Extrait

Background and study aims Preeclampsia (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. It is therefore very important that the signs of PE are spotted quickly so that the mother can be treated. The early signs of PE include high blood pressure (hypertension) and the presence of protein in the urine (proteinuria), however having these symptoms does not guarantee that a woman will develop it. Currently, there is no way of testing to find out who will develop the disease, and so patients with suspected PE are admitted to hospital, often for several days in order to make the diagnosis. Over 50% of the patients admitted don't have PE, which can be a great cause of stress and anxiety to the mother, and a waste of valuable resources in the NHS. sFlt-1 and PLGF are natural chemicals produced by the placenta and released into the mother’s blood. Recent studies have shown that in cases of PE, the amounts of these markers in the blood are different to normal. The aim of this study is to find out whether testing sFlt-1 and PLGF in the blood is a reliable way of predicting the chance of a woman developing PE. Who can participate? Adult women who are more than 24 weeks pregnant who are showing signs of PE. What does the study involve? Women who are showing signs of PE have a blood sample taken so that the amounts of sFlt-1 and PLGF in the blood can be measured. The women are then randomly allocated to one of two groups. For women in the first group, the result of the test is not revealed to the team looking after her, and she continues with the usual practice (being admitted to hospital and monitored). For women in the second group, the result of the test is given to the team looking after her so that they can make a decision about whether to admit her to hospital (based on the likelihood of her developing PE). If they feel that she has a low risk of developing PE, then she can be monitored as an outpatient. The accuracy of the test is then determined by seeing how many women develop PE and comparing them to the prediction from the test. What are the possible benefits and risks of participating? There are no direct benefits or risks of taking part in this study. Where is the study run from? Nuffield Department of Obstetrics and Gynaecology, Oxford (UK) When is the study starting and how long is it expected to run for? June 2015 to June 2016 Who is funding the study? Roche Diagnostics Ltd (UK) Who is the main contact? Ms Georgina Longley

Critère d'inclusion

• Topic: Reproductive Health & Childbirth; Subtopic: Reproductive Health & Childbirth; Disease: Reproductive Health & Childbirth

Liens

• ictrp
• isrctn