Fetal Thyroid Ultrasound And Fetal Thyroid Hormones

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy Complicated by Hyperthyroidism Hypothyroidism in Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Hypothyroid pregnant women

Autoimmune hypothyroidism diagnosed and treated by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination

No interventions assigned to this group

Healthy pregnant women

Euthyroid women with uncomplicated pregnancies, with antithyroid antibodies within reference ranges

No interventions assigned to this group

Eligibility Criteria

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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

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No