Fetal Growth RestrictionHEARTNCT05423665
Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies
An observational study of Fetal Growth Restriction and Cardiac Remodeling, Ventricular, run by University Hospital, Ghent at 3 sites in 2 countries.
Trial summary
In this project there are 2 time points during the pregnancy included, namely at 21 weeks and 30 weeks of gestation, to measure the predictive values of FGR, strain and strain rate. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Growth Restriction, Cardiac Remodeling, Ventricular, Placental Insufficiency
- What is being tested?
- sample collection
- How many people
- 360 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Jun 2023to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- Adult
Study population: The number of subjects that will be included in this study is: 600 neonates (200 twin pairs and 200 singletons) and 400 pregnant mothers. The fetuses are divided into following sub-groups: * Appropriately grown * Fetal growth restricted * Selective fetal growth restricted (specific for twins)
Who may be able to join
- Singleton or dichorionic twin pregnancy
- Pregnant women 21 weeks ( ± 2 weeks) of gestation at the first visit
- Women ≥ 18 years
Who cannot join
- Women pregnant of multiples of higher order (≥3 siblings) Monochorionic twin pregnancy
- Fetal arrhythmia
- Known fetal congenital or genetic abnormalities
- Any suspicion of congenital fetal anomalies that might influence fetal cardiac function
- Pre-existing maternal hypertensive disease
- Autoimmune disease including systemic lupus erythematosus
- History of stillbirth
- Diabetes mellitus (mother)
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Belgium2 sites, 2 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Kristien Roelens, prof. dr.
- Not yet recruiting
Universitair ziekenhuis Leuven
Leuven, 3000
Liebeth Lewie, prof. dr.
Netherlands1 site, 1 recruiting
- Not yet recruiting
Maxima medical center
Eindhoven, 5631
Judith van Laar, dr.
About this study
Official title: Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth in Twin Pregnancies
In this project there are 2 time points during the pregnancy included, namely at 21 weeks and 30 weeks of gestation, to measure the predictive values of FGR, strain and strain rate. The fetal growth parameters will be collected at the same time points, to define the growth (differences) throughout gestation of both fetuses. A maternal blood sample will be taken at 21 weeks of gestation to identify the level of exposure to air pollution (black carbon) and the level of biochemical markers of placental dysfunction. Doppler ultrasounds will be used for antenatal identification of placenta insufficiency. At birth, umbilical cord blood and the placenta will be collected. The placenta will be examined, to identify morphological findings which are associated with FGR. The umbilical cord blood and placental biopsy will be used for the level of exposure to air pollution and the level of oxidative stress. One to three days after birth, neonatal strain and strain rate will be measured to define postnatal cardiac remodeling as well as the neonatal blood pressure as cardiovascular risk factor.
Read the detailed description
Fetal growth restriction (FGR) is diagnosed in 5-10% of the pregnancies. After preterm birth, it is the second leading cause of perinatal morbidity and mortality. Twin pregnancies have a higher occurrence of FGR than singletons, in monochorionic (MC) twin pregnancies it's diagnosed in 19.7% of the cases and in dichorionic (DC) twin pregnancies in 10.5% of the cases. Fetuses with FGR are at greater risk of perinatal morbidity and mortality and even long-term health defects. From a public health perspective, it's important to correctly diagnose FGR to adjust the antenatal and postnatal care and to have more insight into the factors influencing early onset cardiovascular disease. STE has a strong predictive value for cardiovascular function, therefore it would be a promising tool to add in the routine pregnancy clinical care. Speckle tracking echocardiography (STE) is a relative new technique especially in the pregnancy follow up, which permits offline calculation of myocardial velocities and deformation parameters. These parameters, including strain and strain rate, provide information about the fetal myocardial function. Apart from investigating if STE can be used for the prediction of FGR, we will also investigate the association between fetal exposure to air pollution and in utero cardiac remodeling. Indeed, it is known that inhalation of particulate matter (e.g. black carbon) during the pregnancy can reach the placenta and lead to alterations in the placenta's function including increases in oxidative stress markers. Early life exposure to black carbon has been associated with adverse cardiovascular health outcomes and reduction of fetal growth, especially in multiple gestation pregnancies.
In this project we will include 2 time points during the pregnancy, namely at 21 weeks and 30 weeks of gestation, to measure the predictive values of FGR, strain and strain rate. The fetal growth parameters will be collected at the same time points, to define the growth (differences) throughout gestation of both fetuses. A maternal blood sample will be taken at 20 weeks of gestation to identify the level of exposure to air pollution (black carbon) and the level of biochemical markers of placental dysfunction. Doppler ultrasounds will be used for antenatal identification of placenta insufficiency. At birth, umbilical cord blood and the placenta will be collected. The placenta will be examined, to identify morphological findings which are associated with FGR. The umbilical cord blood and placental biopsy will be used for the level of exposure to air pollution and the level of oxidative stress. One to three days after birth, neonatal strain and strain rate will be measured to define postnatal cardiac remodeling as well as the neonatal blood pressure as cardiovascular risk factor.
- Conditions
- Fetal Growth Restriction, Cardiac Remodeling, Ventricular, Placental Insufficiency, Air Pollution
- Being tested
- sample collection
- Medical subject headings
- Fetal Growth Retardation, Ventricular Remodeling, Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sample collectionOther
blood sample at 21 weeks of gestation clips of the fetal heart at 21 weeks of gestation, 30 weeks of gestation and 1-3 days after birth collection of umbilical cord blood at birth collection of the placenta at birth
| Study group | Role | What they receive |
|---|---|---|
| Fetal growth restricted | Observation of cardiac remodeling perinatal and postnatal Receives: Other: sample collection | |
| Appropriately grown | Observation of cardiac remodeling perinatal and postnatal Receives: Other: sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change in strain measured by speckle tracking echocardiography as a tool for early diagnosis of impaired fetal growth in multiple gestations
to determine the change in fetal strain and strain rate in twin pregnancies in comparison with fetal growth
Measured: Prenatal to 1-3 days after birth
To determine the intra-pair differences in fetal growth and strain (cardiac remodeling) in multiple gestations.
to compare changes in strain and strain rate with fetal growth within 1 twin pair
Measured: Prenatal to 1-3 days after birth
To compare the strain values (cardiac remodeling) between singletons and twin pregnancies
to compare the changes in strain and strain rate between singletons and twin pregnancies
Measured: Prenatal to 1-3 days after birth
Secondary outcomes (4)
To investigate the association between placenta functioning and in utero cardiac remodeling
to evaluate placenta insufficiency (Doppler ultrasound, biochemical marker) with strain and strain rate
Measured: Prenatal to 1-3 days after birth
To explore in utero cardiac remodeling in association with neonatal cardiovascular health
to evaluate strain and strain rate with the neonatale blood pressure and heart rate
Measured: Prenatal to 1-3 days after birth
To study the association between prenatal air pollution exposure and in utero cardiac remodeling
to evaluate prenatal air pollution (black carbon particles in blood sample mother and placenta) with strain and strain rate
Measured: Prenatal to 1-3 days after birth
To investigate placenta functioning as a mediator between air pollution and cardiac remodeling
To evaluate prenatal air pollution (black carbon particles in blood sample mother and placenta) with placenta insufficiency (biochemical marker, Doppler ultrasound)
Measured: Prenatal to 1-3 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start22 Jun 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RestrictionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Maxima Medical Center, Hasselt University
- Responsible party
- Sponsor
- Investigators
- Kristien Roelens, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423665
- Sponsor's protocol ID
- ONZ-2022-0193
- Acronym
- HEART
- Status last verified
- Sep 2026
- First submitted
- 31 May 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth in Twin Pregnancies
- ClinicalTrials.gov ID
- NCT05423665
- Acronym / sponsor ID
- HEART / ONZ-2022-0193
- Conditions
- Fetal Growth Restriction, Cardiac Remodeling, Ventricular, Placental Insufficiency, Air Pollution
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- KU Leuven, Maxima Medical Center, Hasselt University
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 21 Jun 2022 (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.
In this project there are 2 time points during the pregnancy included, namely at 21 weeks and 30 weeks of gestation, to measure the predictive values of FGR, strain and strain rate. The fetal growth parameters will be collected at the same time points, to define the growth (differences) throughout gestation of both fetuses. A maternal blood sample will be taken at 21 weeks of gestation to identify the level of exposure to air pollution (black carbon) and the level of biochemical markers of placental dysfunction. Doppler ultrasounds will be used for antenatal identification of placenta insufficiency. At birth, umbilical cord blood and the placenta will be collected. The placenta will be examined, to identify morphological findings which are associated with FGR. The umbilical cord blood and placental biopsy will be used for the level of exposure to air pollution and the level of oxidative stress. One to three days after birth, neonatal strain and strain rate will be measured to define postnatal cardiac remodeling as well as the neonatal blood pressure as cardiovascular risk factor.
Detailed description
Fetal growth restriction (FGR) is diagnosed in 5-10% of the pregnancies. After preterm birth, it is the second leading cause of perinatal morbidity and mortality. Twin pregnancies have a higher occurrence of FGR than singletons, in monochorionic (MC) twin pregnancies it's diagnosed in 19.7% of the cases and in dichorionic (DC) twin pregnancies in 10.5% of the cases. Fetuses with FGR are at greater risk of perinatal morbidity and mortality and even long-term health defects. From a public health perspective, it's important to correctly diagnose FGR to adjust the antenatal and postnatal care and to have more insight into the factors influencing early onset cardiovascular disease. STE has a strong predictive value for cardiovascular function, therefore it would be a promising tool to add in the routine pregnancy clinical care. Speckle tracking echocardiography (STE) is a relative new technique especially in the pregnancy follow up, which permits offline calculation of myocardial velocities and deformation parameters. These parameters, including strain and strain rate, provide information about the fetal myocardial function. Apart from investigating if STE can be used for the prediction of FGR, we will also investigate the association between fetal exposure to air pollution and in utero cardiac remodeling. Indeed, it is known that inhalation of particulate matter (e.g. black carbon) during the pregnancy can reach the placenta and lead to alterations in the placenta's function including increases in oxidative stress markers. Early life exposure to black carbon has been associated with adverse cardiovascular health outcomes and reduction of fetal growth, especially in multiple gestation pregnancies.
In this project we will include 2 time points during the pregnancy, namely at 21 weeks and 30 weeks of gestation, to measure the predictive values of FGR, strain and strain rate. The fetal growth parameters will be collected at the same time points, to define the growth (differences) throughout gestation of both fetuses. A maternal blood sample will be taken at 20 weeks of gestation to identify the level of exposure to air pollution (black carbon) and the level of biochemical markers of placental dysfunction. Doppler ultrasounds will be used for antenatal identification of placenta insufficiency. At birth, umbilical cord blood and the placenta will be collected. The placenta will be examined, to identify morphological findings which are associated with FGR. The umbilical cord blood and placental biopsy will be used for the level of exposure to air pollution and the level of oxidative stress. One to three days after birth, neonatal strain and strain rate will be measured to define postnatal cardiac remodeling as well as the neonatal blood pressure as cardiovascular risk factor.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetal growth restricted | – | Other: sample collectionObservation of cardiac remodeling perinatal and postnatal |
| Appropriately grown | – | Other: sample collectionObservation of cardiac remodeling perinatal and postnatal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The number of subjects that will be included in this study is: 600 neonates (200 twin pairs and 200 singletons) and 400 pregnant mothers. The fetuses are divided into following sub-groups: * Appropriately grown * Fetal growth restricted * Selective fetal growth restricted (specific for twins)
Key inclusion criteria (3 listed)
- Singleton or dichorionic twin pregnancy
- Pregnant women 21 weeks ( ± 2 weeks) of gestation at the first visit
- Women ≥ 18 years
Key exclusion criteria (8 listed)
- Women pregnant of multiples of higher order (≥3 siblings) Monochorionic twin pregnancy
- Fetal arrhythmia
- Known fetal congenital or genetic abnormalities
- Any suspicion of congenital fetal anomalies that might influence fetal cardiac function
- Pre-existing maternal hypertensive disease
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 |
|---|---|---|
| sample collectionblood sample at 21 weeks of gestation clips of the fetal heart at 21 weeks of gestation, 30 weeks of gestation and 1-3 days after birth collection of umbilical cord blood at birth collection of the placenta at birth | Other | Appropriately grown, Fetal growth restricted |
Primary outcome
To assess the change in strain measured by speckle tracking echocardiography as a tool for early diagnosis of impaired fetal growth in multiple gestations
Time frame: Prenatal to 1-3 days after birth
to determine the change in fetal strain and strain rate in twin pregnancies in comparison with fetal growth
To determine the intra-pair differences in fetal growth and strain (cardiac remodeling) in multiple gestations.
Time frame: Prenatal to 1-3 days after birth
to compare changes in strain and strain rate with fetal growth within 1 twin pair
To compare the strain values (cardiac remodeling) between singletons and twin pregnancies
Time frame: Prenatal to 1-3 days after birth
to compare the changes in strain and strain rate between singletons and twin pregnancies
4 secondary outcomes
To investigate the association between placenta functioning and in utero cardiac remodeling
Time frame: Prenatal to 1-3 days after birth
To explore in utero cardiac remodeling in association with neonatal cardiovascular health
Time frame: Prenatal to 1-3 days after birth
To study the association between prenatal air pollution exposure and in utero cardiac remodeling
Time frame: Prenatal to 1-3 days after birth
To investigate placenta functioning as a mediator between air pollution and cardiac remodeling
Time frame: Prenatal to 1-3 days after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kristien Roelens principal investigator
University Hospital, Ghent
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Restriction and Cardiac Remodeling, Ventricular, run by University Hospital, Ghent at 3 sites in 2 countries.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eline Meireson (0032 9 332 78 17, eline.meireson@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the change in strain measured by speckle tracking echocardiography as a tool for early diagnosis of impaired fetal growth in multiple gestations (time frame: Prenatal to 1-3 days after birth). The study lists 3 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 21 Sep 2026.