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Third-Generation Thyrotropin Receptor Antibody (TRAb) assay for predicting neonatal thyroid dysfunction in pregnant women with Graves’ disease

Purpose The aim is to validate the third generation Thyrotropin receptor antibody (TRAb) assay for predicting neonatal thyroid dysfunction and adverse pregnancy outcomes in pregnant women with Graves’ disease. Methods This prospective cohort study was conducted in TRAb positive pregnant women with G...

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Published in:Endocrine 2024-05, Vol.84 (2), p.500-508
Main Authors: Priyanka, Raghavendran, Sridhar, Subbiah, Sumathi, Baskaran, Jeyaraj, Ashok Raja, Natarajan, Vasanthiy, Subbiah, Eagappan, Raghavan, Kasthuri Santharam, Sangumani, Jayaraman
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creator Priyanka, Raghavendran
Sridhar, Subbiah
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Raghavan, Kasthuri Santharam
Sangumani, Jayaraman
description Purpose The aim is to validate the third generation Thyrotropin receptor antibody (TRAb) assay for predicting neonatal thyroid dysfunction and adverse pregnancy outcomes in pregnant women with Graves’ disease. Methods This prospective cohort study was conducted in TRAb positive pregnant women with Graves’ disease and their off springs. The primary outcome was to assess different forms of neonatal thyroid dysfunction in relation to maternal and neonatal TRAb levels. The secondary outcome was to predict adverse pregnancy outcomes by using maternal TRAb levels. Serum T3, FT4, TSH, TRAb levels were measured using electrochemiluminescence immunoassay. Results 51 pregnant women were included. Five women had adverse pregnancy outcomes, TRAb levels of > 19.06 IU/L (10.9 times the upper limit of normal (ULN)) predicted adverse pregnancy outcomes with 100% sensitivity and 93.5% specificity. Among the 46 successful live births, 13 (28.3%) had neonatal thyroid dysfunction. Out of 13 neonates, 7 (32%) had neonatal thyrotoxicosis, 4 (18%) had primary hypothyroidism, and 2 (9%) had central hypothyroidism. Third trimester maternal TRAb levels of > 7.99 IU/L (4.6 times the ULN)and day three neonatal TRAb levels of > 5.03 IU/L (2.9 times the ULN), predicted the neonatal thyrotoxicosis with 100% sensitivity and 97.4% specificity. Conclusion Very high maternal third generation TRAb levels strongly predicted the adverse pregnancy outcomes and neonatal thyroid dysfunction in pregnant women with Graves’ disease. Neonatal thyroid function test along with the TRAb levels strongly correlated with different forms of neonatal thyroid dysfunction and is very useful in avoiding inadvertent treatment to neonates.
doi_str_mv 10.1007/s12020-023-03569-3
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Methods This prospective cohort study was conducted in TRAb positive pregnant women with Graves’ disease and their off springs. The primary outcome was to assess different forms of neonatal thyroid dysfunction in relation to maternal and neonatal TRAb levels. The secondary outcome was to predict adverse pregnancy outcomes by using maternal TRAb levels. Serum T3, FT4, TSH, TRAb levels were measured using electrochemiluminescence immunoassay. Results 51 pregnant women were included. Five women had adverse pregnancy outcomes, TRAb levels of &gt; 19.06 IU/L (10.9 times the upper limit of normal (ULN)) predicted adverse pregnancy outcomes with 100% sensitivity and 93.5% specificity. Among the 46 successful live births, 13 (28.3%) had neonatal thyroid dysfunction. Out of 13 neonates, 7 (32%) had neonatal thyrotoxicosis, 4 (18%) had primary hypothyroidism, and 2 (9%) had central hypothyroidism. Third trimester maternal TRAb levels of &gt; 7.99 IU/L (4.6 times the ULN)and day three neonatal TRAb levels of &gt; 5.03 IU/L (2.9 times the ULN), predicted the neonatal thyrotoxicosis with 100% sensitivity and 97.4% specificity. Conclusion Very high maternal third generation TRAb levels strongly predicted the adverse pregnancy outcomes and neonatal thyroid dysfunction in pregnant women with Graves’ disease. Neonatal thyroid function test along with the TRAb levels strongly correlated with different forms of neonatal thyroid dysfunction and is very useful in avoiding inadvertent treatment to neonates.</description><identifier>ISSN: 1559-0100</identifier><identifier>ISSN: 1355-008X</identifier><identifier>EISSN: 1559-0100</identifier><identifier>DOI: 10.1007/s12020-023-03569-3</identifier><identifier>PMID: 37861945</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Autoantibodies - blood ; Diabetes ; Endocrinology ; Female ; Graves disease ; Graves Disease - blood ; Graves Disease - complications ; Graves Disease - diagnosis ; Graves Disease - immunology ; Humanities and Social Sciences ; Humans ; Hypothyroidism ; Immunoglobulins, Thyroid-Stimulating - blood ; Infant, Newborn ; Internal Medicine ; Medicine ; Medicine &amp; Public Health ; multidisciplinary ; Neonates ; Original Article ; Pregnancy ; Pregnancy Complications - blood ; Pregnancy Complications - immunology ; Pregnancy Outcome - epidemiology ; Prospective Studies ; Receptors, Thyrotropin - immunology ; Science ; Sensitivity and Specificity ; Thyroid ; Thyroid diseases ; Thyroid Function Tests ; Thyroid gland ; Thyroid-stimulating hormone ; Thyrotoxicosis ; Triiodothyronine ; Womens health ; Young Adult</subject><ispartof>Endocrine, 2024-05, Vol.84 (2), p.500-508</ispartof><rights>The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-b4163ee2c345d038f77fe5038d884c26fb1df219fc35717927f278a9e64a48ce3</citedby><cites>FETCH-LOGICAL-c375t-b4163ee2c345d038f77fe5038d884c26fb1df219fc35717927f278a9e64a48ce3</cites><orcidid>0000-0001-5451-0848</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27922,27923</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37861945$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Priyanka, Raghavendran</creatorcontrib><creatorcontrib>Sridhar, Subbiah</creatorcontrib><creatorcontrib>Sumathi, Baskaran</creatorcontrib><creatorcontrib>Jeyaraj, Ashok Raja</creatorcontrib><creatorcontrib>Natarajan, Vasanthiy</creatorcontrib><creatorcontrib>Subbiah, Eagappan</creatorcontrib><creatorcontrib>Raghavan, Kasthuri Santharam</creatorcontrib><creatorcontrib>Sangumani, Jayaraman</creatorcontrib><title>Third-Generation Thyrotropin Receptor Antibody (TRAb) assay for predicting neonatal thyroid dysfunction in pregnant women with Graves’ disease</title><title>Endocrine</title><addtitle>Endocrine</addtitle><addtitle>Endocrine</addtitle><description>Purpose The aim is to validate the third generation Thyrotropin receptor antibody (TRAb) assay for predicting neonatal thyroid dysfunction and adverse pregnancy outcomes in pregnant women with Graves’ disease. Methods This prospective cohort study was conducted in TRAb positive pregnant women with Graves’ disease and their off springs. The primary outcome was to assess different forms of neonatal thyroid dysfunction in relation to maternal and neonatal TRAb levels. The secondary outcome was to predict adverse pregnancy outcomes by using maternal TRAb levels. Serum T3, FT4, TSH, TRAb levels were measured using electrochemiluminescence immunoassay. Results 51 pregnant women were included. Five women had adverse pregnancy outcomes, TRAb levels of &gt; 19.06 IU/L (10.9 times the upper limit of normal (ULN)) predicted adverse pregnancy outcomes with 100% sensitivity and 93.5% specificity. Among the 46 successful live births, 13 (28.3%) had neonatal thyroid dysfunction. Out of 13 neonates, 7 (32%) had neonatal thyrotoxicosis, 4 (18%) had primary hypothyroidism, and 2 (9%) had central hypothyroidism. Third trimester maternal TRAb levels of &gt; 7.99 IU/L (4.6 times the ULN)and day three neonatal TRAb levels of &gt; 5.03 IU/L (2.9 times the ULN), predicted the neonatal thyrotoxicosis with 100% sensitivity and 97.4% specificity. Conclusion Very high maternal third generation TRAb levels strongly predicted the adverse pregnancy outcomes and neonatal thyroid dysfunction in pregnant women with Graves’ disease. Neonatal thyroid function test along with the TRAb levels strongly correlated with different forms of neonatal thyroid dysfunction and is very useful in avoiding inadvertent treatment to neonates.</description><subject>Adult</subject><subject>Autoantibodies - blood</subject><subject>Diabetes</subject><subject>Endocrinology</subject><subject>Female</subject><subject>Graves disease</subject><subject>Graves Disease - blood</subject><subject>Graves Disease - complications</subject><subject>Graves Disease - diagnosis</subject><subject>Graves Disease - immunology</subject><subject>Humanities and Social Sciences</subject><subject>Humans</subject><subject>Hypothyroidism</subject><subject>Immunoglobulins, Thyroid-Stimulating - blood</subject><subject>Infant, Newborn</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>multidisciplinary</subject><subject>Neonates</subject><subject>Original Article</subject><subject>Pregnancy</subject><subject>Pregnancy Complications - blood</subject><subject>Pregnancy Complications - immunology</subject><subject>Pregnancy Outcome - epidemiology</subject><subject>Prospective Studies</subject><subject>Receptors, Thyrotropin - immunology</subject><subject>Science</subject><subject>Sensitivity and Specificity</subject><subject>Thyroid</subject><subject>Thyroid diseases</subject><subject>Thyroid Function Tests</subject><subject>Thyroid gland</subject><subject>Thyroid-stimulating hormone</subject><subject>Thyrotoxicosis</subject><subject>Triiodothyronine</subject><subject>Womens health</subject><subject>Young Adult</subject><issn>1559-0100</issn><issn>1355-008X</issn><issn>1559-0100</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9kctu1DAUhiNERUvhBVggS2zKIuBLEjvLUdUOSJWQqmFtOfbxjKsZO9gOVXY8Qrd9PZ4ET6dc1AUrH-l85_Ox_6p6Q_AHgjH_mAjFFNeYshqztutr9qw6IW3b17j0n_9TH1cvU7rBmFLa8RfVMeOiI33TnlR3q42Lpl6Ch6iyCx6tNnMMOYbReXQNGsYcIlr47IZgZnS2ul4M75FKSc3Ils4YwTidnV8jD8GrrLYo7xXOIDMnO3n9oC22gq698hndhh14dOvyBi2j-g7p5497ZFwCleBVdWTVNsHrx_O0-np5sTr_VF99WX4-X1zVmvE210NDOgZANWtag5mwnFtoS2GEaDTt7ECMpaS3mrWc8J5yS7lQPXSNaoQGdlqdHbxjDN8mSFnuXNKw3aryjClJKkT5OSYoL-i7J-hNmKIv20mGW4oFaTpWKHqgdAwpRbByjG6n4iwJlvu85CEvWfKSD3nJ_dDbR_U07MD8GfkdUAHYAUil5dcQ_979H-0vvEGi9w</recordid><startdate>20240501</startdate><enddate>20240501</enddate><creator>Priyanka, Raghavendran</creator><creator>Sridhar, Subbiah</creator><creator>Sumathi, Baskaran</creator><creator>Jeyaraj, Ashok Raja</creator><creator>Natarajan, Vasanthiy</creator><creator>Subbiah, Eagappan</creator><creator>Raghavan, Kasthuri Santharam</creator><creator>Sangumani, Jayaraman</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-5451-0848</orcidid></search><sort><creationdate>20240501</creationdate><title>Third-Generation Thyrotropin Receptor Antibody (TRAb) assay for predicting neonatal thyroid dysfunction in pregnant women with Graves’ disease</title><author>Priyanka, Raghavendran ; Sridhar, Subbiah ; Sumathi, Baskaran ; Jeyaraj, Ashok Raja ; Natarajan, Vasanthiy ; Subbiah, Eagappan ; Raghavan, Kasthuri Santharam ; Sangumani, Jayaraman</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-b4163ee2c345d038f77fe5038d884c26fb1df219fc35717927f278a9e64a48ce3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Autoantibodies - blood</topic><topic>Diabetes</topic><topic>Endocrinology</topic><topic>Female</topic><topic>Graves disease</topic><topic>Graves Disease - blood</topic><topic>Graves Disease - complications</topic><topic>Graves Disease - diagnosis</topic><topic>Graves Disease - immunology</topic><topic>Humanities and Social Sciences</topic><topic>Humans</topic><topic>Hypothyroidism</topic><topic>Immunoglobulins, Thyroid-Stimulating - blood</topic><topic>Infant, Newborn</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>multidisciplinary</topic><topic>Neonates</topic><topic>Original Article</topic><topic>Pregnancy</topic><topic>Pregnancy Complications - blood</topic><topic>Pregnancy Complications - immunology</topic><topic>Pregnancy Outcome - epidemiology</topic><topic>Prospective Studies</topic><topic>Receptors, Thyrotropin - immunology</topic><topic>Science</topic><topic>Sensitivity and Specificity</topic><topic>Thyroid</topic><topic>Thyroid diseases</topic><topic>Thyroid Function Tests</topic><topic>Thyroid gland</topic><topic>Thyroid-stimulating hormone</topic><topic>Thyrotoxicosis</topic><topic>Triiodothyronine</topic><topic>Womens health</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Priyanka, Raghavendran</creatorcontrib><creatorcontrib>Sridhar, Subbiah</creatorcontrib><creatorcontrib>Sumathi, Baskaran</creatorcontrib><creatorcontrib>Jeyaraj, Ashok Raja</creatorcontrib><creatorcontrib>Natarajan, Vasanthiy</creatorcontrib><creatorcontrib>Subbiah, Eagappan</creatorcontrib><creatorcontrib>Raghavan, Kasthuri Santharam</creatorcontrib><creatorcontrib>Sangumani, Jayaraman</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Endocrine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Priyanka, Raghavendran</au><au>Sridhar, Subbiah</au><au>Sumathi, Baskaran</au><au>Jeyaraj, Ashok Raja</au><au>Natarajan, Vasanthiy</au><au>Subbiah, Eagappan</au><au>Raghavan, Kasthuri Santharam</au><au>Sangumani, Jayaraman</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Third-Generation Thyrotropin Receptor Antibody (TRAb) assay for predicting neonatal thyroid dysfunction in pregnant women with Graves’ disease</atitle><jtitle>Endocrine</jtitle><stitle>Endocrine</stitle><addtitle>Endocrine</addtitle><date>2024-05-01</date><risdate>2024</risdate><volume>84</volume><issue>2</issue><spage>500</spage><epage>508</epage><pages>500-508</pages><issn>1559-0100</issn><issn>1355-008X</issn><eissn>1559-0100</eissn><abstract>Purpose The aim is to validate the third generation Thyrotropin receptor antibody (TRAb) assay for predicting neonatal thyroid dysfunction and adverse pregnancy outcomes in pregnant women with Graves’ disease. Methods This prospective cohort study was conducted in TRAb positive pregnant women with Graves’ disease and their off springs. The primary outcome was to assess different forms of neonatal thyroid dysfunction in relation to maternal and neonatal TRAb levels. The secondary outcome was to predict adverse pregnancy outcomes by using maternal TRAb levels. Serum T3, FT4, TSH, TRAb levels were measured using electrochemiluminescence immunoassay. Results 51 pregnant women were included. Five women had adverse pregnancy outcomes, TRAb levels of &gt; 19.06 IU/L (10.9 times the upper limit of normal (ULN)) predicted adverse pregnancy outcomes with 100% sensitivity and 93.5% specificity. Among the 46 successful live births, 13 (28.3%) had neonatal thyroid dysfunction. Out of 13 neonates, 7 (32%) had neonatal thyrotoxicosis, 4 (18%) had primary hypothyroidism, and 2 (9%) had central hypothyroidism. Third trimester maternal TRAb levels of &gt; 7.99 IU/L (4.6 times the ULN)and day three neonatal TRAb levels of &gt; 5.03 IU/L (2.9 times the ULN), predicted the neonatal thyrotoxicosis with 100% sensitivity and 97.4% specificity. Conclusion Very high maternal third generation TRAb levels strongly predicted the adverse pregnancy outcomes and neonatal thyroid dysfunction in pregnant women with Graves’ disease. Neonatal thyroid function test along with the TRAb levels strongly correlated with different forms of neonatal thyroid dysfunction and is very useful in avoiding inadvertent treatment to neonates.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>37861945</pmid><doi>10.1007/s12020-023-03569-3</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-5451-0848</orcidid></addata></record>
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subjects Adult
Autoantibodies - blood
Diabetes
Endocrinology
Female
Graves disease
Graves Disease - blood
Graves Disease - complications
Graves Disease - diagnosis
Graves Disease - immunology
Humanities and Social Sciences
Humans
Hypothyroidism
Immunoglobulins, Thyroid-Stimulating - blood
Infant, Newborn
Internal Medicine
Medicine
Medicine & Public Health
multidisciplinary
Neonates
Original Article
Pregnancy
Pregnancy Complications - blood
Pregnancy Complications - immunology
Pregnancy Outcome - epidemiology
Prospective Studies
Receptors, Thyrotropin - immunology
Science
Sensitivity and Specificity
Thyroid
Thyroid diseases
Thyroid Function Tests
Thyroid gland
Thyroid-stimulating hormone
Thyrotoxicosis
Triiodothyronine
Womens health
Young Adult
title Third-Generation Thyrotropin Receptor Antibody (TRAb) assay for predicting neonatal thyroid dysfunction in pregnant women with Graves’ disease
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