Fetal Growth RetardationCOMPaRENCT05123677
Cardiac Output Monitoring to Predict Pre-Eclampsia and Restricted Growth (COMPaRE)
An observational study of Fetal Growth Retardation and Pre-Eclampsia, run by Sandwell & West Birmingham Hospitals NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Retardation, Pre-Eclampsia
- What is being tested?
- Non-invasive haemodynamic assessment and Maternal ophthalmic artery doppler
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant patients who book in the first trimester at Birmingham City Hospital within the specified study dates.
Who may be able to join
- 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
Who cannot join
- Maternal age <18 years of age at time of booking
- Fetal structural or genetic abnormality
- Multiple pregnancy
- Known underlying maternal cardiac condition
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serial Maternal Haemodynamic Monitoring in Pregnancy for the Prediction of Pre-eclampsia and Fetal Growth Restriction in a High-risk Population
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
- Being tested
- Non-invasive haemodynamic assessment, Maternal ophthalmic artery doppler
- Medical subject headings
- Fetal Growth Retardation, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive haemodynamic assessmentDiagnostic 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 dopplerDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Non-invasive haemodynamic assessment; Diagnostic Test: Maternal ophthalmic artery doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From 20 weeks gestation to birth.
Secondary outcomes (6)
Pregnancy outcome
This is concerned with the 3 possible outcomes of the pregnancy: livebirth, stillbirth or neonatal death.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6-12 weeks postpartum (during study visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nadiah Hashim Arrifin, Sandwell & West Birmingham Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123677
- Sponsor's protocol ID
- 21MATE01
- Acronym
- COMPaRE
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Maternal Haemodynamic Monitoring in Pregnancy for the Prediction of Pre-eclampsia and Fetal Growth Restriction in a High-risk Population
- ClinicalTrials.gov ID
- NCT05123677
- Acronym / sponsor ID
- COMPaRE / 21MATE01
- Conditions
- Fetal Growth Retardation, Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Risk | – | Diagnostic Test: Non-invasive haemodynamic assessment, Diagnostic Test: Maternal ophthalmic artery dopplerThese 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. |
| High Risk | – | Diagnostic Test: Non-invasive haemodynamic assessment, Diagnostic Test: Maternal ophthalmic artery dopplerThese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients who book in the first trimester at Birmingham City Hospital within the specified study dates.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Maternal age <18 years of age at time of booking
- Fetal structural or genetic abnormality
- Multiple pregnancy
- Known underlying maternal cardiac condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive haemodynamic assessmentMaternal 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 | Diagnostic test | High Risk, Low Risk |
| Maternal ophthalmic artery dopplerMaternal 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 | Diagnostic test | High Risk, Low Risk |
Primary outcome
Diagnosis of pre-eclampsia
Time frame: From 20 weeks gestation to 12 weeks post-partum.
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.
Diagnosis of fetal growth restriction
Time frame: From 20 weeks gestation to birth.
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.
6 secondary outcomes
Pregnancy outcome
Time frame: From birth to 12 weeks of age
Gestational age at delivery
Time frame: At delivery
Birthweight centile
Time frame: At birth
Duration of neonatal unit admission
Time frame: At delivery
Intrapartum or immediate postpartum complications.
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
Time frame: 6-12 weeks postpartum (during study visit 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation and Pre-Eclampsia, run by Sandwell & West Birmingham Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadiah Arrifin, MBBS BSc (01215531831 ext. 5182, nadiahhashim.arrifin@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of pre-eclampsia (time frame: From 20 weeks gestation to 12 weeks post-partum.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.