PreeclampsiaNCT04264247
First Trimester Fetal Thymus Volume May Predict Preeclampsia
An observational study of Preeclampsia, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
The exact etiology of preeclampsia remains unclear but is known to involve immunological 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?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- routine fetal ultrasonography at 11-14 weeks
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 17 Jan 2019
- 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 18 to 35 years
- Women only
- Adult
Study population: 100 pregnancy women at 11-14 week of gestation were included in the study in the Obstetrics Department of Obstetrics and Gynecology of Medicine Faculty of Karadeniz Technical University, Medical Faculty of Medicine.
Who may be able to join
- 11-14 weeks pregnancy with no abnormal ultrasonography evidence.
Who cannot join
- Any history of obstetric complications Chronic hypertension Diabetes mellitus Infectious or autoimmune disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There Any Relationship Between First Trimester (11-14 Weeks of Pregnancy) Fetal Thymus Volume and Preeclampsia? Prospective Cohort Study.
The exact etiology of preeclampsia remains unclear but is known to involve immunological 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 fetal thymus volume on ultrasound and preeclampsia by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 11-14 week of gestation.
Investigators performed a prospective clinical study in 100 pregnant women in their first 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, CRL 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 preeclampsia and without preeclampsia were compared. The ability of the thymus volume to predict the preeclampsia was tested using binary logistic regression analysis. P value <0.05 was considered statistically significant.
Read the detailed description
The exact etiology of preeclampsia remains unclear but is known to involve immunological 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 fetal thymus volume on ultrasound and preeclampsia by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 11-14 week of gestation.
- Conditions
- Preeclampsia
- Being tested
- routine fetal ultrasonography at 11-14 weeks
- Keywords
- Fetal thymus volume, Preeclampsia, Screening, Prediction
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine fetal ultrasonography at 11-14 weeksDiagnostic test
routine fetal ultrasonography at 11-14 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Preeclampsia
Hypertension (Sistolik blood pressure >140, diastolic blood pressure >90), Proteinuria (>0.3 g proteinuria in 24 hour collected urine sample)
Measured: At least after 10 weeks of initial examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Feb 2017
- Primary completion1 Jan 2018
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies 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, Ozlem Ece BASARAN, Karadeniz Technical University
- Investigators
- Ozlem E Basaran, Principal investigator, Karadeniz technical universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264247
- Sponsor's protocol ID
- 2016/176
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mohamed N, Eviston DP, Quinton AE, Benzie RJ, Kirby AC, Peek MJ, Nanan RK. Smaller fetal thymuses in pre-eclampsia: a prospective cross-sectional study. Ultrasound Obstet Gynecol. 2011 Apr;37(4):410-5. doi: 10.1002/uog.8953. Epub 2011 Mar 7.
PubMed 21308839
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There Any Relationship Between First Trimester (11-14 Weeks of Pregnancy) Fetal Thymus Volume and Preeclampsia? Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT04264247
- Acronym / sponsor ID
- 2016/176
- Conditions
- Preeclampsia
- Keywords
- Fetal thymus volume, Preeclampsia, Screening, Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 11 Feb 2020 (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 preeclampsia remains unclear but is known to involve immunological 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 fetal thymus volume on ultrasound and preeclampsia by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 11-14 week of gestation.
Investigators performed a prospective clinical study in 100 pregnant women in their first 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, CRL 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 preeclampsia and without preeclampsia were compared. The ability of the thymus volume to predict the preeclampsia was tested using binary logistic regression analysis. P value <0.05 was considered statistically significant.
Detailed description
The exact etiology of preeclampsia remains unclear but is known to involve immunological 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 fetal thymus volume on ultrasound and preeclampsia by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 11-14 week of gestation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 100 pregnancy women at 11-14 week of gestation were included in the study in the Obstetrics Department of Obstetrics and Gynecology of Medicine Faculty of Karadeniz Technical University, Medical Faculty of Medicine.
Key inclusion criteria (1 listed)
- 11-14 weeks pregnancy with no abnormal ultrasonography evidence.
Key exclusion criteria (1 listed)
- Any history of obstetric complications Chronic hypertension Diabetes mellitus Infectious or autoimmune disease.
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 |
|---|---|---|
| routine fetal ultrasonography at 11-14 weeksroutine fetal ultrasonography at 11-14 weeks | Diagnostic test | – |
Primary outcome
Preeclampsia
Time frame: At least after 10 weeks of initial examination.
Hypertension (Sistolik blood pressure >140, diastolic blood pressure >90), Proteinuria (>0.3 g proteinuria in 24 hour collected urine sample)
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 11 Feb 2020.
- Background: PubMed 21308839Mohamed N, Eviston DP, Quinton AE, Benzie RJ, Kirby AC, Peek MJ, Nanan RK. Smaller fetal thymuses in pre-eclampsia: a prospective cross-sectional study. Ultrasound Obstet Gynecol. 2011 Apr;37(4):410-5. doi: 10.1002/uog.8953. Epub 2011 Mar 7.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
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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.
Ozlem E Basaran principal investigator
Karadeniz technical universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Preeclampsia (time frame: At least after 10 weeks of initial examination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04264247, which also lists 1 linked publication.
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 11 Feb 2020.