Routine monitoring includes blood samples with occasional additional blood sample for the purposes of this study. The blood sample will be used to measure specific blood biomarkers thought to be important in pre-eclampsia. All women will be followed up until discharge from hospital post-delivery and again 6-weeks post delivery.

• REC name

  Wales REC 3

• REC reference

  10/MRE09/10

• Date of REC Opinion

  6 Sep 2010

• REC opinion

  Further Information Favourable Opinion