TY - JOUR

T1 - Hyperthyroidism in pregnancy

T2 - design and methodology of a Danish multicenter study

AU - Torp, Nanna Maria Uldall

AU - Pedersen, Inge Bülow

AU - Carlé, Allan

AU - Karmisholt, Jesper Scott

AU - Ebbehøj, Eva

AU - Grove-Laugesen, Diana

AU - Brix, Thomas Heiberg

AU - Bonnema, Steen Joop

AU - Schrijvers, Bieke F.

AU - Nygaard, Birte

AU - Sigurd, Lena Bjergved

AU - Feldt-Rasmussen, Ulla

AU - Klose, Marianne

AU - Rasmussen, Åse Krogh

AU - Andersen, Stig

AU - Andersen, Stine Linding

N1 - Publisher Copyright: © 2023, The Author(s).

PY - 2023

Y1 - 2023

N2 - Background: Graves’ disease (GD) is the main cause of hyperthyroidism in women of the fertile age. In pregnant women, the disease should be carefully managed and controlled to prevent maternal and fetal complications. Observational studies provide evidence of the adverse effects of untreated hyperthyroidism in pregnancy and have in more recent years substantiated a risk of teratogenic side effects with the use of antithyroid drugs (ATDs). These findings have challenged the clinical recommendations regarding the choice of treatment when patients become pregnant. To extend observational findings and support future clinical practice, a systematic collection of detailed clinical data in and around pregnancy is needed. Methods: With the aim of collecting clinical and biochemical data, a Danish multicenter study entitled ‘Pregnancy Investigations on Thyroid Disease’ (PRETHYR) was initiated in 2021. We here describe the design and methodology of the first study part of PRETHYR. This part focuses on maternal hyperthyroidism and recruits female patients in Denmark with a past or present diagnosis of GD, who become pregnant, as well as women who are treated with ATDs in the pregnancy, irrespective of the underlying etiology. The women are included during clinical management from endocrine hospital departments in Denmark, and study participation includes patient questionnaires in pregnancy and postpartum as well as review of medical records from the mother and the child. Results: Data collection was initiated on November 1, 2021 and covered all five Danish Regions from March 1, 2022. Consecutive study inclusion will continue, and we here report the first status of inclusion. As of November 1, 2022, a total of 62 women have been included in median pregnancy week 19 (interquartile range (IQR): 10–27) with a median maternal age of 31.4 years (IQR: 28.5–35.1). At inclusion, 26 women (41.9%) reported current use of thyroid medication; ATDs (n = 14), Levothyroxine (n = 12). Conclusion: This report describes a newly established systematic and nationwide collection of detailed clinical data on pregnant women with hyperthyroidism and their offspring. Considering the course and relatively low prevalence of GD in pregnant women, such nationwide design is essential to establish a sufficiently large cohort.

AB - Background: Graves’ disease (GD) is the main cause of hyperthyroidism in women of the fertile age. In pregnant women, the disease should be carefully managed and controlled to prevent maternal and fetal complications. Observational studies provide evidence of the adverse effects of untreated hyperthyroidism in pregnancy and have in more recent years substantiated a risk of teratogenic side effects with the use of antithyroid drugs (ATDs). These findings have challenged the clinical recommendations regarding the choice of treatment when patients become pregnant. To extend observational findings and support future clinical practice, a systematic collection of detailed clinical data in and around pregnancy is needed. Methods: With the aim of collecting clinical and biochemical data, a Danish multicenter study entitled ‘Pregnancy Investigations on Thyroid Disease’ (PRETHYR) was initiated in 2021. We here describe the design and methodology of the first study part of PRETHYR. This part focuses on maternal hyperthyroidism and recruits female patients in Denmark with a past or present diagnosis of GD, who become pregnant, as well as women who are treated with ATDs in the pregnancy, irrespective of the underlying etiology. The women are included during clinical management from endocrine hospital departments in Denmark, and study participation includes patient questionnaires in pregnancy and postpartum as well as review of medical records from the mother and the child. Results: Data collection was initiated on November 1, 2021 and covered all five Danish Regions from March 1, 2022. Consecutive study inclusion will continue, and we here report the first status of inclusion. As of November 1, 2022, a total of 62 women have been included in median pregnancy week 19 (interquartile range (IQR): 10–27) with a median maternal age of 31.4 years (IQR: 28.5–35.1). At inclusion, 26 women (41.9%) reported current use of thyroid medication; ATDs (n = 14), Levothyroxine (n = 12). Conclusion: This report describes a newly established systematic and nationwide collection of detailed clinical data on pregnant women with hyperthyroidism and their offspring. Considering the course and relatively low prevalence of GD in pregnant women, such nationwide design is essential to establish a sufficiently large cohort.

KW - Antithyroid

KW - Gestation

KW - Graves’ disease

KW - Levothyroxine

KW - Methimazole

KW - Propylthiouracil

U2 - 10.1186/s13044-023-00154-8

DO - 10.1186/s13044-023-00154-8

M3 - Journal article

C2 - 37041614

AN - SCOPUS:85153099608

VL - 16

JO - Thyroid Research

JF - Thyroid Research

SN - 1756-6614

M1 - 11

ER -