Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05423665
Other study ID # ONZ-2022-0193
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 22, 2023
Est. completion date February 1, 2028

Study information

Verified date September 2023
Source University Hospital, Ghent
Contact Eline Meireson
Phone 0032 9 332 78 17
Email eline.meireson@uzgent.be
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date February 1, 2028
Est. primary completion date February 1, 2027
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Singleton or dichorionic 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) 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)

Study Design


Intervention

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

Locations

Country Name City State
Belgium Ghent University Hospital Ghent
Belgium Universitair ziekenhuis Leuven Leuven
Netherlands Maxima medical center Eindhoven

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Ghent Hasselt University, KU Leuven, Maxima Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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 Prenatal to 1-3 days after birth
Secondary 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 Prenatal to 1-3 days after birth
Secondary 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 Prenatal to 1-3 days after birth
Secondary 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) Prenatal to 1-3 days after birth
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Recruiting NCT05601375 - Speckle Tracking Echocardiography in Infants, Prenatally and Postnatally
Recruiting NCT03662178 - Investigating the Structured Use of Ultrasound Scanning for Fetal Growth
Completed NCT05059093 - Developing and Testing AI Models for Fetal Biometry and Amniotic Volume Assessment in Fetal Ultrasound Scans.
Completed NCT03067298 - Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
Recruiting NCT01981824 - Prediction of Growth Restricted Fetuses Using Femur Length to Mid-thigh Circumference Ratio: A Case-control Study N/A
Recruiting NCT04215107 - Fetal Distribution of Feto-placental Blood Flow Related to Placental Nutrient Transport and Maternal Food Intake N/A
Completed NCT02189148 - First-trimester Prediction of Preeclampsia
Terminated NCT04084990 - Sleep Apnea and Fetal Growth Restriction Phase 3
Recruiting NCT04051567 - Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies Phase 4
Recruiting NCT04394611 - Metals and in Fetal Growth Restriction
Completed NCT01369940 - The NICHD Fetal Growth Study: Twin Gestations N/A
Not yet recruiting NCT03121196 - Social Deprivation and Pregnancy N/A
Recruiting NCT03177824 - Sildenafil Citrate for Treatment of Growth-restricted Fetuses Phase 3
Completed NCT02379832 - Pre-Eclampsia And Growth Restriction: a Longitudinal Study
Completed NCT02379494 - First Trimester Prediction of Preeclampsia and Fetal Growth Restriction N/A
Completed NCT03046355 - Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women N/A
Not yet recruiting NCT05848869 - Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction N/A
Recruiting NCT04438668 - Evaluation of the Safety and Performance of Centaflow N/A
Not yet recruiting NCT06343051 - USCOM in Newly Diagnosed FGR Cases