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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02017080
Enrollment
300
Registered
2013-12-20
Start date
2014-01-31
Completion date
2020-01-31
Last updated
2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism in Pregnancy, Pregnancy Complicated by Hyperthyroidism

Keywords

fetal thyroid ultrasound, fetal fT4, antithyroid antibodies, pregnancy, autoimmune thyroid disease

Brief summary

Non invasive methods: maternal antithyroid antibodies and ultrasound measurement of the fetal thyroid gland could be an important tool for detecting fetal thyroid dysfunction in mothers with autoimmune thyroid disease.

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.

Interventions

None listed

Sponsors

University of Belgrade
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Fetal thyroid size measured by ultrasonography28th week of gestation

Secondary

MeasureTime frameDescription
Fetal fT428th week of gestationSampled at the same time when fetal thyroid measurement is done
Fetal antithyroid antibodies28th week of gestationFetal antithyroid antibodies: thyroid peroxidase (TPO), TSH receptor (TRAK), thyroglobuline (Tg) antibodies, will be measure in the same sample as fetal fT4
Maternal fT428th week of gestationSampled at the same time as the fetal free thyroxin and fetal antithyroid antibodies
Maternal TSH28th week of gestationMeasured in the same sample as maternal fT4
Maternal antithyroid antibodies28th week of gestationMeasured 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

Countries

Serbia

Contacts

Primary ContactSvetlana S Spremovic- Radjenovic, MD PhD
spremovics@gmail.com+38163696246
Backup ContactAleksandra M Gudovic, MD PhD
sasagudovic@gmail.com+381641642631

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026