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Early Levothyroxine Treatment for Subclinical Hypothyroidism or Hypothyroxinemia in Pregnancy: The St Carlos Gestational and Thyroid Protocol

The optimal maternal levels of thyroid hormones (TH) during the first trimester of gestation have not been established, nor has the ideal moment to initiate levothyroxine treatment (LT) to improve the evolution of gestation and fetal development. Cut-off points for Thyroid-stimulating hormone (TSH)...

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Autores principales: Runkle, Isabelle, de Miguel, María Paz, Barabash, Ana, Cuesta, Martin, Diaz, Ángel, Duran, Alejandra, Familiar, Cristina, de la Torre, Nuria García, Herraiz, Miguel Ángel, Izquierdo, Nuria, Marcuello, Clara, Matia, Pilar, Melero, Verónica, Montañez, Carmen, Moraga, Inmaculada, Perez-Ferre, Natalia, Perez, Noelia, Assaf-Balut, Carla, Rubio, Miguel Ángel, Ruiz-Sanchez, Jorge Gabriel, Sanabria, Concepción, Torrejon, María José, Valerio, Johanna, del Valle, Laura, Calle-Pascual, Alfonso
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8560890/
https://www.ncbi.nlm.nih.gov/pubmed/34737722
http://dx.doi.org/10.3389/fendo.2021.743057
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author Runkle, Isabelle
de Miguel, María Paz
Barabash, Ana
Cuesta, Martin
Diaz, Ángel
Duran, Alejandra
Familiar, Cristina
de la Torre, Nuria García
Herraiz, Miguel Ángel
Izquierdo, Nuria
Diaz, Ángel
Marcuello, Clara
Matia, Pilar
Melero, Verónica
Montañez, Carmen
Moraga, Inmaculada
Perez-Ferre, Natalia
Perez, Noelia
Assaf-Balut, Carla
Rubio, Miguel Ángel
Ruiz-Sanchez, Jorge Gabriel
Sanabria, Concepción
Torrejon, María José
Valerio, Johanna
del Valle, Laura
Calle-Pascual, Alfonso
author_facet Runkle, Isabelle
de Miguel, María Paz
Barabash, Ana
Cuesta, Martin
Diaz, Ángel
Duran, Alejandra
Familiar, Cristina
de la Torre, Nuria García
Herraiz, Miguel Ángel
Izquierdo, Nuria
Diaz, Ángel
Marcuello, Clara
Matia, Pilar
Melero, Verónica
Montañez, Carmen
Moraga, Inmaculada
Perez-Ferre, Natalia
Perez, Noelia
Assaf-Balut, Carla
Rubio, Miguel Ángel
Ruiz-Sanchez, Jorge Gabriel
Sanabria, Concepción
Torrejon, María José
Valerio, Johanna
del Valle, Laura
Calle-Pascual, Alfonso
author_sort Runkle, Isabelle
collection PubMed
description The optimal maternal levels of thyroid hormones (TH) during the first trimester of gestation have not been established, nor has the ideal moment to initiate levothyroxine treatment (LT) to improve the evolution of gestation and fetal development. Cut-off points for Thyroid-stimulating hormone (TSH) <2.5 µIU/mL and free thyroxine (FT4)>7.5 pg/mL have been recommended. There are no data on whether initiation of LT <9th Gestational Week (GW) can have a favourable impact. OBJECTIVE: To define the TSH/FT4 percentiles corresponding with 2.5 µIU/mL and 7.5 pg/mL levels, respectively, at GW8 (Study 1), and evaluate the effects of protocol-based LT before GW9 on gestation evolution, in women with TSH ≥2.5 µIU/mL and/or FT4≤ 7.5 pg/mL (study 2). SUBJECTS: 2768 consecutive pregnant women attending the first gestational visit from 2013-2014 and 3026 from 2015-2016 were eligible for Study I and 2 respectively. A final 2043 (study 1) and 2069 (study 2) women were assessed in these studies. RESULTS: Study 1: The FT4 level of 7.5 pg/mL corresponds with the 17.9th percentile, a TSH level of 2.5 µIU/mL with the 75.8(th). Women with TSH ≥2.5 µIU/mL had a history of fetal losses more frequently than those <2.5 (OR 2.33 (95%CI): 1.58-3.12), as did those with FT4 ≤7.5 pg/ml compared to those >7.5 (OR 4.81; 3.25-8.89). Study 2: A total of 1259 women had optimal TSH/FT4 levels (Group 1), 672 (32.4%, Group 2) had suboptimal TSH or T4l, and 138 (6.7%, Group 3) had suboptimal values of both. 393 (58.5%) in Group 2 and 88 (63.8%) in Group 3 started LT before GW9. Mean (SD) GW24 levels were TSH: 1.96 ± 1.22 µIU/mL and FT4: 7.07 ± 1.25 pg/mL. The highest FT4 value was 12.84 pg/mL. The adjusted risk for an adverse event if LT was started early was 0.71 (0.43-0.91) for Group 2 and 0.80 (0.66-0.94) for Group 3. CONCLUSIONS: Early LT in women with suboptimum levels of TSH/FT4 (≥2.5µIU/mL/≤7.5 pg/ml) at or before GW9 is safe and improves gestation progression. These data support the recommendation to adopt these cut-off points for LT initiation, which should be started as early as possible.
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spelling pubmed-85608902021-11-03 Early Levothyroxine Treatment for Subclinical Hypothyroidism or Hypothyroxinemia in Pregnancy: The St Carlos Gestational and Thyroid Protocol Runkle, Isabelle de Miguel, María Paz Barabash, Ana Cuesta, Martin Diaz, Ángel Duran, Alejandra Familiar, Cristina de la Torre, Nuria García Herraiz, Miguel Ángel Izquierdo, Nuria Diaz, Ángel Marcuello, Clara Matia, Pilar Melero, Verónica Montañez, Carmen Moraga, Inmaculada Perez-Ferre, Natalia Perez, Noelia Assaf-Balut, Carla Rubio, Miguel Ángel Ruiz-Sanchez, Jorge Gabriel Sanabria, Concepción Torrejon, María José Valerio, Johanna del Valle, Laura Calle-Pascual, Alfonso Front Endocrinol (Lausanne) Endocrinology The optimal maternal levels of thyroid hormones (TH) during the first trimester of gestation have not been established, nor has the ideal moment to initiate levothyroxine treatment (LT) to improve the evolution of gestation and fetal development. Cut-off points for Thyroid-stimulating hormone (TSH) <2.5 µIU/mL and free thyroxine (FT4)>7.5 pg/mL have been recommended. There are no data on whether initiation of LT <9th Gestational Week (GW) can have a favourable impact. OBJECTIVE: To define the TSH/FT4 percentiles corresponding with 2.5 µIU/mL and 7.5 pg/mL levels, respectively, at GW8 (Study 1), and evaluate the effects of protocol-based LT before GW9 on gestation evolution, in women with TSH ≥2.5 µIU/mL and/or FT4≤ 7.5 pg/mL (study 2). SUBJECTS: 2768 consecutive pregnant women attending the first gestational visit from 2013-2014 and 3026 from 2015-2016 were eligible for Study I and 2 respectively. A final 2043 (study 1) and 2069 (study 2) women were assessed in these studies. RESULTS: Study 1: The FT4 level of 7.5 pg/mL corresponds with the 17.9th percentile, a TSH level of 2.5 µIU/mL with the 75.8(th). Women with TSH ≥2.5 µIU/mL had a history of fetal losses more frequently than those <2.5 (OR 2.33 (95%CI): 1.58-3.12), as did those with FT4 ≤7.5 pg/ml compared to those >7.5 (OR 4.81; 3.25-8.89). Study 2: A total of 1259 women had optimal TSH/FT4 levels (Group 1), 672 (32.4%, Group 2) had suboptimal TSH or T4l, and 138 (6.7%, Group 3) had suboptimal values of both. 393 (58.5%) in Group 2 and 88 (63.8%) in Group 3 started LT before GW9. Mean (SD) GW24 levels were TSH: 1.96 ± 1.22 µIU/mL and FT4: 7.07 ± 1.25 pg/mL. The highest FT4 value was 12.84 pg/mL. The adjusted risk for an adverse event if LT was started early was 0.71 (0.43-0.91) for Group 2 and 0.80 (0.66-0.94) for Group 3. CONCLUSIONS: Early LT in women with suboptimum levels of TSH/FT4 (≥2.5µIU/mL/≤7.5 pg/ml) at or before GW9 is safe and improves gestation progression. These data support the recommendation to adopt these cut-off points for LT initiation, which should be started as early as possible. Frontiers Media S.A. 2021-10-19 /pmc/articles/PMC8560890/ /pubmed/34737722 http://dx.doi.org/10.3389/fendo.2021.743057 Text en Copyright © 2021 Runkle, de Miguel, Barabash, Cuesta, Diaz, Duran, Familiar, de la Torre, Herraiz, Izquierdo, Diaz, Marcuello, Matia, Melero, Montañez, Moraga, Perez-Ferre, Perez, Assaf-Balut, Rubio, Ruiz-Sanchez, Sanabria, Torrejon, Valerio, del Valle and Calle-Pascual https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Endocrinology
Runkle, Isabelle
de Miguel, María Paz
Barabash, Ana
Cuesta, Martin
Diaz, Ángel
Duran, Alejandra
Familiar, Cristina
de la Torre, Nuria García
Herraiz, Miguel Ángel
Izquierdo, Nuria
Diaz, Ángel
Marcuello, Clara
Matia, Pilar
Melero, Verónica
Montañez, Carmen
Moraga, Inmaculada
Perez-Ferre, Natalia
Perez, Noelia
Assaf-Balut, Carla
Rubio, Miguel Ángel
Ruiz-Sanchez, Jorge Gabriel
Sanabria, Concepción
Torrejon, María José
Valerio, Johanna
del Valle, Laura
Calle-Pascual, Alfonso
Early Levothyroxine Treatment for Subclinical Hypothyroidism or Hypothyroxinemia in Pregnancy: The St Carlos Gestational and Thyroid Protocol
title Early Levothyroxine Treatment for Subclinical Hypothyroidism or Hypothyroxinemia in Pregnancy: The St Carlos Gestational and Thyroid Protocol
title_full Early Levothyroxine Treatment for Subclinical Hypothyroidism or Hypothyroxinemia in Pregnancy: The St Carlos Gestational and Thyroid Protocol
title_fullStr Early Levothyroxine Treatment for Subclinical Hypothyroidism or Hypothyroxinemia in Pregnancy: The St Carlos Gestational and Thyroid Protocol
title_full_unstemmed Early Levothyroxine Treatment for Subclinical Hypothyroidism or Hypothyroxinemia in Pregnancy: The St Carlos Gestational and Thyroid Protocol
title_short Early Levothyroxine Treatment for Subclinical Hypothyroidism or Hypothyroxinemia in Pregnancy: The St Carlos Gestational and Thyroid Protocol
title_sort early levothyroxine treatment for subclinical hypothyroidism or hypothyroxinemia in pregnancy: the st carlos gestational and thyroid protocol
topic Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8560890/
https://www.ncbi.nlm.nih.gov/pubmed/34737722
http://dx.doi.org/10.3389/fendo.2021.743057
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