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

NCT ID: NCT05123677

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-08-01

Brief Summary

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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

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Conditions

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Fetal Growth Retardation Pre-Eclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Low Risk

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.

Non-invasive haemodynamic assessment

Intervention Type DIAGNOSTIC_TEST

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

Maternal ophthalmic artery doppler

Intervention Type DIAGNOSTIC_TEST

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

High Risk

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.

Non-invasive haemodynamic assessment

Intervention Type DIAGNOSTIC_TEST

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

Maternal ophthalmic artery doppler

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sandwell & West Birmingham Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Dr Nadiah Hashim Arrifin

Fetal Medicine Clinical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Nadiah Arrifin, MBBS BSc

Role: CONTACT

Phone: 01215531831

Email: [email protected]

Other Identifiers

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21MATE01

Identifier Type: -

Identifier Source: org_study_id