Cardiac Displacement From Third Trimester to Early Childhood

Fetal Growth Retardation Clinical Trial

— CADETTE  

Official title:

Cardiac Displacement From Third Trimester to Early Childhood

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02583763
• Other study ID #: 2012/257-31
• Status: Active, not recruiting
• Start date: January 2013
• Est. completion date: December 2023

Study information

• Verified date: March 2021
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim is to increase awareness of the relationship between (IUGR) and cardiac function in the foetus, the development of cardiac function over time after delivery and what significance a possible early disturbed myocardial function have for the neonate and the child during the first years of life.

Description:

This is a prospective case-control study in which fetuses from normal pregnancies will be compared with fetuses with IUGR. Parents will be asked to participate in the study in connection with the routine ultrasound examinations at the department of obstetrics to where they have been referred because of suspected IUGR. The control group will be randomly selected among pregnant women who come for routine ultrasound during pregnancy at gestational week 18-20.

Surveys will be performed in the third trimester and after delivery. During the ultrasound examinations standardized, moving sequences of the heart will be saved. Analyses will be performed off-line and analysed by vector velocity imaging software. With this technique, the investigator can quantify the chamber wall and myocardial movements. Speed (velocity), movement (displacement) and thickening/deformation (strain and strain rate) will be recorded in a structured and standardized manner.

When performing the analysis the heart's walls are outlined and the software extracts the movement in different directions.

Data will be obtained concerning the participating mothers previous illness, mothers' age, maternal smoking, BMI, any abnormalities during pregnancy, number of previous pregnancies. Other data that will be recorded are means of delivery and any abnormalities during previous pregnancies, such as hypertension, preeclampsia and pre-natal steroid treatment.

Additional data to be collected from the participating fetuses are flow profiles in the umbilical artery, ductus venosus and middle cerebral artery. Abdominal circumference and estimated weight will be registered.

Following delivery, the participating child's height, weight, head circumference and gestational age at birth are registered. Additional data that will be collected after delivery are umbilical vein and umbilical artery acid base values, Apgar score. If admitted to the pediatric ward the investigators will register the number of days hospitalized in the ward for post-natal care and diagnosis. The investigators plan to examine the participating baby with cardiac ultrasound between 12 and 72 hours after delivery and again when the participating child is 3-4 months old and at 7 years of age.

The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age. The investigators will analyse the blood for growth factors and cardiac markers. An additional ethical approval was accepted 2015 for analysing epigenetic factors in the participating children's DNA.

Based on power calculation the investigators plan to examine between 20-30 fetuses with IUGR and 40-60 healthy fetuses in the control group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Inclusion of research subjects: Growth restriction in routine pregnancy ultrasound, verified by specialist control. Gestational age based on Crown Rump Length measurements during the first trimester. Growth restriction defined by a deviation more than 22% from the normal curve at a given gestational age or growth rate deviates more than 10% compared to the previous measurement in relation to the expected weight.

• Inclusion of controls: Control individuals recruited among mothers who come to routine pregnancy ultrasound control at gestational week 18. These are randomly selected and then asked to participate.

Exclusion Criteria:

• Exclusion of both the cases with IUGR and the control cases are major malformations, twin pregnancy, signs of intrauterine infection during pregnancy, significant illness or significant medical treatment of the mother.

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction
• IUGR

Intervention

Other:
• Echocardiography
During the ultrasound examinations standardized, moving sequences of the heart will be saved. Analyzes are performed off-line and analyzed by vector velocity imaging software.

Procedure:
• Blood sample
The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age.

Locations

Country	Name	City	State
Sweden	Dept of Obstetrics and Gynecology	Linköping
Sweden	Paediatric Department University Hospital	Linköping

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Ostergotland County Council, Sweden, Stiftelsen Samariten

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Velocity of the cardiac walls	Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions.	At least two times before delivery from gestational age 28 weeks to delivery. Three times after delivery, 12-72 hours, 3-4 months and 7 years.
Secondary	Displacement of the cardiac walls	Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions.	At least two times before delivery from gestational age 28 weeks to delivery. Three times after delivery, 12-72 hours, 3-4 months and 7 years.
Secondary	Strain in the cardiac walls	Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions.	At least two times before delivery from gestational age 28 weeks to delivery. Three times after delivery, 12-72 hours, 3-4 months and 7 years.
Secondary	Cardiac marker Troponin T	Comparing cardiac marker troponin T between the two groups	At birth and at 7 years of age
Secondary	Cardiac marker N-terminal prohormone of brain natriuretic peptide (NT-ProBNP)	Comparing cardiac marker NT-ProBNP between the two groups	At birth and at 7 years of age
Secondary	Insulin-like growth factor-1 (IGF-1)	Comparing IGF-1 between the two groups	At birth and at 7 years of age
Secondary	Insulin-like growth factor binding protein (IGFBP)	Comparing IGFBP between the two groups	At birth and at 7 years of age
Secondary	DNA methylation and gene expression in blood monocytes and lumfocytes	Changes in DNA metylation will be compared between the two groups	At birth and at 7 years of age