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

NCT05123677 | Unknown

• 1 other identifier: 21MATE01
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fetal Growth Retardation; Pre-Eclampsia

Outcome Measures

Primary Outcomes (2)

• Diagnosis of pre-eclampsia

  This is defined as hypertension of \>140/90 mmHg and significant proteinuria. This is defined as urinalysis showing proteinuria of \>1+ or laboratory-quantified urine protein:creatinine ratio of \>30mg/mmol. These are assessed at every study visit.

  From 20 weeks gestation to 12 weeks post-partum.

• Diagnosis of fetal growth restriction

  This is diagnosed on ultrasound or at birth. During ultrasound scans at visits 2 and 3, fetal weight is estimated using the Hadlock formula from measurements of the fetal abdominal circumference, femur length and head circumference. This is then plotted onto customised growth chart. Fetal growth restriction is diagnosed antenatally when the estimated fetal weight is under the 3rd centile or under the 10th centile in the presence of abnormal ultrasound dopplers. Abnormal ultrasound dopplers are defined as raised pulsatility index in the fetal umbilical artery, middle cerebral artery or ductus venosus. At birth, fetal growth restriction is diagnosed when the measured birthweight plots under the 10th centile on the customised growth chart.

  From 20 weeks gestation to birth.

Secondary Outcomes (6)

• Pregnancy outcome

  From birth to 12 weeks of age

• Gestational age at delivery

  At delivery

• Birthweight centile

  At birth

• Duration of neonatal unit admission

  At delivery

• Intrapartum or immediate postpartum complications.

  From the onset of active labour (4cm cervical dilatation and regular contractions of 3-4:10 minutes) till 48 hours post-delivery

Study Arms (2)

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.

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

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.

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

Interventions

Non-invasive haemodynamic assessment 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

High Risk; Low Risk

Maternal ophthalmic artery doppler 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; Low Risk

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant patients who book in the first trimester at Birmingham City Hospital within the specified study dates.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sandwell & West Birmingham Hospitals NHS Trust: lead

MeSH Terms

Conditions

Fetal Growth Retardation; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced

Central Study Contacts

Nadiah Arrifin, MBBS BSc

CONTACT

01215531831; nadiahhashim.arrifin@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fetal Medicine Clinical Research Fellow

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 17, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share