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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity Hospital, Ghent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Singleton or dichorionic twin pregnancy

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

Women ≥ 18 years

Disqualifiers

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

Trial 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)

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • sample collection

    Other intervention

    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

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Fetal growth restricted1 intervention
Group B: Appropriately grown1 intervention

Trial outcomes

Primary outcomes

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

to determine the change in fetal strain and strain rate in twin pregnancies in comparison with fetal growth

Time frame
Prenatal to 1-3 days after birth
2

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

Time frame
Prenatal to 1-3 days after birth
3

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

Time frame
Prenatal to 1-3 days after birth

Secondary outcomes

1

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

Time frame
Prenatal to 1-3 days after birth
2

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

Time frame
Prenatal to 1-3 days after birth
3

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

Time frame
Prenatal to 1-3 days after birth
4

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)

Time frame
Prenatal to 1-3 days after birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

KU Leuven

Collaborator

Maxima Medical Center

Collaborator

Hasselt University

Collaborator