Download PDF
CC BY-NC-ND 4.0 · J Lab Physicians 2022; 14(02): 183-189
DOI: 10.1055/s-0041-1736520
Original Article

First-Trimester Reference Intervals for Thyroid Function Testing among Women Screened at a Tertiary Care Hospital in India

Rachita Nanda 
1   Department of Biochemistry, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
,
Prasanta Kumar Nayak
2   Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
,
Suprava Patel
1   Department of Biochemistry, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
,
Eli Mohapatra
1   Department of Biochemistry, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
,
Sarita Agrawal
2   Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
› Author Affiliations Funding Statement The authors would like to thank Chhattisgarh Council of Science and Technology for sanctioning grants vide council letter no. 172/CCOST/218.
› Further Information
Also available at
   Permissions and Reprints

Abstract

Objectives Due to differences in the method of assay and population-specific factors, each laboratory needs to establish its own gestation-specific reference intervals (GRIs) for thyroid hormones.

Materials and Methods Three-hundred forty-one women with less than 14 weeks gestation were screened at a tertiary care hospital in Chhattisgarh, India. Serum levels of thyroid-stimulating hormone (TSH), free thyroxine (fT4), and thyroid peroxidase antibody (anti-TPO) were measured using an ADVIA Centaur XP immunoassay.

GRIs (2.5th and 97.5th percentiles) were determined for TSH and fT4. TSH and fT4 concentrations were converted to multiples of the median (MoM) values. Effect of maternal age, gestational age, and maternal weight was analyzed.

Statistical Analysis Quantitative variables were expressed as means and standard deviations (SD), and qualitative variables were expressed as frequencies and percentages. Normality of the data was checked using the Kolmogorov–Smirnov test. Values that were normally distributed were expressed only as means and SD. Those that were not normally distributed were expressed as medians and interquartile range. For all statistical analysis, p < 0.05 was considered as statistically significant.

Results First-trimester GRI was 0.245 to 4.971 mIU/L for TSH, 10.2 to 18.9 pmol/L for fT4, and 27.0 to 56.89 kIU/L for anti-TPO. There was no significant difference in the mean serum TSH (p = 0.920), fT4 (p  = 0.714), or anti-TPO (p = 0.754) values among women in 4 to 7th week and 7 to 14th week of gestation. The 1st and 99th centile MoMs were 0.03 and 4.09 for TSH and 0.66 and 1.39 for fT4. There was a significant positive correlation between the maternal weight and TSH MoM values (p = 0.027, r = 0.120).

Conclusion These laboratory- and first-trimester-specific GRI for TSH and fT4 shall help in proper diagnosis and treatment of subclinical thyroid dysfunctions. TSH and fT4 MoM values can be used to indicate high or low values in a quantitative manner independent of the reference ranges and may be used by other laboratories.

Keywords

thyroid-stimulating hormone - thyroxine - reference range - pregnancy - multiple of median

Authors' Disclosure Statement

No competing financial or personal interest.


Authorship Participation

R.N. was involved in concept and design of work, sample analysis, and wrote first draft of the manuscript. P.K.N. was involved in design of work, acquisition, and analysis of data. S.P. was involved in interpretation of data and drafting of manuscript. E.M. was involved in sample analysis and revising the work critically, and S.A. was involved in acquisition and interpretation of data and revising the work critically. All authors have reviewed and approved of the manuscript prior to submission.


This manuscript has been submitted solely to this journal and is not published in press or submitted elsewhere.


Ethical Approval

Approval taken from Institute Ethics Committee, AIIMS Raipur AIIMSRPR/IEC/2016/019.


Supplementary Material



Publication History

Article published online:
10 November 2021

© 2021. The Indian Association of Laboratory Physicians. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India

 

  • References

  • 1 Laurberg P, Andersen SL, Hindersson P, Nohr EA, Olsen J. Dynamics and predictors of serum TSH and fT4 reference limits in early pregnancy: a study within the Danish National Birth Cohort. J Clin Endocrinol Metab 2016; 101 (06) 2484-2492
    CrossrefPubMedGoogle Scholar
  • 2 Wang G, Zhang G. The diverse upper reference limits of serum thyroid-stimulating hormone on the same platform for pregnant women in China. Lab Med 2020; 51 (04) 416-422
    CrossrefPubMedGoogle Scholar
  • 3 Sun R, Xia J. The reference intervals of thyroid hormones for pregnant women in Zhejiang Province. Lab Med 2017; 49 (01) 5-10
    CrossrefPubMedGoogle Scholar
  • 4 De Groot L, Abalovich M, Alexander EK. et al. Management of thyroid dysfunction during pregnancy and postpartum: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2012; 97 (08) 2543-2565
    CrossrefPubMedGoogle Scholar
  • 5 Lazarus J, Brown RS, Daumerie C, Hubalewska-Dydejczyk A, Negro R, Vaidya B. 2014 European thyroid association guidelines for the management of subclinical hypothyroidism in pregnancy and in children. Eur Thyroid J 2014; 3 (02) 76-94
    CrossrefPubMedGoogle Scholar
  • 6 Stagnaro-Green A, Abalovich M, Alexander E. et al; American Thyroid Association Taskforce on Thyroid Disease During Pregnancy and Postpartum. Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid 2011; 21 (10) 1081-1125
    CrossrefPubMedGoogle Scholar
  • 7 Khadilkar S. Thyroid-stimulating hormone values in pregnancy: cutoff controversy continues?. J Obstet Gynaecol India 2019; 69 (05) 389-394
    CrossrefPubMedGoogle Scholar
  • 8 Korevaar TIM. The upper limit for TSH during pregnancy: why we should stop using fixed limits of 2.5 or 3.0 mU/l. Thyroid Res 2018; 11: 5 DOI: 10.1186/s13044-018-0048-7.
    CrossrefPubMedGoogle Scholar
  • 9 Bestwick JP, John R, Maina A. et al. Thyroid stimulating hormone and free thyroxine in pregnancy: expressing concentrations as multiples of the median (MoMs). Clin Chim Acta 2014; 430: 33-37
    CrossrefPubMedGoogle Scholar
  • 10 Springer D, Jiskra J, Limanova Z, Zima T, Potlukova E. Thyroid in pregnancy: from physiology to screening. Crit Rev Clin Lab Sci 2017; 54 (02) 102-116
    CrossrefPubMedGoogle Scholar
  • 11 Li C, Shan Z, Mao J. et al. Assessment of thyroid function during first-trimester pregnancy: what is the rational upper limit of serum TSH during the first trimester in Chinese pregnant women?. J Clin Endocrinol Metab 2014; 99 (01) 73-79
    CrossrefPubMedGoogle Scholar
  • 12 Hubalewska-Dydejczyk A, Trofimiuk-Müldner M. The development of guidelines for management of thyroid diseases in pregnancy – current status. Thyroid Res 2015; 8 (01) A1-A3
    PubMedGoogle Scholar
  • 13 Alexander EK, Pearce EN, Brent GA. et al. 2017 Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and the postpartum. Thyroid 2017; 27 (03) 315-389
    CrossrefPubMedGoogle Scholar
  • 14 Cunningham FG, Leveno KJ, Bloom SL. et al, Eds. Chapter 9: Prenatal Care. In: Williams Obstetrics. 24th ed.. New York, United States: McGraw-Hill Education; 2014: 167-193
    Google Scholar
  • 15 Kalra S, Agarwal S, Aggarwal R, Ranabir S. Trimester-specific thyroid-stimulating hormone: an Indian perspective. Indian J Endocrinol Metab 2018; 22 (01) 1-4
    CrossrefPubMedGoogle Scholar
  • 16 Medici M, Korevaar TIM, Visser WE, Visser TJ, Peeters RP. Thyroid function in pregnancy: what is normal?. Clin Chem 2015; 61 (05) 704-713
    CrossrefPubMedGoogle Scholar
  • 17 International Council for Control of Iodine Deficiency Disorders, UNICEF, World Health Organization. Assessment of Iodine Deficiency Disorders and Monitoring Their Elimination: A Guide for Programme Managers. Geneva, Switzerland: World Health Organization; 2007
    Google Scholar
  • 18 Korevaar TIM. Levothyroxine overtreatment during pregnancy is associated with a higher risk of adverse child mental health outcomes. Clin Thyroidol 2020; 32 (01) 20-23
    CrossrefGoogle Scholar
  • 19 Rajput R, Singh B, Goel V, Verma A, Seth S, Nanda S. Trimester-specific reference interval for thyroid hormones during pregnancy at a Tertiary Care Hospital in Haryana, India. Indian J Endocrinol Metab 2016; 20 (06) 810-815
    CrossrefPubMedGoogle Scholar
  • 20 Maji R, Nath S, Lahiri S, Saha Das M, Bhattacharyya AR, Das HN. Establishment of trimester-specific reference intervals of serum TSH & fT4 in a pregnant Indian population at North Kolkata. Indian J Clin Biochem 2014; 29 (02) 167-173
    CrossrefPubMedGoogle Scholar
  • 21 Mankar J, Sahasrabuddhe A, Pitale S. Trimester specific ranges for thyroid hormones in normal pregnancy. Thyroid Res Pract 2016; 13 (03) 106-109
    CrossrefGoogle Scholar
  • 22 Pramanik S, Mukhopadhyay P, Bhattacharjee K. et al. Trimester-specific reference intervals for thyroid function parameters in Indian pregnant women during final phase of transition to iodine sufficiency. Indian J Endocrinol Metab 2020; 24 (02) 160-164
    CrossrefPubMedGoogle Scholar
  • 23 Andersen SL, Andersen S, Carlé A. et al. Pregnancy week-specific reference ranges for thyrotropin and free thyroxine in the North Denmark region pregnancy cohort. Thyroid 2019; 29 (03) 430-438
    CrossrefPubMedGoogle Scholar
  • 24 Khalil AB, Salih BT, Chinengo O, Bardies MRD, Turner A, Abdel Wareth LO. Trimester specific reference ranges for serum TSH and free T4 among United Arab Emirates pregnant women. Pract Lab Med 2018; 12: e00098 DOI: 10.1016/j.plabm.2018.e00098.
    CrossrefPubMedGoogle Scholar
  • 25 Kianpour M, Aminorroaya A, Amini M. et al. Reference intervals for thyroid hormones during the first trimester of gestation: a report from an area with a sufficient iodine level. Horm Metab Res 2019; 51 (03) 165-171
    Article in Thieme ConnectPubMedGoogle Scholar
  • 26 Karakosta P, Chatzi L, Bagkeris E. et al. First- and second-trimester reference intervals for thyroid hormones during pregnancy in “rhea” mother-child cohort, Crete, Greece. J Thyroid Res 2011; 2011: 490783 DOI: 10.4061/2011/490783.
    CrossrefPubMedGoogle Scholar
  • 27 Zhang D, Cai K, Wang G. et al. Trimester-specific reference ranges for thyroid hormones in pregnant women. Medicine (Baltimore) 2019; 98 (04) e14245 DOI: 10.1097/MD.0000000000014245.
    CrossrefPubMedGoogle Scholar