Clinical trial NCT02017080: Fetal Thyroid Ultrasound And Fetal Thyroid Hormones
Official title: Efficacy Of Non Invasive Diagnostic Procedures In Evaluating The Influence Of Maternal Autoimmune Thyroid Gland Disease On Fetus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Complicated by Hyperthyroidism
Hypothyroidism in Pregnancy
Keywords: fetal thyroid ultrasound
fetal fT4
antithyroid antibodies
pregnancy
autoimmune thyroid disease
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Groups are selected from State tertiary referral centre for Gynecology and Obstetrics

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.

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 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

Primary outcomes:
measure: Fetal thyroid size measured by ultrasonography
timeFrame: 28th week of gestation
Secondary outcomes:
measure: Fetal fT4
timeFrame: 28th week of gestation
measure: Fetal antithyroid antibodies
timeFrame: 28th week of gestation
measure: Maternal fT4
timeFrame: 28th week of gestation
measure: Maternal TSH
timeFrame: 28th week of gestation
measure: Maternal antithyroid antibodies
timeFrame: 28th week of gestation
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for Gynecology and Obstetrics , Clinical Center of Serbia
Study officials:
affiliation: Medical School of the University of Belgrade
name: Svetlana S Spremovic- Radjenovic, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.7863/jum.2001.20.6.613.
citation: 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.