Intrauterine Growth RestrictionIUGRNCT05328453
Sonographic 3D Measurement of Fetal Thymus May be Used to Predict the Small Baby in Pregnancy.
An observational study of Intrauterine Growth Restriction, run by Karadeniz Technical University.
Trial summary
The exact etiology of intrauterine growth restriction (IUGR) remains unclear but is known to involve immunologic/infectious factors. The thymus is one of the main organs involved in the development of the fetal immune system. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Intrauterine Growth Restriction
- What is being tested?
- Fetal prenatal ultrasonographic evaluation.
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Study population: This prospective cohort study included 100 women with a single pregnancy who presented at the current clinic in one year period and had no risk factors for high-risk pregnancy in the second trimester screening for anomalies.
Who may be able to join
- Aged 18-35 years,
- Who presented at the polyclinic for routine antenatal follow-up at 15-24 weeks
- Had no complaints.
- Had normal renal, hepatic, and thyroid functions test results.
Who cannot join
- Any known endocrinopathy,
- systemic disease,
- collagen disorder,
- hypercholesterolemia,
- hemoglobinopathy
- history of neoplasm,
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- current or previous cardiovascular disease,
- the use of any drugs within the 3 months before the pregnancy,
- multiple pregnancy,
- current smoking,
- abnormal renal, hepatic, or thyroid function test results,
- the presence of any findings of fetal chromasomal or structural anomaly,
- refusal to participate in the study.
About this study
Official title: Prenatal Sonographic 3D VOCAL Thymic Volume Calculation May Predict Intrauterine Growth Restriction
The exact etiology of intrauterine growth restriction (IUGR) remains unclear but is known to involve immunologic/infectious factors. The thymus is one of the main organs involved in the development of the fetal immune system. The aim of this study was to explore the association between 3D fetal thymus volume (VOCAL) on ultrasound and intrauterine growth restiction by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 15-24 week of gestation.
Investigators performed a prospective clinical study in 100 pregnant women in their second trimester of pregnancy who attended the Fetal Medicine Unit of the Medicine Faculty of Karadeniz Technical University during the study period. Maternal age, gravida, para, BMI, blood pressure, gestational age, BPD, FL ,AC, EFW and fetal timus volume measured with VOCAL programme are recorded. For all patients routine clinical and ultrasound examinations were performed during pregnancy. Gestational age at birth, way of birth and newborn birthweight were recorded. The results were statistically compared in the SPSS 13.0 program. Student-t test and chi-square test were used for statistical analysis. ROC curve analysis was used for limit values. The data of patients with IUGR and without IUGR were compared. The ability of the thymus volume to predict the IUGR was tested using binary logistic regression analysis. P value <0.05 was considered statistically significant.
Read the detailed description
A signed informed consent form for voluntary participation in the study was provided by all the women. A record was made for each patient of age, gravida, parity, body mass index (BMI), and sonographic measurements of biparietal diameter (BPD), abdominal circumference (AC), femur length (FL), and estimated fetal weight (EFW).
3D Fetal thymus volume (TV) was measured by using a VOLUSON E-10 ultrasonography device, by a single researcher experienced in the use of obstetric ultrasound with a transabdominal volumetric probe. The fetal thymus, transverse section of the fetal chest, and the 3 vessel sections were visualised, then the 3D US modality was activated and the thymus volume was obtained immediately with the same probe.
All cases were followed up in terms of pregnancy complications (IUGR development) until delivery.
- Conditions
- Intrauterine Growth Restriction
- Being tested
- Fetal prenatal ultrasonographic evaluation.
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal prenatal ultrasonographic evaluation.Diagnostic test
Routine fetal ultrasonography at 15-24 weeks. All sonographic measurements including 3D fetal thymus calculation was measured.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women at 15-24 gestation. | Routine fetal ultrasonography at 15-24 weeks. All sonographic measurements including 3D fetal thymus calculation was measured. Receives: Diagnostic Test: Fetal prenatal ultrasonographic evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IUGR development.
IUGR was accepted as EFW below the 10th percentile according to BPD, FL, and AC
Measured: One year period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Mar 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Guven, Karadeniz Technical University
- Investigators
- Suleyman Guven, Prof, Study chair, Karadeniz Technical University Faculty of Medicine Department of Obs and Gyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328453
- Sponsor's protocol ID
- 2016/181
- Acronym
- IUGR
- Status last verified
- Apr 2022
- First submitted
- 10 Feb 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Sonographic 3D VOCAL Thymic Volume Calculation May Predict Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT05328453
- Acronym / sponsor ID
- IUGR / 2016/181
- Conditions
- Intrauterine Growth Restriction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The exact etiology of intrauterine growth restriction (IUGR) remains unclear but is known to involve immunologic/infectious factors. The thymus is one of the main organs involved in the development of the fetal immune system. The aim of this study was to explore the association between 3D fetal thymus volume (VOCAL) on ultrasound and intrauterine growth restiction by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 15-24 week of gestation.
Investigators performed a prospective clinical study in 100 pregnant women in their second trimester of pregnancy who attended the Fetal Medicine Unit of the Medicine Faculty of Karadeniz Technical University during the study period. Maternal age, gravida, para, BMI, blood pressure, gestational age, BPD, FL ,AC, EFW and fetal timus volume measured with VOCAL programme are recorded. For all patients routine clinical and ultrasound examinations were performed during pregnancy. Gestational age at birth, way of birth and newborn birthweight were recorded. The results were statistically compared in the SPSS 13.0 program. Student-t test and chi-square test were used for statistical analysis. ROC curve analysis was used for limit values. The data of patients with IUGR and without IUGR were compared. The ability of the thymus volume to predict the IUGR was tested using binary logistic regression analysis. P value <0.05 was considered statistically significant.
Detailed description
A signed informed consent form for voluntary participation in the study was provided by all the women. A record was made for each patient of age, gravida, parity, body mass index (BMI), and sonographic measurements of biparietal diameter (BPD), abdominal circumference (AC), femur length (FL), and estimated fetal weight (EFW).
3D Fetal thymus volume (TV) was measured by using a VOLUSON E-10 ultrasonography device, by a single researcher experienced in the use of obstetric ultrasound with a transabdominal volumetric probe. The fetal thymus, transverse section of the fetal chest, and the 3 vessel sections were visualised, then the 3D US modality was activated and the thymus volume was obtained immediately with the same probe.
All cases were followed up in terms of pregnancy complications (IUGR development) until delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women at 15-24 gestation. | – | Diagnostic Test: Fetal prenatal ultrasonographic evaluation.Routine fetal ultrasonography at 15-24 weeks. All sonographic measurements including 3D fetal thymus calculation was measured. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- This prospective cohort study included 100 women with a single pregnancy who presented at the current clinic in one year period and had no risk factors for high-risk pregnancy in the second trimester screening for anomalies.
Key inclusion criteria (4 listed)
- Aged 18-35 years,
- Who presented at the polyclinic for routine antenatal follow-up at 15-24 weeks
- Had no complaints.
- Had normal renal, hepatic, and thyroid functions test results.
Key exclusion criteria (13 listed)
- Any known endocrinopathy,
- systemic disease,
- collagen disorder,
- hypercholesterolemia,
- hemoglobinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal prenatal ultrasonographic evaluation.Routine fetal ultrasonography at 15-24 weeks. All sonographic measurements including 3D fetal thymus calculation was measured. | Diagnostic test | Pregnant women at 15-24 gestation. |
Primary outcome
IUGR development.
Time frame: One year period.
IUGR was accepted as EFW below the 10th percentile according to BPD, FL, and AC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suleyman Guven, Prof study chair
Karadeniz Technical University Faculty of Medicine Department of Obs and Gyn
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction, run by Karadeniz Technical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IUGR development. (time frame: One year period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.