Fetal Thyroid Ultrasound And Fetal Thyroid Hormones

• ClinicalTrials.gov Identifier: NCT02017080
• Recruitment Status: Unknown
• First Posted: December 20, 2013
• Last Update Posted: January 6, 2015
• Sponsor: University of Belgrade
• Information provided by (Responsible Party): Svetlana Spremovic Radjenovic, University of Belgrade

Study Description

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.

Condition or disease
Pregnancy Complicated by Hyperthyroidism; Hypothyroidism in Pregnancy

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 Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• 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
• Study Start Date: January 2014
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: January 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Fetal thyroid size measured by ultrasonography [ Time Frame: 28th week of gestation ]

Secondary Outcome Measures :

1. Fetal fT4 [ Time Frame: 28th week of gestation ]
   Sampled at the same time when fetal thyroid measurement is done
2. 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
3. Maternal fT4 [ Time Frame: 28th week of gestation ]
   Sampled at the same time as the fetal free thyroxin and fetal antithyroid antibodies
4. Maternal TSH [ Time Frame: 28th week of gestation ]
   Measured in the same sample as maternal fT4
5. 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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 45 Years (Adult)
• Sexes 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

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; 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 of Results:

Luton D, Le Gac I, Vuillard E, Castanet M, Guibourdenche J, Noel M, Toubert ME, Leger J, Boissinot C, Schlageter MH, Garel C, Tebeka B, Oury JF, Czernichow P, Polak M. Management of Graves' disease during pregnancy: the key role of fetal thyroid gland monitoring. J Clin Endocrinol Metab. 2005 Nov;90(11):6093-8. doi: 10.1210/jc.2004-2555. Epub 2005 Aug 23.

Other Publications:

Achiron R, Rotstein Z, Lipitz S, Karasik A, Seidman DS. The development of the foetal thyroid: in utero ultrasonographic measurements. Clin Endocrinol (Oxf). 1998 Mar;48(3):259-64. doi: 10.1046/j.1365-2265.1998.00388.x.

Ranzini AC, Ananth CV, Smulian JC, Kung M, Limbachia A, Vintzileos AM. Ultrasonography of the fetal thyroid: nomograms based on biparietal diameter and gestational age. J Ultrasound Med. 2001 Jun;20(6):613-7. doi: 10.7863/jum.2001.20.6.613.

• Responsible Party: Svetlana Spremovic Radjenovic, Assistant professor, Gynecologyst and Obstetrician, sibspecialist in endocrinology, University of Belgrade
• ClinicalTrials.gov Identifier: NCT02017080
• Other Study ID Numbers: 440/VI-3
• First Posted: December 20, 2013
• Last Update Posted: January 6, 2015
• Last Verified: January 2015

Keywords provided by Svetlana Spremovic Radjenovic, University of Belgrade:

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

Additional relevant MeSH terms:

Thyroid Diseases; Hypothyroidism; Hyperthyroidism; Endocrine System Diseases