Extrait

Background and study aims Pre-eclampsia (PE) is a medical condition which can develop during pregnancy, and can affect both the mother and unborn baby. The exact cause of PE is not known, however it is thought to happen because of a problem with the placenta. The placenta is a specialised organ which connects the mother’s blood supply to the baby’s, providing the baby with food (nutrients) and oxygen. In PE, it is thought that the blood supply to the placenta is reduced, which can mean the unborn baby does not get enough nutrients to develop properly. The key indicators of PE are high blood pressure and protein in the mother’s urine. In order to identify as many cases as possible, all women have their blood pressure and urine monitored throughout pregnancy. If PE is diagnosed, the only cure is to deliver the baby. If this occurs before 37 weeks of pregnancy, the mother may need to be admitted to hospital for blood pressure treatment and monitoring for complications, whilst planning for safe delivery of the baby. Some women become unwell very quickly and need to have their babies delivered, while others have long stays in hospital for monitoring. It is not always possible to identify women at high risk of the severe complications of pre-eclampsia needing early delivery. This study will look at levels of a protein produced by the placenta called Placenta Growth Factor (PlGF). Previous studies have shown that women with very low PlGF levels are at greater risk of severe PE and stillbirth. The aim of this study is to find out whether measuring PIGF is a good predictor of PE Who can participate? Women who are between 20 and 36 weeks pregnant with suspected PE What does the study involve? All participants give an extra sample of blood at the time of assessment by their doctor or midwife for a PlGF blood test. The result of the test is revealed to the clinician at a randomly allocated timepoint, when the clinicians may then use the revealed result to help determine the management of the pregnancy, to help plan care for the participant. Participants at high risk of adverse events may receive intensive assessment and admission, and those at low risk are reassured and returned to routine care. What are the possible benefits and risks of participating? There are no anticipated risks to those taking part in the study. Where is the study run from? 1. Guy’s and St Thomas’ NHS Foundation Trust (UK) 2. St George’s University Hospitals NHS Foundation Trust (UK) 3. Kingston Hospital NHS Foundation Trust (UK) 4. West Middlesex University Hospital (UK) 5. Central Manchester University Hospital NHS Foundation Trust (UK) 6. Liverpool Women’s NHS Foundation Trust (UK) 7. Leeds Teaching Hospitals NHS Trust (UK) 8. Bradford Teaching Hospitals NHS Foundation Trust (UK) 9. Royal United Hospitals Bath (UK) 10. North Bristol NHS Trust (UK) 11. University Hospitals Bristol NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? April 2016 to March 2018 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Dr Kate Duhig

Critère d'inclusion

• Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine; UKCRC code/ Disease: Reproduction/ Other disorders originating in the perinatal period

Liens

• isrctn
• ictrp