Fetal Thyroid Ultrasound And Fetal Thyroid Hormones

January 5, 2015 updated by: Svetlana Spremovic Radjenovic, University of Belgrade

Efficacy Of Non Invasive Diagnostic Procedures In Evaluating The Influence Of Maternal Autoimmune Thyroid Gland Disease On Fetus

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.

Study Overview

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

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Svetlana S Spremovic- Radjenovic, MD PhD
  • Phone Number: +38163696246
  • Email: spremovics@gmail.com

Study Contact Backup

Study Locations

      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinic for Gynecology and Obstetrics , Clinical Center of Serbia
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Aleksandra M Gudovic, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Groups are selected from State tertiary referral centre for Gynecology and Obstetrics

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fetal thyroid size measured by ultrasonography
Time Frame: 28th week of gestation
28th week of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal fT4
Time Frame: 28th week of gestation
Sampled at the same time when fetal thyroid measurement is done
28th week of gestation
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
28th week of gestation
Maternal fT4
Time Frame: 28th week of gestation
Sampled at the same time as the fetal free thyroxin and fetal antithyroid antibodies
28th week of gestation
Maternal TSH
Time Frame: 28th week of gestation
Measured in the same sample as maternal fT4
28th week of gestation
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
28th week of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Svetlana S Spremovic- Radjenovic, MD PhD, Medical School of the University of Belgrade

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

December 15, 2013

First Submitted That Met QC Criteria

December 15, 2013

First Posted (ESTIMATE)

December 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 5, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

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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