Fetal Thyroid Ultrasound And Fetal Thyroid Hormones

Hypothyroidism in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02017080
• Other study ID #: 440/VI-3
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2013
• Last updated: January 5, 2015
• Start date: January 2014
• Est. completion date: January 2020

Study information

• Verified date: January 2015
• Source: University of Belgrade
• Contact: Svetlana S Spremovic- Radjenovic, MD PhD
• Phone: +38163696246
• Email: spremovics[@]gmail.com
• Is FDA regulated: No
• Health authority: Serbia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperthyroidism
• Hypothyroidism
• Hypothyroidism in Pregnancy
• Pregnancy Complicated by Hyperthyroidism

Locations

Country	Name	City	State
Serbia	Clinic for Gynecology and Obstetrics , Clinical Center of Serbia	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

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. — View Citation

Luton D, Le Gac I, Vuillard E, Castanet M, Guibourdenche J, Noel M, Toubert ME, Léger J, Boissinot C, Schlageter MH, Garel C, Tébeka B, Oury JF, Czernichow P, Polak M. Management of Graves' disease during pregnancy: the key role of fetal thyroid gland mon — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal thyroid size measured by ultrasonography		28th week of gestation	Yes
Secondary	Fetal fT4	Sampled at the same time when fetal thyroid measurement is done	28th week of gestation	Yes
Secondary	Fetal antithyroid antibodies	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	Yes
Secondary	Maternal fT4	Sampled at the same time as the fetal free thyroxin and fetal antithyroid antibodies	28th week of gestation	Yes
Secondary	Maternal TSH	Measured in the same sample as maternal fT4	28th week of gestation	Yes
Secondary	Maternal antithyroid antibodies	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	Yes