Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05123677
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2021-10-28
Brief Title:
Cardiac Output Monitoring to Predict Pre-Eclampsia and Restricted Growth COMPaRE
Sponsor:
Sandwell West Birmingham Hospitals NHS Trust
Organization:
Sandwell West Birmingham Hospitals NHS Trust
Study Overview
Official Title:
Serial Maternal Haemodynamic Monitoring in Pregnancy for the Prediction of Pre-eclampsia and Fetal Growth Restriction in a High-risk Population
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPaRE
Brief Summary:
Pre-eclampsia PET and fetal growth restriction FGR are common complications of pregnancy that affect up to 15 of pregnancies in the UK These conditions 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 This 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 The investigators hope to elucidate the patterns that may offer 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None