PARROT Ireland Version 7.0
Research type
Research Study
Full title
Placental growth factor in Assessment of women with suspected pre-eclampsia to Reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial
IRAS ID
210306
Contact name
Louise Kenny
Contact email
Sponsor organisation
University College Cork
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 16 days
Research summary
High blood pressure is a common problem in pregnancy, affecting about 10-15% of women. Whilst most cases of raised blood pressure are not serious, about 2-8% of pregnant women develop a potentially dangerous condition known as pre-eclampsia (PET). PET causes high blood pressure and protein in the urine, but many organs in the body can be affected and it may even lead to death of the mother or the baby. The baby may not grow properly and may need to be delivered early. At present, we do not have an effective test to tell the difference between women with the symptoms of PET who will develop complications, and those that will do well, and can be managed as an out-patient. We have recently evaluated a new blood test, called Placental Growth Factor (PlGF), to see whether it can help diagnose PET and the results are very promising. We studied 625 women and found that low values of PlGF are present in women with PET and that the test seems particularly good at picking up cases likely to present problems such as babies who are small and need early delivery.
In this proposed trial we will now add this test to standard hospital tests and normal medical examination. We will perform this study in pregnant women who come to hospital with raised blood pressure in seven hospital maternity units across the island of Ireland over a 24-month period. We will study how accurate it is at detecting severe pre-eclampsia and how effective it is at reducing adverse outcomes for mothers and babies. We will also assess whether the test can reduce health care costs for both mothers and hospitals.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0484
Date of REC Opinion
21 Nov 2016
REC opinion
Favourable Opinion