Fetal Thyroid Ultrasound And Fetal Thyroid Hormones
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|ClinicalTrials.gov Identifier: NCT02017080|
Recruitment Status : Unknown
Verified January 2015 by Svetlana Spremovic Radjenovic, University of Belgrade.
Recruitment status was: Recruiting
First Posted : December 20, 2013
Last Update Posted : January 6, 2015
|Condition or disease|
|Pregnancy Complicated by Hyperthyroidism Hypothyroidism in Pregnancy|
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 :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Efficacy Of Non Invasive Diagnostic Procedures In Evaluating The Influence Of Maternal Autoimmune Thyroid Gland Disease On Fetus|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
Hyperthyroid pregnant women
Autoimmune hyperthyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound clinical examination
Hypothyroid pregnant women
Autoimmune hypothyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination
Healthy pregnant women
Euthyroid women with uncomplicated pregnancies, with antithyroid antibodies within reference ranges
- Fetal thyroid size measured by ultrasonography [ Time Frame: 28th week of gestation ]
- Fetal fT4 [ Time Frame: 28th week of gestation ]Sampled at the same time when fetal thyroid measurement is done
- Fetal antithyroid antibodies [ Time Frame: 28th week of gestation ]Fetal antithyroid antibodies: thyroid peroxidase (TPO), TSH receptor (TRAK), thyroglobuline (Tg) antibodies, will be measure in the same sample as fetal fT4
- Maternal fT4 [ Time Frame: 28th week of gestation ]Sampled at the same time as the fetal free thyroxin and fetal antithyroid antibodies
- Maternal TSH [ Time Frame: 28th week of gestation ]Measured in the same sample as maternal fT4
- Maternal antithyroid antibodies [ Time Frame: 28th week of gestation ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017080
|Contact: Svetlana S Spremovic- Radjenovic, MD PhDfirstname.lastname@example.org|
|Contact: Aleksandra M Gudovic, MD PhDemail@example.com|
|Clinic for Gynecology and Obstetrics , Clinical Center of Serbia||Recruiting|
|Belgrade, Serbia, 11000|
|Contact: Svetlana S Spremovic-Radjenovic, MD PhD +38163 696246 firstname.lastname@example.org|
|Contact: Aleksandra M Gudovic, MD PhD +381 64 164 2631 email@example.com|
|Sub-Investigator: Aleksandra M Gudovic, MD PhD|
|Principal Investigator:||Svetlana S Spremovic- Radjenovic, MD PhD||Medical School of the University of Belgrade|