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| Name | Class |
|---|---|
| Ostergotland County Council, Sweden | OTHER |
| Stiftelsen Samariten | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fetuses/Children with IUGR | 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. |
| |
| Healthy Controls | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Velocity of the Cardiac Walls cm/s Divided With Chamber Length in mm = Quota cm/s / mm | Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions. At each timepoint offline calculation were performed three times on each image and an averaged was calculated. The length of the heart from the level of the AV valve to the apex in left ventricle is used as a measurement for the size of the heart. As the velocity increases when the size of the heart increases a quota is used dividing the velocity by the length of the heart to be able to compare the velocity at different timepoints whe the child is growing. Quota=Left chamber velocity at septum stated in cm/s divided by ventricular length in mm. | After delivery echocardiography were performed. This is one time point. Due to the known dramatic hemodynamic changes for all children right after birth we defined this time point to somewhere between 12 and 72 hours of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Chamber Longitudinal Displacement in the Septal Wall at the AV Valve Level Corrected for Ventricular Length Expressed as a Ratio. | Echocardiography images of the heart's walls are outlined and the software extracts the movement in mm in the myocardial wall from end diastole to end systole. The movement of the myocardium from end diastole to end systole at the AV valve level of the septal wall is measured in mm and expressed as a ratio compared to the ventricular length in mm at the end of diastole. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Olov Änghagen, PhD student | Dept of Paediatric, Linköping | Principal Investigator |
| Nina Nelson, Professor | Karolinska University Hospital, Stockholm | Study Chair |
| Peter Bang, Professor | Dept of Paediatric, Linköping | Study Chair |
| Jan Engvall, Professor | Dept of Clinical Physiology, Linköping | Study Chair |
| Eva Nylander, Professor | Dept of Clinical Physiology, Linköping | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Obstetrics and Gynecology | Linköping | 58185 | Sweden | |||
| Paediatric Department University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35333947 | Derived | Anghagen O, Engvall J, Gottvall T, Nelson N, Nylander E, Bang P. Developmental Differences in Left Ventricular Strain in IUGR vs. Control Children the First Three Months of Life. Pediatr Cardiol. 2022 Aug;43(6):1286-1297. doi: 10.1007/s00246-022-02850-y. Epub 2022 Mar 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fetuses/Children With IUGR | 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 7 years of age. Blood sample will be taken 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 children's DNA. 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. Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age. |
| FG001 | Healthy Controls | 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 7 years of age. Blood sample will be taken from the umbilical cord at birth and again at 7 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. 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. Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fetuses/Children With IUGR | 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 7 years of age. Blood sample will be taken 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 children's DNA. 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. Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Velocity of the Cardiac Walls cm/s Divided With Chamber Length in mm = Quota cm/s / mm | Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions. At each timepoint offline calculation were performed three times on each image and an averaged was calculated. The length of the heart from the level of the AV valve to the apex in left ventricle is used as a measurement for the size of the heart. As the velocity increases when the size of the heart increases a quota is used dividing the velocity by the length of the heart to be able to compare the velocity at different timepoints whe the child is growing. Quota=Left chamber velocity at septum stated in cm/s divided by ventricular length in mm. | Posted | Mean | Standard Deviation | cm/s/mm = quota | After delivery echocardiography were performed. This is one time point. Due to the known dramatic hemodynamic changes for all children right after birth we defined this time point to somewhere between 12 and 72 hours of age. |
|
Time frame from inclusion to 9 years of age with 3 specific timepoints of follow-ups. at 12-72 hours of age. at 3- 4 months of age at 9 years of age.
As this is an observational study we do not introduce any extra risk for the children when participating in the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fetuses/Children With IUGR | 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 7 years of age. Blood sample will be taken 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 children's DNA. 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. Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olov Änghagen PhD student | Region Östergötland / University of Linköping | +461047246 | olov.anghagen@regionostergotland.se |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2014 | Feb 16, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The investigators will take a blood sample from the umbilical cord at birth and again at 9 years of age. The sample will be analyzed for growth factors and cardiac markers.
2015-05-20 an additional ethical approval was accepted for analyzing epigenetic factors in the children's DNA.
| Blood sample | Procedure | The investigators will take a blood sample from the umbilical cord at birth and again at 9 years of age. |
|
| After delivery echocardiography were performed. This is one time point. Due to the known dramatic hemodynamic changes for all children right after birth we defined this time point to somewhere between 12 and 72 hours of age. |
| Average Longitudinal 4 Segmental Strain in the Cardiac Wall. Shortening of the Myocardium in Systole. | Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions. A 4 chamber view of the hartt is used and calculation of 6 segments (2 basal, 2 mid and 2 apical segments) were performed three times on each image and an averaged was calculated. The 2 basal segments closeset to the AV valve and the two 2 mid segments were summed and averaged into average longitudinal 4 segmental strain. Strain in % is the averege shortening of the myocardium in systole. | At 3 months |
| Cardiac Marker Troponin T | Comparing cardiac marker troponin T between the two groups | At birth and at 9 years of age |
| Cardiac Marker N-terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP) | Comparing N-terminal prohormone of brain natriuretic peptide marker NT-ProBNP between the two groups | At birth and at 9 years of age |
| Insulin-like Growth Factor-1 (IGF-1) | Comparing IGF-1 between the two groups | At birth and at 9 years of age |
| Insulin-like Growth Factor Binding Protein (IGFBP) | Comparing Insulin-like growth factor binding protein (IGFBP) between the two groups | At birth and at 9years of age |
| DNA Methylation and Gene Expression in Blood Monocytes and Lymphocytes | Changes in DNA methylation and gene expression will be compared between the two groups | At birth and at 9 years of age |
| Linköping |
| 59071 |
| Sweden |
| BG001 | Healthy Controls | 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 7 years of age. Blood sample will be taken from the umbilical cord at birth and again at 7 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. 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. Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age. |
| BG002 | Total | Total of all reporting groups |
| Gestational age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Growth restriction was defined as a prenatal estimated weight deviation more than 22% from the normal curve at a given gestational age or growth rate deviating more than 10% compared to the previous measurement in relation to the expected weight. |
| OG001 | Healthy Controls | Fetuses in a control group were randomly selected among pregnant women who came for routine ultrasound during pregnancy at gestational week 18-20 having normal fetal examination with a normal estimated birth weight. |
|
|
|
| Secondary | Left Chamber Longitudinal Displacement in the Septal Wall at the AV Valve Level Corrected for Ventricular Length Expressed as a Ratio. | Echocardiography images of the heart's walls are outlined and the software extracts the movement in mm in the myocardial wall from end diastole to end systole. The movement of the myocardium from end diastole to end systole at the AV valve level of the septal wall is measured in mm and expressed as a ratio compared to the ventricular length in mm at the end of diastole. | Posted | Mean | Standard Deviation | mm/mm = ratio | After delivery echocardiography were performed. This is one time point. Due to the known dramatic hemodynamic changes for all children right after birth we defined this time point to somewhere between 12 and 72 hours of age. |
|
|
|
|
| Secondary | Average Longitudinal 4 Segmental Strain in the Cardiac Wall. Shortening of the Myocardium in Systole. | Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions. A 4 chamber view of the hartt is used and calculation of 6 segments (2 basal, 2 mid and 2 apical segments) were performed three times on each image and an averaged was calculated. The 2 basal segments closeset to the AV valve and the two 2 mid segments were summed and averaged into average longitudinal 4 segmental strain. Strain in % is the averege shortening of the myocardium in systole. | Average longitudinal 4 segmental myocardial strain at 3 months of age | Posted | Mean | Standard Deviation | percentage of myocardium shortening. | At 3 months |
|
|
|
|
| Secondary | Cardiac Marker Troponin T | Comparing cardiac marker troponin T between the two groups | Not Posted | Dec 2028 | At birth and at 9 years of age | Participants |
| Secondary | Cardiac Marker N-terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP) | Comparing N-terminal prohormone of brain natriuretic peptide marker NT-ProBNP between the two groups | Not Posted | Dec 2028 | At birth and at 9 years of age | Participants |
| Secondary | Insulin-like Growth Factor-1 (IGF-1) | Comparing IGF-1 between the two groups | Not Posted | Dec 2028 | At birth and at 9 years of age | Participants |
| Secondary | Insulin-like Growth Factor Binding Protein (IGFBP) | Comparing Insulin-like growth factor binding protein (IGFBP) between the two groups | Not Posted | Dec 2028 | At birth and at 9years of age | Participants |
| Secondary | DNA Methylation and Gene Expression in Blood Monocytes and Lymphocytes | Changes in DNA methylation and gene expression will be compared between the two groups | Not Posted | Dec 2028 | At birth and at 9 years of age | Participants |
| 2 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Healthy Controls | 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 7 years of age. Blood sample will be taken from the umbilical cord at birth and again at 7 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. 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. Blood sample: The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |