Study of thyroid disorders in pregnancy and their effects on feto-maternal outcomes

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Overt and subclinical thyroid dysfunction can lead to adverse effects on both the fetus and the mother. Thyroid diseases during pregnancy affect maternal outcomes and neuropsychological development of the fetus. The objectives of this study were to investigate the effects of thyroid disorders on maternal health and its maternal and perinatal outcomes and to formulate a plan for the management of thyroid disorders in pregnancy. This prospective observational study involved 165 pregnant women. They will be assessed using thyroid function tests, and patients with deranged thyroid function will be treated and followed up. Pregnancy and outcomes were recorded. The findings of this research will offer important new information regarding possible side effects linked to thyroid issues in mothers as well as the clear advantages of therapy. Maternal thyroid diseases have several risk factors in addition to clear advantages of treatment." } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/13-198/v1", "name": "Study of thyroid disorders in pregnancy and their effects on feto-maternal..." } } ] } Home Browse Study of thyroid disorders in pregnancy and their effects on feto-maternal... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Joshi J and Tembhare A. Study of thyroid disorders in pregnancy and their effects on feto-maternal outcomes [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :198 ( https://doi.org/10.12688/f1000research.145416.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Study of thyroid disorders in pregnancy and their effects on feto-maternal outcomes [version 1; peer review: 1 not approved] Jalormy Joshi https://orcid.org/0009-0000-3308-8051 1 , Amardeep Tembhare 1 Jalormy Joshi https://orcid.org/0009-0000-3308-8051 1 , Amardeep Tembhare 1 PUBLISHED 20 Mar 2024 Author details Author details 1 Department of Obstetrics and Gynecology, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442005, India Jalormy Joshi Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Amardeep Tembhare Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Datta Meghe Institute of Higher Education and Research collection. Abstract The second most common endocrine disease that occurs during pregnancy is thyroid disease. Overt and subclinical thyroid dysfunction can lead to adverse effects on both the fetus and the mother. Thyroid diseases during pregnancy affect maternal outcomes and neuropsychological development of the fetus. The objectives of this study were to investigate the effects of thyroid disorders on maternal health and its maternal and perinatal outcomes and to formulate a plan for the management of thyroid disorders in pregnancy. This prospective observational study involved 165 pregnant women. They will be assessed using thyroid function tests, and patients with deranged thyroid function will be treated and followed up. Pregnancy and outcomes were recorded. The findings of this research will offer important new information regarding possible side effects linked to thyroid issues in mothers as well as the clear advantages of therapy. Maternal thyroid diseases have several risk factors in addition to clear advantages of treatment. READ ALL READ LESS Keywords Thyroid disorders, Pregnancy, Maternal outcomes, Fetal outcomes Corresponding Author(s) Jalormy Joshi ( [email protected] ) Close Corresponding author: Jalormy Joshi Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2024 Joshi J and Tembhare A. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Joshi J and Tembhare A. Study of thyroid disorders in pregnancy and their effects on feto-maternal outcomes [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :198 ( https://doi.org/10.12688/f1000research.145416.1 ) First published: 20 Mar 2024, 13 :198 ( https://doi.org/10.12688/f1000research.145416.1 ) Latest published: 20 Mar 2024, 13 :198 ( https://doi.org/10.12688/f1000research.145416.1 ) Introduction The second most prevalent endocrine problem during pregnancy is thyroid abnormalities, which include hypothyroidism, subclinical hypothyroidism, hyperthyroidism, and subclinical hyperthyroidism. 1 During pregnancy, the mother’s thyroid gland undergoes several changes. If a patient is unable to adjust to these changes, her thyroid function becomes erratic. 2 It is well recognized that both overt and subclinical thyroid disorders have negative effects on the growing fetus and expectant mothers. Before or during pregnancy, thyroid disorders can have a variety of effects, including reduced fertility, damage to the trophoblast or embryo, increased risk of miscarriage and stillbirth, higher rates of congenital abnormalities, cretinism, infant mortality, and disruption in psychomotor development. 3 Profound deficiency gives rise to both maternal and fetal hypothyroidism, contributing to adverse obstetric consequences, such as stillbirths, spontaneous abortion, and preterm birth. 4 Maternal thyroid hormones play a vital role in fetal brain development, particularly during the first 20 weeks of gestation. 5 Pregnancy outcomes and cognitive development of the fetus are both greatly affected by thyroid problems. 6 , 7 Prenatal neurodevelopmental problems are caused by anomalies in the thyroid stimulating hormone (TSH) production or elevated serum T4 levels. 7 , 8 During the initial stages of pregnancy, deficiencies in thyroid synthesis (hypothyroidism, subclinical hypothyroidism, and hypothyroxinemia) and the presence of thyroid antibodies are linked to compromised intelligence and motor skills in offspring. Aim We aim to study effects of thyroid disorders on pregnancy and its outcomes. Objectives 1. To study effects of thyroid disorders on maternal health and it’s outcomes. 2. Effect of thyroid in perinatal outcome. 3. To formulate plan of management on thyroid disorders in pregnancy. Protocol Study design An observational study will be conducted in which all pregnant women of less than 20 weeks of gestational age will be presented to the outpatient department, and serum TSH levels will be measured. Pregnant women with deranged TSH levels will be followed-up for delivery, and their maternal and fetal outcomes will be observed. Over the course of two years, the study will be conducted at the Department of Obstetrics and Gynecology at J.N.M.C., AVBRH, D.M.I.H.E.R. (Deemed University), Wardha. Inclusion criteria 1. Pregnant women willing to participate in the study. 2. Pregnant women with abnormal thyroid function test. 3. 3 women willing for follow up till delivery. 4. Singleton pregnancy without any medical or surgical complications. Exclusion criteria 1. Multifetal gestation. 2. Pregnant women with chronic disorders like diabetes, hypertension, liver and renal disorders. 3. Pregnant women not willing for follow up till delivery. Sample size A total of 165 patients were recruited in this study. The following formula was used to determine sample size: Formula used for sample size calculation is, Daniel formula, n = Z α / 2 2 × P × 1 − P d 2 Here, n is the sample size required, Z α/2 is the level of significance at 5%, that is, 95% confidence interval = 1.96. P = Prevalence of thyroid disorders in pregnancy = 12% = 0.12 D = Desired error of margin = 5% = 0.05 Statistical analysis Statistical Method: Chi-square Test Software used: R Studio version 4.3.1 Formula Reference: Daniel et al. Methods Ethical clearance was obtained from the institutional ethics committee. After informed, valid, and written agreement was acquired, each woman was informed about the study’s design and goals, as well as the importance of assessing thyroid function tests in pregnant women and their effects on fetal and maternal outcomes. We submitted applications for intramural grants, synopsis concessions, and ICMR money. A total of 165 pregnant women with deranged TSH levels who met the inclusion and exclusion criteria were observed. Thyroid function tests will be performed before 13 weeks of pregnancy. Pregnant women with a deranged thyroid profile will be followed through birth, and the postpartum period and neonates will be followed until 21 days of life. There will be a thorough review of your menstrual, obstetric, personal, and family histories. A thyroid function test of the neonate was performed on day 4 of life. Venous blood samples will be obtained from the patient to assess the serum TSH, free T3, and free T4 levels. Samples will be taken and allowed to clot in a test tube devoid of anticoagulants. Vital Immuno-Diagnostic Assay System tests were performed on the subjects (VIDAS). If abnormal serum TSH levels were discovered, VIDAS was used to examine the FT3 and FT4 readings. All panel tests were based on the enzyme-linked fluorescent assay (ELFA) method. Outcome We anticipate that there may be negative effects of thyroid abnormalities in mothers in this trial, as well as clear advantages of receiving therapy on time. Dissemination We will aim to publish the study’s output in an indexed journal. Study status The study is not yet started. Discussion The purpose of this study was to assess pregnancy outcomes in women with abnormal thyroid function test results. All women who had been diagnosed with abnormal thyroid function test results started on treatment and were followed up until delivery. 3 Treatment is recommended for pregnant women with overt or subclinical hypothyroidism regardless of the presence of TPO antibodies. Levothyroxine is recommended for both overt and subclinical hypothyroidism, regardless of the presence of TPO antibodies. Early recognition and proper management of thyroid dysfunction in pregnant women are crucial, as poorly controlled thyrotoxicosis substantially amplifies the chances of adverse fetomaternal outcomes. Additionally, maternal thyroid-stimulating antibodies or antithyroid agents pass through the placenta, both of which could potentially disturb fetal thyroid activity, which might affect the fetal outlook. 9 Previous research has indicated a higher prevalence of thyroid issues in younger age groups. These differences could be attributed to demographic shifts such as delayed marriages, delayed pregnancies, and longer gaps between childbirths. Moreover, disparities between urban and rural areas are more pronounced in patients with hypothyroidism. Additionally, a significant number of pregnant women with thyroid disorders have lower levels of education. This factor may contribute to a lack of awareness and disregard for early symptoms, leading to inappropriate healthcare-seeking behaviors and potential complications during pregnancy. 10 It has been observed that many hyperthyroid women tend to have multiple pregnancies. Multiple pregnancies can deplete micronutrients and other essential elements, potentially leading to thyroid dysfunction in multi-gravida women. Furthermore, there are fewer chances of hypothyroid women with spontaneous labor, and they are at a higher risk of undergoing caesarean section. The increasing costs of thyroid profile testing in the private healthcare sector and, in contrast, limited access to laboratories offering these tests in the government sector result in the underdiagnosis of subclinical thyroid dysfunction during its early stages. 11 This underscores the importance of routine screening for thyroid disorders during antenatal checkups in all pregnant individuals. Among individuals with hyperthyroidism, abortion is most common. Hypothyroidism, on the other hand, is associated with low birth weight (LBW) because of its association with conditions such as preeclampsia. Insufficient fetal thyroxine levels can disrupt the development of the newborn’s pituitary-thyroid axis, growth hormone secretion in the fetal pituitary gland, vascular responsiveness and maturation, and cardiovascular balance during fetal development. 11 In addition, a number of problems such as preterm birth, jaundice, respiratory distress syndrome, neonatal sepsis, meconium aspiration syndrome, and birth asphyxia can occur in newborns born to women with thyroid abnormalities. 11 Ethical considerations Informed, valid and written consent will be taken from all our participants who are included in the study. Approval from the Institutional Ethics Committee has been issued, dated 21/07/2022. The Reference number was DMIMS (DU)/IEC/2022/112. Data availability statement Currently no data is associated with this article as this is a study protocol. Reporting guidelines Zenodo: SPRIT checklist for ‘Study of thyroid disorders in pregnancy and their effects on feto-maternal outcomes’, DOI: 10.5281/zenodo.10685225 . Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). References 1. Khan I, Okosieme OE, Lazarus JH: Current challenges in the pharmacological management of thyroid dysfunction in pregnancy. Expert. Rev. Clin. Pharmacol. 2017 Jan; 10 (1): 97–109. Epub 2016 Nov 8. PubMed Abstract | Publisher Full Text 2. Allan WC, Haddow JE, Palomaki GE, et al. : Maternal thyroid deficiency and pregnancy complications: implications for population screening. J. Med. Screen. 2000; 7 (3): 127–130. PubMed Abstract | Publisher Full Text 3. Ghirri P, Lunardi S, Boldrini A: Iodine supplementation in the newborn. Nutrients. 2014 Jan 20; 6 (1): 382–390. PubMed Abstract | Publisher Full Text | Free Full Text 4. WHO: Assessment of iodine deficiency disorders and monitoring their elimination: a guide for programme managers. Geneva: WHO; 2007. 5. Pu-Yu S, Huang K, Hao J-H, et al. : Maternal Thyroid Function in the First Twenty Weeks of Pregnancy and Subsequent Fetal and Infant Development: A Prospective Population-Based Cohort Study in China. J. Clin. Endocrinol. Metabol. 1 October 2011; 96 (10): 3234–3241. PubMed Abstract | Publisher Full Text 6. Zhou M, Wang M, Li J, et al. : Effects of thyroid diseases on pregnancy outcomes. Exp. Ther. Med. July 5, 2019; 18 : 1807–1815. PubMed Abstract | Publisher Full Text | Free Full Text 7. Noten AME, Loomans EM, Vrijkotte TGM, et al. : Maternal hypothyroxinaemia in early pregnancy and school performance in 5-year-old offspring. Eur. J. Endocrinol. Nov 2015; 173 (5): 563–571. PubMed Abstract | Publisher Full Text 8. Williams FLR, Watson J, Ogston SA, et al. : Maternal and Umbilical Cord Levels of T 4 , FT 4 , TSH, TPOAb, and TgAb in Term Infants and Neurodevelopmental Outcome at 5.5 Years. J. Clin. Endocrinol. Metabol. 1 February 2013; 98 (2): 829–838. PubMed Abstract | Publisher Full Text 9. Moleti M, DiMauro M, Sturniolo G, et al. : Hyperthyroidism in the pregnant woman: Maternal and fetal aspects. J. Clin. Transl. Endocrinol. 2019 June; 16 : 100190. PubMed Abstract | Publisher Full Text | , Free Full Text 10. Vaidya B, Anthony S, Bilous M, et al. : Detection of Thyroid Dysfunction in Early Pregnancy: Universal Screening or Targeted High-Risk Case Finding? J. Clin. Endocrinol. Metabol. January 2007; 92 (1): 203–207. Publisher Full Text 11. Kumar R, Bansal R, Shergill HK, et al. : Prevalence of thyroid dysfunction in pregnancy and its association with feto-maternal outcomes: A prospective observational study from a tertiary care institute in Northern India. Clin. Epidemiol. Glob. Health. December 11, 2022; 19 : 101201. Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 20 Mar 2024 ADD YOUR COMMENT Comment Author details Author details 1 Department of Obstetrics and Gynecology, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442005, India Jalormy Joshi Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Amardeep Tembhare Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 20 Mar 2024, 13:198 https://doi.org/10.12688/f1000research.145416.1 Copyright © 2024 Joshi J and Tembhare A. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Joshi J and Tembhare A. Study of thyroid disorders in pregnancy and their effects on feto-maternal outcomes [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :198 ( https://doi.org/10.12688/f1000research.145416.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 20 Mar 2024 Views 0 Cite How to cite this report: Riedel CA. Reviewer Report For: Study of thyroid disorders in pregnancy and their effects on feto-maternal outcomes [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :198 ( https://doi.org/10.5256/f1000research.159364.r280112 ) The direct URL for this report is: https://f1000research.com/articles/13-198/v1#referee-response-280112 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 16 Sep 2024 Claudia A Riedel , Universidad Andrés Bello, Santiago, Chile Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.159364.r280112 The objective of this work is to analyze thyroid diseases in 165 pregnant women who have altered TSH. Follow them during pregnancy and then see the outcome of the neonate until day 21st. My main concern is with the strategy ... Continue reading READ ALL The objective of this work is to analyze thyroid diseases in 165 pregnant women who have altered TSH. Follow them during pregnancy and then see the outcome of the neonate until day 21st. My main concern is with the strategy because the authors will include pregnant women if TSH is altered outside the normal range. However, they do not consider those women who have normal TSH and low T4. It is very well known that this condition, named hypothyroxinemia, is harmful to fetus development. My other concern is regarding the description in the methodology of which parameters they will look in the offspring. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? No Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Yes References 1. Pop VJM, Krabbe JG, Broeren M, Wiersinga W, et al.: Hypothyroxinaemia during gestation is associated with low ferritin and increased levels of inflammatory markers. Eur Thyroid J . 2024; 13 (2). PubMed Abstract | Publisher Full Text Competing Interests: No competing interests were disclosed. Reviewer Expertise: gestational hypothyroxinemia I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Riedel CA. Reviewer Report For: Study of thyroid disorders in pregnancy and their effects on feto-maternal outcomes [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :198 ( https://doi.org/10.5256/f1000research.159364.r280112 ) The direct URL for this report is: https://f1000research.com/articles/13-198/v1#referee-response-280112 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 20 Mar 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 1 20 Mar 24 read Claudia A Riedel , Universidad Andrés Bello, Santiago, Chile Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Riedel C. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 16 Sep 2024 | for Version 1 Claudia A Riedel , Universidad Andrés Bello, Santiago, Chile 0 Views copyright © 2024 Riedel C. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The objective of this work is to analyze thyroid diseases in 165 pregnant women who have altered TSH. Follow them during pregnancy and then see the outcome of the neonate until day 21st. My main concern is with the strategy because the authors will include pregnant women if TSH is altered outside the normal range. However, they do not consider those women who have normal TSH and low T4. It is very well known that this condition, named hypothyroxinemia, is harmful to fetus development. My other concern is regarding the description in the methodology of which parameters they will look in the offspring. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? No Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Yes References 1. Pop VJM, Krabbe JG, Broeren M, Wiersinga W, et al.: Hypothyroxinaemia during gestation is associated with low ferritin and increased levels of inflammatory markers. Eur Thyroid J . 2024; 13 (2). PubMed Abstract | Publisher Full Text Competing Interests No competing interests were disclosed. Reviewer Expertise gestational hypothyroxinemia I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (0) Riedel CA. Peer Review Report For: Study of thyroid disorders in pregnancy and their effects on feto-maternal outcomes [version 1; peer review: 1 not approved] . F1000Research 2024, 13 :198 ( https://doi.org/10.5256/f1000research.159364.r280112) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/13-198/v1#referee-response-280112 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Adjust parameters to alter display View on desktop for interactive features Includes Interactive Elements View on desktop for interactive features Competing Interests Policy Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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