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

Sandwell & West Birmingham Hospitals NHS Trust

Status: Unknown

Conditions: Pre-Eclampsia; Fetal Growth Retardation

Treatments: Diagnostic Test: Non-invasive haemodynamic assessment; Diagnostic Test: Maternal ophthalmic artery doppler

Study type: Observational

Funder types: Other

Identifiers

NCT05123677

21MATE01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women aged ≥18 at time of conception
• Case subjects are at high risk of PET by NICE guidelines ( ≥1 high risk factor or >1 moderate risk factor) or high risk of SGA by RCOG Guidelines (≥1 major risk factor or ≥3 minor risk factors). Control subjects do not meet this criteria

Exclusion criteria

• Maternal age <18 years of age at time of booking
• Fetal structural or genetic abnormality
• Multiple pregnancy
• Known underlying maternal cardiac condition

Trial design

200 participants in 2 patient groups

Low Risk

Description:

These patients are screened to be low-risk for pre-eclampsia and fetal growth restriction by the guidelines set out by the National Institute for Health and Care Excellence; and the Royal College of Obstetricians \& Gynaecologists, respectively.

Treatment:

Diagnostic Test: Non-invasive haemodynamic assessment

Diagnostic Test: Maternal ophthalmic artery doppler

High Risk

Description:

These patients are screened to be high-risk for pre-eclampsia and fetal growth restriction by the guidelines set out by the National Institute for Health and Care Excellence; and the Royal College of Obstetricians \& Gynaecologists, respectively.

Treatment:

Diagnostic Test: Non-invasive haemodynamic assessment

Diagnostic Test: Maternal ophthalmic artery doppler