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Study Protocol

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

[version 1; peer review: 1 not approved]
PUBLISHED 20 Mar 2024
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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.

Keywords

Thyroid disorders, Pregnancy, Maternal outcomes, Fetal outcomes

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=Zα/22×P×1Pd2

Here, n is the sample size required,

Zα/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.

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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.
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Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe 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 approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 20 Mar 2024
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Reviewer Report 16 Sep 2024
Claudia A Riedel, Universidad Andrés Bello, Santiago, Chile 
Not Approved
VIEWS 8
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
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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)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 20 Mar 2024
Comment
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
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