Fetal Thyroid Ultrasound And Fetal Thyroid Hormones

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Belgrade
Sponsor:
Information provided by (Responsible Party):
Svetlana Spremovic Radjenovic, University of Belgrade
ClinicalTrials.gov Identifier:
NCT02017080
First received: December 15, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition
Pregnancy Complicated by Hyperthyroidism
Hypothyroidism in Pregnancy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Efficacy Of Non Invasive Diagnostic Procedures In Evaluating The Influence Of Maternal Autoimmune Thyroid Gland Disease On Fetus

Resource links provided by NLM:


Further study details as provided by University of Belgrade:

Primary Outcome Measures:
  • Fetal thyroid size measured by ultrasonography [ Time Frame: 28th week of gestation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fetal fT4 [ Time Frame: 28th week of gestation ] [ Designated as safety issue: Yes ]
    Sampled at the same time when fetal thyroid measurement is done

  • Fetal antithyroid antibodies [ Time Frame: 28th week of gestation ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Sampled at the same time as the fetal free thyroxin and fetal antithyroid antibodies

  • Maternal TSH [ Time Frame: 28th week of gestation ] [ Designated as safety issue: Yes ]
    Measured in the same sample as maternal fT4

  • Maternal antithyroid antibodies [ Time Frame: 28th week of gestation ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 300
Study Start Date: January 2014
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017080

Contacts
Contact: Svetlana S Spremovic- Radjenovic, MD PhD +38163696246 spremovics@gmail.com
Contact: Aleksandra M Gudovic, MD PhD +381641642631 sasagudovic@gmail.com

Locations
Serbia
Clinic for Gynecology and Obstetrics , Clinical Center of Serbia Not yet recruiting
Belgrade, Serbia, 11000
Contact: Svetlana S Spremovic-Radjenovic, MD PhD    +38163 696246    spremovics@gmail.com   
Contact: Aleksandra M Gudovic, MD PhD    +381 64 164 2631    sasagudovic@gmail.com   
Sub-Investigator: Aleksandra M Gudovic, MD PhD         
Sponsors and Collaborators
University of Belgrade
Investigators
Principal Investigator: Svetlana S Spremovic- Radjenovic, MD PhD Medical School of the University of Belgrade
  More Information

Publications:
Responsible Party: Svetlana Spremovic Radjenovic, Assistant professor, Gynecologyst and Obstetrician, sibspecialist in endocrinology, University of Belgrade
ClinicalTrials.gov Identifier: NCT02017080     History of Changes
Other Study ID Numbers: 440/VI-3
Study First Received: December 15, 2013
Last Updated: December 15, 2013
Health Authority: Serbia: Ethics Committee

Keywords provided by University of Belgrade:
fetal thyroid ultrasound
fetal fT4
antithyroid antibodies
pregnancy
autoimmune thyroid disease

Additional relevant MeSH terms:
Hyperthyroidism
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014