Cardiac Displacement From Third Trimester to Early Childhood (CADETTE)

University Hospital, Linkoeping

Status: Active, not recruiting

Conditions: Fetal Growth Retardation; Intrauterine Growth Restriction; IUGR

Treatments: Other: Echocardiography; Procedure: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT02583763

2012/257-31

Details and patient eligibility

About

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.

Full 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 7-9 years of age.

The investigators will take a blood sample from the umbilical cord at birth and again at 7-9 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.

Enrollment: 61 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

61 participants in 2 patient groups

Fetuses/Children with IUGR

Description:

The moving sequences of the heart movement are collected at the regular ultrasound examinations during pregnancy. Following delivery the investigators plan to examine the baby with cardiac ultrasound, echocardiography, between 12 and 72 hours after delivery and again when the child is 3-4 months old and at 9 years of age. Blood sample will be taken from the umbilical cord at birth and again at 9 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 children's DNA. Due to corona pandemic the follow up was delayed from 7 to 9 years of age. Approved by the ethical committee.

Treatment:

Procedure: Blood sample

Other: Echocardiography

Healthy Controls

Description:

The moving sequences of the heart movement are collected at two occasions approximately 4 weeks apart. This takes place during gestational weeks 28-36. Following delivery the investigators plan to examine the baby with cardiac ultrasound, echocardiography, between 12 and 72 hours after delivery and again when the child is 3-4 months old and at 9 years of age. Blood sample will be taken from the umbilical cord at birth and again at 9 years of age. The investigators will analyze the blood for growth factors and cardiac markers. An additional ethical approval was accepted 2015 for analysing epigenetic factors in the children's DNA. Due to corona pandemic the follow up was delayed from 7 to 9 years of age. Approved by the ethical committee.

Treatment:

Procedure: Blood sample

Other: Echocardiography