STATIN

• Research type

  Research Study

• Full title

  Randomised Controlled Trial with Pravastatin versus Placebo for Prevention of Preeclampsia

• IRAS ID

  220990

• Contact name

  Kypros Nicolaides

• Contact email

  kypros@fetalmedicine.com

• Sponsor organisation

  Fundación para la Formación e Investigación Sanitaria (FFIS)

• Eudract number

  2016-005206-19

• Duration of Study in the UK

  1 years, 3 months, 1 days

• Research summary

  Preeclampsia (PE) is an important cause of maternal and perinatal mortality and morbidity. A major challenge in modern obstetrics is early identification of pregnancies at high-risk of PE and undertaking the necessary measures to reduce the incidence of the disease.

  Extensive research has demonstrated that the development of PE can be predicted by a combination of maternal demographic characteristics and medical and obstetric history and biophysical markers including uterine artery pulsatility index (PI) and mean arterial pressure (MAP) and biochemical markers including maternal serum placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFLT-1).
  Although screening at 11-13, 20-24 and 30-34 weeks is effective at identifying pregnancies at high-risk of developing PE at <37 weeks’ gestation (preterm-PE) the performance of screening for term-PE is poor. Large multicentre studies have shown that although adverse outcomes for the mother and baby are more serious with preterm-PE the contribution of term-PE to such adverse outcomes is at least as high because the condition is much more common (incidence 0.5-0.7% for preterm-PE and 2-2.5% for term-PE). For example, in half of the maternal deaths from hypertensive disorders of pregnancy in the UK and Ireland at 2009-2014, the death occurred at >37 weeks gestation.

  Effective screening for term-PE can be achieved by a combination of maternal factors, MAP, PLGF and sFLT-1 at the time of a routine ultrasound scan to monitor fetal growth at 35-37 weeks of gestation.

  The objective of this study is to examine if the prophylactic use of pravastatin from 35-37 weeks’ gestation in women at increased risk for term-PE can reduce the incidence and severity of the disease.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  17/LO/0130

• Date of REC Opinion

  20 Feb 2017

• REC opinion

  Further Information Favourable Opinion