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CompletedNCT04264247Updated Feb 11, 2020

First Trimester Fetal Thymus Volume May Predict Preeclampsia

An observational study in Preeclampsia, sponsored by Karadeniz Technical University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by Karadeniz Technical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 35 Years
Sex
Female
01

Study 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. 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.

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Conditions studied

  • Preeclampsia

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Keywords

  • Fetal thymus volume
  • Preeclampsia
  • Screening
  • Prediction
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In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 100 is below the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Karadeniz Technical University is the lead sponsor of 145 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Sampling method
Probability sample

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.

Inclusion criteria

  • 11-14 weeks pregnancy with no abnormal ultrasonography evidence.

Exclusion criteria

Exclusion Criteria:

Any history of obstetric complications Chronic hypertension Diabetes mellitus Infectious or autoimmune disease.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testroutine fetal ultrasonography at 11-14 weeks

    routine fetal ultrasonography at 11-14 weeks

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What researchers measure

Primary outcomes

  1. Preeclampsia

    Hypertension (Sistolik blood pressure \>140, diastolic blood pressure \>90), Proteinuria (\>0.3 g proteinuria in 24 hour collected urine sample)

    Time frame: At least after 10 weeks of initial examination.

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Study locations

1 site
  • Karadeniz Technical University
    Trabzon, 61080, Turkey
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04264247
Lead sponsor
Karadeniz Technical University
Responsible party
Ozlem Ece BASARAN (research assistant, Karadeniz Technical University) — Principal investigator
First posted
Feb 11, 2020
Start date
Feb 1, 2017
Primary completion
Jan 1, 2018
Completion
Jan 17, 2019
Last update
Feb 11, 2020

Study contacts

Ozlem E Basaran
principal investigator · Karadeniz technical universty

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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