HEART: Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies

Sponsor
University Hospital, Ghent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05423665
Collaborator
KU Leuven (Other), Maxima Medical Center (Other), Hasselt University (Other)
360
67.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: sample collection

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

Study Type:
Observational
Anticipated Enrollment :
360 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth in Twin Pregnancies
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2027
Anticipated Study Completion Date :
Feb 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Fetal growth restricted

Observation of cardiac remodeling perinatal and postnatal

Other: sample collection
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

Appropriately grown

Observation of cardiac remodeling perinatal and postnatal

Other: sample collection
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

Outcome Measures

Primary Outcome Measures

  1. To assess the change in strain measured by speckle tracking echocardiography as a tool for early diagnosis of impaired fetal growth in multiple gestations [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

  2. To determine the intra-pair differences in fetal growth and strain (cardiac remodeling) in multiple gestations. [Prenatal to 1-3 days after birth]

    to compare changes in strain and strain rate with fetal growth within 1 twin pair

  3. To compare the strain values (cardiac remodeling) between singletons and twin pregnancies [Prenatal to 1-3 days after birth]

    to compare the changes in strain and strain rate between singletons and twin pregnancies

Secondary Outcome Measures

  1. To investigate the association between placenta functioning and in utero cardiac remodeling [Prenatal to 1-3 days after birth]

    to evaluate placenta insufficiency (Doppler ultrasound, biochemical marker) with strain and strain rate

  2. To explore in utero cardiac remodeling in association with neonatal cardiovascular health [Prenatal to 1-3 days after birth]

    to evaluate strain and strain rate with the neonatale blood pressure and heart rate

  3. To study the association between prenatal air pollution exposure and in utero cardiac remodeling [Prenatal to 1-3 days after birth]

    to evaluate prenatal air pollution (black carbon particles in blood sample mother and placenta) with strain and strain rate

  4. To investigate placenta functioning as a mediator between air pollution and cardiac remodeling [Prenatal to 1-3 days after birth]

    To evaluate prenatal air pollution (black carbon particles in blood sample mother and placenta) with placenta insufficiency (biochemical marker, Doppler ultrasound)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
  • Singleton or twin pregnancy

  • Pregnant women 21 weeks ( ± 2 weeks) of gestation at the first visit

  • Women ≥ 18 years

Exclusion Criteria:
  • Women pregnant of multiples of higher order (≥3 siblings)

  • 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Ghent
  • KU Leuven
  • Maxima Medical Center
  • Hasselt University

Investigators

  • Principal Investigator: Kristien Roelens, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT05423665
Other Study ID Numbers:
  • ONZ-2022-0193
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022