COMPaRE: Cardiovascular Monitoring to Predict PET & Restricted Growth
Research type
Research Study
Full title
Serial Maternal Haemodynamic Monitoring in Pregnancy for the Prediction of Pre-eclampsia and Fetal Growth Restriction in a High-Risk Population
IRAS ID
302511
Contact name
Nadiah H Arrifin
Contact email
Sponsor organisation
Sandwell & West Birmingham NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Pre-eclampsia (PET) and fetal growth restriction (FGR) are common complications of pregnancy that affect up to 15% of pregnancies in the UK. They have can have potentially devastating consequences to mothers and babies in pregnancy. Pre-term birth, that is often medically indicated to treat severe PET and FGR can cause cerebral palsy, breathing difficulty, developmental delay and even death in affected babies. Mothers who suffer from PET are at risk of seizures, strokes, multi-organ failure and future chronic hypertension. It is now thought that PET and FGR may result from poor adaptation of the maternal cardiovascular system to normal pregnancy. Our project aims to study the patterns within the maternal cardiovascular system and haemodynamic profile in women who are at high risk of PET and FGR by using non-invasive methods to gather information about the functions of their hearts and major blood vessels. We hope to elucidate the patterns that may give us an early warning to mothers who may develop PET and whose fetuses may be growth restricted. This would be an opportunity to more closely monitor, modify risk factors and treat earlier women who develop these conditions. Women who are at a high risk of PET and FGR as stipulated in the relevant Royal College of Obstetrics & Gynaecology and National Institute of Clinical Excellence guidelines and who give their consent will be eligible for the study.
The study will be conducted at Birmingham City Hospital and will last a total of 2 years. Participants will be recruited at the time of booking according to the criteria above. They will be then followed up in pregnancy and post-delivery with 4 study visits. Non-invasive haemodynamic information, ultrasound scan, blood pressure reading and urine dipstick analysis will be performed at each visit.
REC name
London - Surrey Research Ethics Committee
REC reference
21/PR/1630
Date of REC Opinion
11 Jan 2022
REC opinion
Further Information Favourable Opinion