Clinical trial NCT05123677: Cardiac Output Monitoring to Predict Pre-Eclampsia and Restricted Growth (COMPaRE)
Official title: Serial Maternal Haemodynamic Monitoring in Pregnancy for the Prediction of Pre-eclampsia and Fetal Growth Restriction in a High-risk Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Growth Retardation
Pre-Eclampsia
Lead sponsor: Sandwell & West Birmingham Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant patients who book in the first trimester at Birmingham City Hospital within the specified study dates.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of pre-eclampsia
timeFrame: From 20 weeks gestation to 12 weeks post-partum.
measure: Diagnosis of fetal growth restriction
timeFrame: From 20 weeks gestation to birth.
Secondary outcomes:
measure: Pregnancy outcome
timeFrame: From birth to 12 weeks of age
measure: Gestational age at delivery
timeFrame: At delivery
measure: Birthweight centile
timeFrame: At birth
measure: Duration of neonatal unit admission
timeFrame: At delivery
measure: Intrapartum or immediate postpartum complications.
timeFrame: From the onset of active labour (4cm cervical dilatation and regular contractions of 3-4:10 minutes) till 48 hours post-delivery
measure: Persistence of maternal haemodynamic changes
timeFrame: 6-12 weeks postpartum (during study visit 4)
Other outcomes:
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