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

Sandwell & West Birmingham Hospitals NHS Trust200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Fetal Growth Retardation Pre-Eclampsia

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: From 20 weeks gestation to birth.

Secondary Outcomes

Pregnancy outcome

This is concerned with the 3 possible outcomes of the pregnancy: livebirth, stillbirth or neonatal death.

Time frame: From birth to 12 weeks of age

Gestational age at delivery

This is the recorded age of gestation at the time of delivery, in weeks and days

Time frame: At delivery

Birthweight centile

This is a measure of the baby's weight at birth, in grams. This is then plotted onto a customised growth chart, accounting for maternal ethnicity and body mass index.

Time frame: At birth

Duration of neonatal unit admission

This is concerned with whether the baby is admitted to the neonatal admission unit following delivery. If admitted, duration would be quantified in days and hours.

Time frame: At delivery

Intrapartum or immediate postpartum complications.

This is concerned with the development of complications in the mother, in relation to haemorrhage and hypertensive disorders.

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

Persistence of maternal haemodynamic changes

Maternal haemodynamic changes assessed postpartum showing the persistence of haemodynamic changes noted antenatally

Time frame: 6-12 weeks postpartum (during study visit 4)