NCT05123677

Cardiac Output Monitoring to Predict Pre-Eclampsia and Restricted Growth (COMPaRE)

Serial Maternal Haemodynamic Monitoring in Pregnancy for the Prediction of Pre-eclampsia and Fetal Growth Restriction in a High-risk Population

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Sandwell & West Birmingham Hospitals NHS Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fetal Growth Retardation
• Pre-Eclampsia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Non-invasive haemodynamic assessment	Maternal non-invasive haemodynamic assessment: a pressure cuff (similar to the one used to measure blood pressure) is applied to the arm and thigh, and a further neck sensor applied. Information about the function of heart and major blood vessels are recorded
DIAGNOSTIC_TEST	Maternal ophthalmic artery doppler	Maternal ophthalmic artery doppler: an ultrasound probe is applied gently over the eyelid for a few seconds to study the blood flow of the main artery to the eye

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-06-01
• Completion: 2023-08-01
• First posted: 2021-11-17
• Last updated: 2021-11-17