Actively Recruiting
Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth in Twin Pregnancies
Led by University Hospital, Ghent · Updated on 2023-09-26
360
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate speckle tracking echocardiography (STE) as a tool for early diagnosis of impaired fetal growth in twin pregnancies. Fetal growth restriction (FGR) occurs more frequently in twin pregnancies compared to singletons and is linked to higher risks of perinatal complications and long-term health issues. The study also investigates the relationship between fetal exposure to air pollution, placental function, and in utero cardiac remodeling. Participants will be observed at two key stages of pregnancy, around 21 and 30 weeks of gestation, where fetal growth parameters and cardiac strain are measured using STE. Maternal blood samples are collected at 21 weeks to assess exposure to air pollution and biochemical markers related to placental dysfunction. Doppler ultrasounds will identify placental insufficiency. At birth, umbilical cord blood and placental tissue are collected for further analysis of pollution exposure and oxidative stress. Neonatal cardiac strain and blood pressure are evaluated 1 to 3 days after birth to assess postnatal cardiac remodeling and cardiovascular risk. Throughout the study, researchers gather detailed data including fetal heart measurements, maternal blood markers, placental examination, and neonatal cardiovascular assessments. The primary outcomes focus on changes in cardiac strain and fetal growth differences, while secondary outcomes explore the links between placental function, air pollution exposure, and cardiac remodeling. The total participant involvement spans from mid-pregnancy through the early neonatal period, with multiple assessments to understand fetal and neonatal cardiovascular health.
CONDITIONS
Brief Title
Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton or dichorionic twin pregnancy
- Pregnant women at approximately 21 weeks (± 2 weeks) of gestation at the first visit
- Women aged 18 years or older
You will not qualify if you...
- Pregnant with triplets or higher order multiples (3 or more siblings)
- Monochorionic twin pregnancy
- Fetal arrhythmia
- Known fetal congenital or genetic abnormalities
- Suspicion of congenital fetal anomalies affecting heart function
- Pre-existing maternal hypertensive disease
- Autoimmune diseases including systemic lupus erythematosus
- History of stillbirth
- Maternal diabetes mellitus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately from 20 to 30 weeks of gestation
Participants undergo fetal ultrasound assessments and maternal blood sampling to evaluate fetal growth and exposure to air pollution.
2 visits (at about 21 and 30 weeks of gestation) plus 1 blood sample collection at 20 weeks
Duration - At delivery and within 1 to 3 days after birth
At birth, umbilical cord blood and the placenta are collected for analysis of exposure to air pollution and placental function.
1 visit at birth and 1 assessment 1 to 3 days after birth
Duration - 1 to 3 days after birth
Participants undergo neonatal cardiac assessments to evaluate postnatal cardiac remodeling and cardiovascular risk factors.
1 visit (in-person) for neonatal strain and blood pressure measurement
Trial Site Locations
Total: 3 locations
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
2
Universitair ziekenhuis Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
3
Maxima medical center
Eindhoven, Netherlands, 5631
Not Yet Recruiting
Research Team
E
Eline Meireson
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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