Pregnancy Complicated by HyperthyroidismNCT02017080
Fetal Thyroid Ultrasound And Fetal Thyroid Hormones
An observational study of Pregnancy Complicated by Hyperthyroidism and Hypothyroidism in Pregnancy, run by University of Belgrade at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Pregnancy Complicated by Hyperthyroidism, Hypothyroidism in Pregnancy
- How many people
- 300 participants
- Where
- 1 siteSerbia
- Study dates
- Jan 2014to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Groups are selected from State tertiary referral centre for Gynecology and Obstetrics
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Serbia1 site, 1 recruiting
- Recruiting
Clinic for Gynecology and Obstetrics , Clinical Center of Serbia
Belgrade, 11000
Svetlana S Spremovic-Radjenovic, MD PhD, +38163 696246, spremovics@gmail.com
Aleksandra M Gudovic, MD PhD, +381 64 164 2631, sasagudovic@gmail.com
About this study
Official title: 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.
Read the 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.
- Keywords
- fetal thyroid ultrasound, fetal fT4, antithyroid antibodies, pregnancy, autoimmune thyroid disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Fetal thyroid size measured by ultrasonography
Measured: 28th week of gestation
Secondary outcomes (5)
Fetal fT4
Sampled at the same time when fetal thyroid measurement is done
Measured: 28th week of gestation
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
Measured: 28th week of gestation
Maternal fT4
Sampled at the same time as the fetal free thyroxin and fetal antithyroid antibodies
Measured: 28th week of gestation
Maternal TSH
Measured in the same sample as maternal fT4
Measured: 28th week of gestation
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
Measured: 28th week of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Complicated by HyperthyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svetlana Spremovic Radjenovic, University of Belgrade
- Investigators
- Svetlana S Spremovic- Radjenovic, MD PhD, Principal investigator, Medical School of the University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017080
- Sponsor's protocol ID
- 440/VI-3
- Status last verified
- Jan 2015
- First submitted
- 15 Dec 2013
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 9578813Ranzini 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.
PubMed 11400935Luton 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.
PubMed 16118343
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Non Invasive Diagnostic Procedures In Evaluating The Influence Of Maternal Autoimmune Thyroid Gland Disease On Fetus
- ClinicalTrials.gov ID
- NCT02017080
- Acronym / sponsor ID
- 440/VI-3
- Keywords
- fetal thyroid ultrasound, fetal fT4, antithyroid antibodies, pregnancy, autoimmune thyroid disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Groups are selected from State tertiary referral centre for Gynecology and Obstetrics
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal thyroid size measured by ultrasonography
Time frame: 28th week of gestation
5 secondary outcomes
Fetal fT4
Time frame: 28th week of gestation
Fetal antithyroid antibodies
Time frame: 28th week of gestation
Maternal fT4
Time frame: 28th week of gestation
Maternal TSH
Time frame: 28th week of gestation
Maternal antithyroid antibodies
Time frame: 28th week of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Background: PubMed 9578813Achiron 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.
- Background: PubMed 11400935Ranzini 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.
- Results publication: PubMed 16118343Luton 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svetlana S Spremovic- Radjenovic, MD PhD principal investigator
Medical School of the University of Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complicated by Hyperthyroidism and Hypothyroidism in Pregnancy, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Svetlana S Spremovic- Radjenovic, MD PhD (+38163696246, spremovics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal thyroid size measured by ultrasonography (time frame: 28th week of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02017080, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.