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

NCT05423665 | Recruiting

• 1 other identifier: ONZ-2022-0193
• Study Type: observational
• Target: 360
• Locations: 2 countries
• Sites: 3

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.

Conditions

Fetal Growth Restriction; Cardiac Remodeling, Ventricular; Placental Insufficiency; Air Pollution

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Prenatal to 1-3 days after birth

Secondary Outcomes (4)

• To investigate the association between placenta functioning and in utero cardiac remodeling

  Prenatal to 1-3 days after birth

• To explore in utero cardiac remodeling in association with neonatal cardiovascular health

  Prenatal to 1-3 days after birth

• To study the association between prenatal air pollution exposure and in utero cardiac remodeling

  Prenatal to 1-3 days after birth

• To investigate placenta functioning as a mediator between air pollution and cardiac remodeling

  Prenatal to 1-3 days after birth

Study Arms (2)

Fetal growth restricted

Observation of cardiac remodeling perinatal and postnatal

Other: sample collection

Appropriately grown

Observation of cardiac remodeling perinatal and postnatal

Other: sample collection

Interventions

sample collection OTHER

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; Fetal growth restricted

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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)

You may qualify if:

• Singleton or dichorionic twin pregnancy
• Pregnant women 21 weeks ( ± 2 weeks) of gestation at the first visit
• Women ≥ 18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• KU Leuven: collaborator
• Maxima Medical Center: collaborator
• Hasselt University: collaborator

Study Sites (3)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

Universitair ziekenhuis Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Maxima medical center

Eindhoven, 5631, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation; Ventricular Remodeling; Placental Insufficiency

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Placenta Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Kristien Roelens

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eline Meireson

CONTACT

0032 9 332 78 17; eline.meireson@uzgent.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 21, 2022
• Study Start: June 22, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

BE (2); NL (1)