- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02017080
Fetal Thyroid Ultrasound And Fetal Thyroid Hormones
Efficacy Of Non Invasive Diagnostic Procedures In Evaluating The Influence Of Maternal Autoimmune Thyroid Gland Disease On Fetus
Study Overview
Status
Detailed Description
Autoimmune thyroid disease complicates 5-20% unselected pregnancies. The crucial impacting factor on the pregnancy outcomes in mothers with autoimmune thyroid disease is the thyroxine level changes.
But, fetal hypo or hyperthyroidism can be found in treated pregnant women with autoimmune thyroid disease, even when their thyroid hormones are in normal range, because thyroid antibodies, antithyroid drugs and iodine pass the placenta.
Our previous results show that high fetal free thyroxine (fT4) levels measured by cordocentesis are unexpectedly frequent in women with autoimmune thyroid disease, including maternal autoimmune hypo- and hyperthyroidism. Increasing awareness that even some mild fetal disorder can have an impact on later neurophysiologic development and the health of an individual makes the recognition and therapy of fetal hypo- or hyperthyroidism an increasingly significant domain of interest. According to our results, fetal fT4 concentrations did not correlate neither with dose of medication nor with ultrasound biometric parameters; the range for maternal thyroid-stimulating hormone (TSH) correlated predominantly with normal fT4 can not be marked off. The type and concentration of antithyroid antibodies might have some prognostic value.
There is a growing list of publications referring to the ultrasound measurement of the fetal thyroid as an important tool for detecting fetal thyroid dysfunction. Fetal thyroid measurement became a part of the clinical guidelines for pregnancies complicated with maternal thyroid disease.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Svetlana S Spremovic- Radjenovic, MD PhD
- Phone Number: +38163696246
- Email: spremovics@gmail.com
Study Contact Backup
- Name: Aleksandra M Gudovic, MD PhD
- Phone Number: +381641642631
- Email: sasagudovic@gmail.com
Study Locations
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Belgrade, Serbia, 11000
- Recruiting
- Clinic for Gynecology and Obstetrics , Clinical Center of Serbia
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Contact:
- Svetlana S Spremovic-Radjenovic, MD PhD
- Phone Number: +38163 696246
- Email: spremovics@gmail.com
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Contact:
- Aleksandra M Gudovic, MD PhD
- Phone Number: +381 64 164 2631
- Email: sasagudovic@gmail.com
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Sub-Investigator:
- Aleksandra M Gudovic, MD PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women diagnosed and treated for autoimmune hyper or hypothyroidism: - Disease diagnosed by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination.
- All of the hyper or hypothyroid women have to be positive for one or both thyroid antibodies when entering the study.
- Patients with autoimmune thyroid disease will be included into the study in the first half of pregnancy, but not later than 20th weeks of gestation
- For the pregnant women in control group:
- if they are euthyroid, with antithyroid antibodies within reference range, healthy and have uncomplicated pregnancy
Exclusion Criteria:
- Patients with chronic diseases (except for thyroid disease) in their past medical history record. Pregnancy induced diseases are not a part of the exclusion criteria (gestational diabetes and pregnancy induced hypertension)
- all the patients whose pregnancies resulted from assisted reproductive technologies will be excluded from the study.
- mothers from the control group will be excluded, if the neonate have abnormal thyroid function
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hyperthyroid pregnant women
Autoimmune hyperthyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound clinical examination
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Hypothyroid pregnant women
Autoimmune hypothyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination
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Healthy pregnant women
Euthyroid women with uncomplicated pregnancies, with antithyroid antibodies within reference ranges
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fetal thyroid size measured by ultrasonography
Time Frame: 28th week of gestation
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28th week of gestation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fetal fT4
Time Frame: 28th week of gestation
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Sampled at the same time when fetal thyroid measurement is done
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28th week of gestation
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Fetal antithyroid antibodies
Time Frame: 28th week of gestation
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Fetal antithyroid antibodies: thyroid peroxidase (TPO), TSH receptor (TRAK), thyroglobuline (Tg) antibodies, will be measure in the same sample as fetal fT4
|
28th week of gestation
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Maternal fT4
Time Frame: 28th week of gestation
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Sampled at the same time as the fetal free thyroxin and fetal antithyroid antibodies
|
28th week of gestation
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Maternal TSH
Time Frame: 28th week of gestation
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Measured in the same sample as maternal fT4
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28th week of gestation
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Maternal antithyroid antibodies
Time Frame: 28th week of gestation
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Measured in the same sample as maternal fT4 Maternal antithyroid antibodies: thyroid peroxidase (TPO), TSH receptor (TRAK), thyroglobuline (Tg) antibodies, will be measured in the same sample as fetal fT4
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28th week of gestation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Svetlana S Spremovic- Radjenovic, MD PhD, Medical School of the University of Belgrade
Publications and helpful links
General Publications
- Achiron R, Rotstein Z, Lipitz S, Karasik A, Seidman DS. The development of the foetal thyroid: in utero ultrasonographic measurements. Clin Endocrinol (Oxf). 1998 Mar;48(3):259-64. doi: 10.1046/j.1365-2265.1998.00388.x.
- Ranzini AC, Ananth CV, Smulian JC, Kung M, Limbachia A, Vintzileos AM. Ultrasonography of the fetal thyroid: nomograms based on biparietal diameter and gestational age. J Ultrasound Med. 2001 Jun;20(6):613-7. doi: 10.7863/jum.2001.20.6.613.
- Luton D, Le Gac I, Vuillard E, Castanet M, Guibourdenche J, Noel M, Toubert ME, Leger J, Boissinot C, Schlageter MH, Garel C, Tebeka B, Oury JF, Czernichow P, Polak M. Management of Graves' disease during pregnancy: the key role of fetal thyroid gland monitoring. J Clin Endocrinol Metab. 2005 Nov;90(11):6093-8. doi: 10.1210/jc.2004-2555. Epub 2005 Aug 23.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 440/VI-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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