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Related Experiment Video

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Author Spotlight: Integrating Ultrasound Imaging with Biochemical Markers for Thyroid Disease Diagnosis
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Development of trimester-specific reference intervals for thyroid hormones based on real-world data using a maximum

Xiaoyan Chen1, Yinrui Zou2, Yunxia Chu1

  • 1Department of Laboratory Medicine, Linyi Maternal and Child Healthcare Hospital, Luozhuang District, Linyi City 276016, Shandong Province, China.

Laboratory Medicine
|November 12, 2025
PubMed
Summary
This summary is machine-generated.

New trimester-specific reference intervals for thyroid-stimulating hormone (TSH) and free thyroxine (FT4) were established using real-world pregnancy data. These intervals, derived from the maximum likelihood method, show narrower limits for TSH compared to existing guidelines.

Keywords:
indirect methodmaximum likelihood methodreference intervalstrimester-specific thyroid hormones

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Area of Science:

  • Endocrinology
  • Reproductive Medicine
  • Clinical Chemistry

Background:

  • Establishing accurate trimester-specific reference intervals for thyroid hormones is crucial for managing thyroid dysfunction during pregnancy.
  • Existing guidelines may not fully reflect real-world variations in thyroid-stimulating hormone (TSH) and free thyroxine (FT4) levels.

Purpose of the Study:

  • To establish trimester-specific reference intervals for TSH and FT4 in pregnant individuals using real-world data.
  • To compare these newly established intervals with existing guideline-suggested intervals.

Main Methods:

  • Utilized deidentified pregnancy data including TSH, FT4, and anti-thyroid peroxidase antibody (TPO-Ab) from July 2014 to December 2019.
  • Applied the maximum likelihood method to TPO-Ab-negative pregnancies after data cleaning to determine reference intervals.
  • Included over 55,000 pregnancy records in the analysis.

Main Results:

  • Established trimester-specific reference intervals for TSH (e.g., 0.40-4.09 mIU/L in the first trimester) and FT4 (e.g., 12.2-20.5 pmol/L in the first trimester).
  • Maximum likelihood method-derived FT4 intervals were comparable to guideline intervals, with slight differences in the first and second trimesters.
  • TSH reference intervals calculated using the maximum likelihood method were narrower than those suggested by current guidelines.

Conclusions:

  • Successfully established trimester-specific reference intervals for TSH and FT4 during pregnancy using the maximum likelihood method.
  • The new intervals showed no clinically significant discrepancies for FT4 and narrower limits for TSH compared to existing guidelines.
  • These findings support the use of method-derived intervals for more precise thyroid function assessment in pregnancy.