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Prevalence of hypothyroidism among pregnant women and associated feto-maternal outcomes in India: Systematic review and meta-analysis
For correspondence: Dr Tanica Lyngdoh, Department of Reproductive, Child Health and Nutrition, Indian Council of Medical Research, Delhi 110 029, India e-mail: tanica.lyngdoh@gmail.com
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Received: ,
Accepted: ,
How to cite this article: Manna S, Mukherjee R, Kandpal V, Zode M, Kulkarni B, Lyngdoh T. Prevalence of hypothyroidism among pregnant women and associated feto-maternal outcomes in India: Systematic review and meta-analysis. Indian J Med Res. 2026;163:745-62. doi: 10.25259/IJMR_2554_2025
Abstract
Background and objectives
Hypothyroidism is the most common thyroid disorder during pregnancy and, if not managed adequately, increases the risk of adverse foeto-maternal outcomes. The present systematic review and meta-analysis was conducted to assess the prevalence of hypothyroidism among Indian pregnant women and related foeto-maternal outcomes.
Methods
A systematic search was conducted across PubMed, Google Scholar, and preprint servers to identify observational studies reporting the prevalence of hypothyroidism and associated foeto-maternal outcomes among Indian pregnant women. A random-effects model was utilised to pool effect sizes, and heterogeneity was assessed using I2 statistic. Funnel plots, along with Begg’s and Egger’s tests, were used to assess publication bias. Data were analysed using STATA version 17.
Results
A total of 60 studies were included. The pooled prevalence of hypothyroidism among pregnant women was 17% [95% confidence interval (CI): 14%, 19%] with subclinical hypothyroidism at 15% (95% CI: 12%, 18%) and overt hypothyroidism at 3% (95% CI: 3%, 4%). In women with subclinical hypothyroidism, the pooled prevalence of adverse maternal outcomes was 9% (95% CI: 6%, 11%), while the prevalence of adverse foetal outcomes was 11% (95% CI: 9%, 14%). The pooled prevalence was 18% for preterm birth (95% CI: 11%, 25%), 17% for low birth weight (95% CI: 10%, 25%), 7% for intrauterine death (95% CI: 2, 14%), and 2% for stillbirth (95% CI: 0, 4%). Among women with overt hypothyroidism, the prevalence of adverse maternal and foetal outcomes was 12% (95% CI: 10%, 15%) and 14% (95% CI: 11%, 17%), respectively. The pooled prevalence was 22% for low birth weight (95% CI: 13%, 31%), 16% for preterm birth (95% CI: 9%, 24%), 16% for intrauterine death (95% CI: 7%, 27%), and 6% for stillbirth (95% CI: 1%, 13%). Most studies used trimester-specific TSH cut-offs based on the American Thyroid Association guidelines. One fourth (n=15) of the 60 studies applied alternative thresholds, with upper limits for normal TSH varying from 4.0-10.0 mIU/L.
Interpretation and conclusions
The rising burden and adverse consequences of hypothyroidism in pregnancy demand urgent attention. Uniform, evidence-based screening and management practices must be implemented at all levels of care. There is a pressing need for India-specific diagnostic cut-offs and large-scale prospective studies to inform treatment thresholds and long-term outcomes.
Keywords
Adverse effect
Hypothyroidism
India
Neonatal outcomes
Pregnant women
Prevalence
Pregnancy outcomes
Globally, the prevalence estimates of hypothyroidism during pregnancy vary considerably.1-5 In India, studies report a wide range of prevalence estimates for maternal hypothyroidism.6 A 2021 meta-analysis of 61 studies in pregnant women estimated an overall prevalence of hypothyroidism as 11.1%, 9.5% subclinical, and 2.7% overt hypothyroidism.6 A population-based cohort in North India reported that nearly 29% of pregnant women in early pregnancy had hypothyroidism, with higher susceptibility among those with anaemia or overweight.7
Untreated or inadequately managed hypothyroidism in pregnancy can have far-reaching consequences, including miscarriage, preeclampsia, and placental complications in the mother as well as preterm birth, low birth weight and impaired neurodevelopment in the child.8-12 Emerging evidence suggests that hypothyroidism in pregnancy is shaped not only by iodine deficiency but also by a complex interplay of nutritional factors, environmental exposures, metabolic conditions, and autoimmune processes.13-17 This multifactorial etiology highlights the need for a deeper understanding of risk pathways and outcomes, especially among Indian women.
While previous research has explored the burden of hypothyroidism in pregnancy, a focused synthesis of the prevalence of associated complications remains lacking in the Indian context. We could not find any review on adverse maternal and foetal outcomes in this population. The present study aims to conduct a meta-analysis to estimate the prevalence of hypothyroidism and its associated adverse outcomes, thereby providing evidence to support the implementation of screening protocols.
Methods
Search strategy
A systematic literature search was conducted across PubMed, Google Scholar, and manual searching in preprint servers. All studies published up to January 2025 were considered, regardless of study type or language. A forward and backward citation techniques were applied to ensure comprehensive inclusion of the relevant literature.
Separate search strategies were developed for each database (Supplementary Table I). The search strategy included a combination of keywords and Medical Subject Headings (MeSH) terms like: ‘thyroid’, ‘hypothyroidism’, ‘thyroid disorder’, ‘pregnancy’, ‘pregnant women’, ‘antenatal’, ‘prenatal’, ‘prevalence’, ‘burden’, ‘incidence’, ‘adverse effects’, ‘birth outcome’, ‘side effects’, ‘maternal outcome’, ‘foetal outcome’, among others. Boolean operators (AND/OR) and database-specific syntax were applied to construct a robust and comprehensive search strategy. This review was registered with Open Science Framework (OSF) [ https://doi.org/10.17605/OSF.IO/PQJX2 ].
Selection criteria
Studies were included if they - (i) enrolled pregnant women screened and diagnosed with hypothyroidism at the first antenatal visit, irrespective of the trimester, (ii) were conducted in community/hospital (cross-sectional, cohort studies were considered eligible where thyroid function was assessed at baseline or first antenatal visit), (iii) reported prevalence of hypothyroidism (overt, subclinical, or overall), (iv) reported prevalence of adverse foeto-maternal outcomes among pregnant hypothyroid women, (v) India-specific studies, (vi) diagnosis based on TSH level, (vii) studies published in English and with full-text availability.
Case-control studies, experimental studies, ecological reports, case reports, case series, editorials and protocols were excluded.
Screening and data extraction
Two reviewers independently searched all databases and duplicate records were removed. The de-duplicated set of records was subsequently imported into Rayyan, a web-based tool designed to facilitate an organised and transparent screening process for systematic reviews.18 Two reviewers (VK and SM) independently screened titles and abstracts, followed by full-text screening of potentially eligible articles. Any disagreements during the screening process were resolved through discussion and, when necessary, by consultation with a third reviewer (MZ). Similarly, data extraction was conducted independently by SM and VK, with discrepancies resolved by consensus or by involving the third reviewer (MZ). Information regarding author, year of publication, study setting (community/hospital-based), study location, definition and diagnostic criteria of hypothyroidism, sample size, prevalence, and maternal and foetal adverse outcomes. A data extraction table was prepared in Microsoft Excel for further analysis. Articles searched were reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)19 statement and reporting guidelines to ensure scientific precision.
Quality assessment
We assessed the quality of the included cross-sectional and cohort studies using the Joanna Briggs Institute (JBI) scale. A separate checklist was adopted for cohort, descriptive, and analytical cross-sectional study designs.20,21 The following factors were assessed by this tool: the clarity of the inclusion criteria, the suitability of the recruitment and sampling strategies, the validity and reliability of the study tool, the adequacy of the sample size, the detailed description of the study subjects, the data analysis with adequate coverage of the identified sample, the use of valid methods for condition identification, the measurement of the condition consistently and reliably for all participants, the use of appropriate statistical analysis, and the adequacy of the response rate. Every item on the checklist received a rating of ‘Yes,’ ‘No,’ ‘Unclear,’ or ‘Not Applicable,’ and each study was given an overall quality rating.
We rated ‘Yes’ as ‘1’ and rest of the options as ‘0’. Two reviewers independently carried out the appraisal, and any disagreements were settled by discussion or, if necessary, consultation with a third reviewer.
The results of the quality assessment were used to interpret the strength of the evidence and, when appropriate, were further investigated through sensitivity analysis. Studies were not eliminated based only on quality scores.
Data synthesis and management
The prevalence of hypothyroidism was calculated by dividing the number of pregnant women with hypothyroidism by the total study participants. The effect size of each of the studies was calculated by prevalence estimates of overall hypothyroidism, Subclinical and overt hypothyroidism in pregnant women in the included studies. Pooled prevalence of maternal and foetal adverse outcomes was also reported separately for hypothyroidism, subclinical and overt. The random-effects model with restricted maximum likelihood (REML) estimation was used to pool prevalence estimates. In addition, Freeman-Tukey (double arcsine) transformation for proportions was applied to stabilise the variances. Heterogeneity of the studies was estimated using the I2 statistic and interpreted based on commonly used thresholds: values below 25% were considered to indicate low heterogeneity, 25-50% moderate, and values above 50% substantial heterogeneity. Sensitivity analysis was performed excluding low-quality (<5) studies. Meta-regression was performed to explore the influence of study-level covariates on pooled estimates. Funnel plots and Begg and Egger’s tests were performed to evaluate publication bias. Estimates were reported as a proportion with a 95% confidence interval. P value <0.05 was considered statistically significant. All analyses were performed using STATA v17.0 using ‘Metaprop’ and ‘meta’ commands.
Results
We identified 959 articles from PubMed, Google Scholar, and the Cochrane database. After removal of duplicates total of 731 studies were screened for title and abstract, 533 studies were assessed for eligibility, of which 60 studies met our inclusion criteria and were included in the study. The summarisation of search results was presented using a PRISMA flow diagram19 ( Fig. 1).

Of these, 34 studies were based on population-based cohorts, and 26 were cross-sectional. Of the 60 studies,7,22-80 53 studies reported the prevalence of overall hypothyroidism, 47 reported the prevalence of subclinical (n=44, 342), and 42 reported the prevalence of overt hypothyroidism (n=42,360) among pregnant women. The majority of the studies were hospital-based; only one study was community-based ( Table)7,22-80.
| Sr. No. | Author and Year | Sample size | Settings | State | Trimester | Definition | Method | Outcomes reported | Quality score |
|---|---|---|---|---|---|---|---|---|---|
| 1 | Marwaha et al22, 2008 | 541 | Hospital based | New Delhi | Any | TSH (0.27–4.2 mIU/ml); FT3 (3.7–7.2 pM/l), FT4 (12.0–23.0 pM/l); Definition for SCH and OH not specified. Trimester-specific reference values not specified. | Electro-chemiluminescent immunoassay | Prevalence of hypothyroidism, OH and SCH | 8 |
| 2 | Sahu et al23, 2010 | 633 | Hospital based | Uttar Pradesh and New Delhi | Second | The normal range for TSH is 0.5–5.5 mIU/L. TSH>5.5 mIU/L or <0.5 mIU/L were considered abnormal. OH if high TSH with low-free T4; SCH if high TSH in the presence of normal blood levels of thyroid hormone | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes in OH and SCH | 8 |
| 3 | Nambiar et al24, 2011 | 483 | Hospital based | Maharashtra | First | The normal range for TSH (0.4–4), FT3: (0.23–0.63), FT4 (10.3–24.45) | Chemiluminescence Immunoassay | Prevalence of hypothyroidism and fetomaternal outcomes (no classification between SCH or OH) | 9 |
| 4 | Dhanwal et al25, 2013 | 1000 | Hospital based | New Delhi | First | Hypothyroidism if TSH > 4.5 mIU/L; SCH if TSH >4.5 mIU/L and normal free T4; OH if TSH >4.5 mIU/L and low free T4 | ELISA | Prevalence of hypothyroidism, OH and SCH | 8 |
| 5 | Konin et al26, 2013 | 400 | Hospital based | Karnataka | First | Normal reference values for TSH (0.4-4.2 uIU/ml), FT3 (2.0-3.8pg/ml), FT4 (0.80-2.70ng/dl); Definition for SCH not specified. | Not specified | Prevalence of hypothyroidism and SCH | 7 |
| 6 | Ajmani et al27, 2014 | 400 | Hospital based | Karnataka | Second | As per ATA 2011; SCH if TSH >3.0 µIU/l and normal Free T4 (0.8–2.0 ng/dl); OH if TSH >3.0 µIU/l with low Free T4 (<0.8 ng/dl) First trimester, 0.1–2.5 µIU/ml; second trimester, 0.2–3.0 µIU/ml; and third trimester, 0.3–3.0 µIU/ ml | ELISA | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes in OH and SCH | 7 |
| 7 | Jaiswal et al28, 2014 | 334 | Hospital based | Karnataka | First | Hypothyroidism if TSH >2.5 mIU/L for the first trimester; normal reference range for free T4 (0.89–1.76 ng/dL); OH if high TSH with low-free T4; SCH if high TSH with normal free T4 | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH | 8 |
| 8 | Nabhi et al29, 2014 | 322 | Hospital based | Telangana | Second | As per ATA 2011; SCH if TSH>3.0 mIU/L, normal T4 and T3; OH if TSH >3.0 mIU/L and T4<10 mcg/dl1st trimester: 0.1 to 2.5 m IU/L, 2nd trimester: 0.2 to 3.0m IU/L, and 3rd trimester: 0.3 to 3.0 mIU/L. | Not specified | Prevalence of hypothyroidism, OH and SCH | 8 |
| 9 | Rupali M et al30, 2014 | 800 | Hospital based | West Bengal | Third | Normal range for TSH (0.2-3.0 miu/l). SCH if TSH >3 miu/l with normal level of free T4 (0.8-2ng/dl). | Chemiluminescent enzyme immunometric assay | Prevalence of SCH and fetomaternal outcomes in SCH | 7 |
| 10 | Bose et al31, 2015 | 1152 | Hospital based | Madhya Pradesh | First | Hypothyroidism, if TSH >2.5 mIU/ml; SCH if TSH >2.5 mIU/ml and normal Free T4 (normal range 0.7–1.48 ng/dl); OH if TSH >2.5 mIU/ml with low Free T4 | Chemiluminescent Microparticle Immunoassay (CMIA) | Prevalence of hypothyroidism, OH and SCH | 8 |
| 11 | Kishore et al32, 2015 | 263 | Hospital based | Chhattisgarh | First | OH if TSH >2.5 IU/L with a decreased FT4 or TSH levels ≥10.0 mIU/L; SCH if TSH between 2.5 and 10mIU/L with a normal FT4 | ELISA | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes in OH and SCH | 8 |
| 12 | Murty et al33, 2015 | 1340 | Hospital based | Telangana | Any | As per ATA 2011; SCH if TSH>3.0 mIU/L and normal T4 and T3, OH if TSH >3.0 mIU/L and T4 <7.5 mcg/dl1st trimester - 0.1 to 2.5 mIU/L, 2nd trimester - 0.2 to 3.0 mIU/L and 3 rd trimester - 0.3 to 3.0 mIU/L | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH | 8 |
| 13 | Padmavathi et al34, 2015 | 1000 | Hospital based | Andhra Pradesh | First | The normal range for TSH: First trimester (0.03-2.3 µIU/ml); second (0.03-3.7 µIU/ml) and third (0.13 - 3.4 µIU/ ml)The normal range for FT4: First trimester (0.86-1.77 ng/dl), second (0.63-1.39 ng/dl); and third (0.16-1.12 ng/dl)Definition for SCH and OH not specified. | Chemiluminescent Microparticle Immunoassay (CMIA) | Prevalence of hypothyroidism | 4 |
| 14 | Pavanaganga et al35, 2015 | 1663 | Hospital based | Karnataka | Any | As per ATA 2011 and ES 2012 SCH if TSH >2.5mIU in first trimester, >3mIU in second and third trimester with normal free T3 and T4 levels; OH if TSH >10mIU/l with low free T3 and T4 levels. | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH, and maternal outcomes in OH and SCH | 6 |
| 15 | Rajput et al36, 2015 | 461 | Hospital based | Haryana | First | The normal range for TSH (0.35–5.5 mIU/L), FT3 (2.3–4.2 pg/mL), FT4 (0.89–1.76 ng/dL)Trimester-specific cut-off values for TSH, first (0.1–2.5 mIU/L), second (0.2–3.0 mIU/L) and third (0.3–3.0 mIU/L)OH if TSH>2.5 mIU/L and FT3, FT4 below the reference range; SCH if TSH>2.5 mIU/Land FT3, FT4 in the normal range | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH | 8 |
| 16 | Singh et al37, 2015 | 400 | Hospital based | Manipur | First and Second | As per ATA 2011; Normal range for TSH: first trimester (0.1-2.5 mlu/L) and second (0.3-3 mlu/L) SCH if TSH > 3 mlu/L with normal FT4; OH if TSH > 3 mlu/L with FT4 < 7.5 mcg/dl | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH | 8 |
| 17 | Begum et al38, 2016 | 9117 | Hospital based | Assam | Any | Hypothyroidism if TSH > 3.0 mU/L; Definition for SCH and OH not specified. Trimester-specific reference values not specified. | Vitros 5600 | Prevalence of hypothyroidism and fetomaternal outcomes (no classification between SCH or OH) | 7 |
| 18 | Dhanwal et al39, 2016 | 2955 | Hospital based | New Delhi | Any | As per ATA 2011; The normal range for TSH: first trimester (<2.5 mIU/L) and second and third (<3.0 mIU/L) | Electro-chemiluminescent immunoassay | Prevalence of hypothyroidism | 8 |
| 19 | Mandal et al40, 2016 | 510 | Hospital based | West Bengal | First | Normal range for TSH (0.1-2.5 μIU/mL) and FT4 (0.8-1.7 ng/dl)SCH if TSH >2.5 μIU/mL and normal FT4; OH if TSH>10 μIU/mL and FT4 less than normal | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH | 7 |
| 20 | Saraladevi et al41, 2016 | 1000 | Hospital based | Telangana | First | The normal range for TSH: first trimester (0.1 to 2.5 m IU/L), second (0.2 to 3.0 mIU/L) and third (0.3 to 3.0 mIU/L)SCH if high TSH level with normal fT4, fT3 level; OH if high TSH level with fT4 and fT3 less than normal range | Not specified | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes in OH and SCH | 5 |
| 21 | Shivanagappa et al42, 2016 | 999 | Hospital based | Karnataka | Any | Hypothyroidism if TSH >3μIU/ml; Definition for SCH and OH not specified. Trimester-specific reference values not specified. | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH, and foetal outcomes among OH and SCH | 6 |
| 22 | Singh et al43, 2016 | Hospital based | Jammu | Any | Normal ranges for TSH (0.5 to 5 mU/L), T3 (0.8 to 1.6 ng/mL or 80 to 160 ng/dL) and T4 (60 to 120 ng/mL or 6 to 12 µg/dL) | Radioimmunoassay | Prevalence of OH and SCH and fetomaternal outcomes in SCH | 4 | |
| 23 | Tiwari et al44, 2016 | Hospital based | New Delhi | Any | Normal range for TSH (0.3–6.2 mIU/L) and free T4 (0.76-2.24 ng/dL).Hypothyroidism if TSH >6.2 mIU/L; OH if elevated TSH with low free T4; SCH if elevated TSH with normal FT4. | ELISA | Fetomaternal outcomes among hypothyroid pregnant women (no classification between SCH or OH) | 6 | |
| 24 | Dubey et al45, 2017 | 200 | Hospital based | Sikkim | First and Second | As per ATA 2011; The normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l) | Not specified | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes (no classification between SCH or OH) | 7 |
| 25 | Gedam et al46, 2017 | 350 | Hospital based | Maharashtra | Any | The normal range for TSH (0.35-5.5 mIU/l), Free T3 (1.7-4.2 pg/ml), and Free T4 (0.7-1.8 ng/dl)The normal range for TSH: First trimester (0.1-2.5mIU/L) Second (0.2-3mIU/), Third (0.3-3 mIU/L)OH if elevated TSH with low FreeT3, FreeT4; SCH if TSH >2.5mIU/L with FreeT3, FreeT4 in normal range. | Not specified | Prevalence of hypothyroidism, OH and SCH | 8 |
| 26 | Indira et al47, 2017 | 333 | Hospital based | Andhra Pradesh | Any | As per ATA 2011; First trimester (0.1-2.5 mIU/L), second (0.2-3.0 mIU/L), and third (0.3-3 mIU/L); free T4 (0.7-1.8 ng/mL) and free T3 level (1.7-4.2 pg/mL)SCH if elevated TSH with normal free T3 and T4 levels; OH if elevated TSH with free T3 and T4 less than normal range. | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH | 7 |
| 27 | Pokhanna et al48, 2017 | 300 | Hospital based | Madhya Pradesh | Second | As per ATA 2011; First trimester (0.1-2.5 mIU/L), second (0.2-3.0 mIU/L), and third (0.3-3 mIU/L) | Direct immunoassay | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes in OH and SCH | 7 |
| 28 | Sannaboraiah et al49, 2017 | 200 | Hospital based | Karnataka | Any | As per European Thyroid Association Guidelines 2014 SCH if TSH >2.5mIU/L in the first trimester, >3mIU/L and >3.5mIU/L in the second and third trimester, respectively, provided normal free T3 and T4 | Not specified | Prevalence of hypothyroidism and SCH, and feto-maternal outcomes in SCH | 6 |
| 29 | Usha Devi et al50, 2017 | 1000 | Hospital based | Andhra Pradesh | First | No reference ranges specified | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes in OH and SCH | 6 |
| 30 | Bansal et al51, 2018 | 101 | Hospital based | Uttar Pradesh | Any | The normal range for TSH: first trimester (0.1-2.5mIU/l), second (0.2-3mIU/l), third (0.3-3mIU/l) | Not specified | Prevalence of hypothyroidism, OH and SCH | 2 |
| 31 | Gupta et al52, 2018 | 1268 | Hospital based | Maharashtra | Any | As per ATA 2011; The normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l). | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes in OH and SCH | 8 |
| 32 | Hymavathi et al53, 2018 | 1000 | Hospital based | Andhra Pradesh | Any | No reference ranges specified. | Not specified | Prevalence of hypothyroidism, OH and SCH | 4 |
| 33 | Korde et al54, 2018 | 705 | Hospital based | Maharashtra | First | ACOG guidelines 2015The normal range for TSH: first trimester: 0.1-2.5 µIU/ml, second (0.2-3.0 µIU/ml), third (0.3-3.0 µIU/ml)The normal range for T3 (60-200 ng/dl) and T4 (4.5-12 µgm/dl) | Not specified | Prevalence of hypothyroidism, OH and SCH | 7 |
| 34 | Kumari et al55, 2018a | 720 | Hospital based | Uttar Pradesh | First and Second | As per ATA 2011; The normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l).SCH if elevated TSH with normal fT3 and fT4 levels; OH if elevated TSH with free T3 and T4 levels less than the normal range. | Not specified | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes in OH and SCH | 5 |
| 35 | Kumari et al56, 2018b | 4701 | Hospital based | Andhra Pradesh | Any | As per ATA 2011; The normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l). | Not specified | Prevalence of hypothyroidism, OH and SCH | 7 |
| 36 | Pahwa et al57, 2018 | 100 | Hospital based | Punjab | First | The normal range for TSH: First trimester (0.1-2.5mIU/L) Second (0.2-3mIU/), Third (0.3-3 mIU/L)The normal range for free T3 (1.7-4.2pg/ml) and free T4 (0.7-1.8ng/dl) | Not specified | Prevalence of hypothyroidism, OH and SCH | 5 |
| 37 | Panda et al58, 2018 | 428 | Hospital based | Odisha | Any | As per ATA 2011; Normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l).OH if elevated TSH with FT4 below the reference range or TSH ≥10 mIU/L irrespective of the FT4 level; SCH if TSH between 2.5 mIU/L and 10 mIU/L with FT4 in the normal range | Electro-chemiluminescent immunoassay | Prevalence of hypothyroidism, OH and SCH | 7 |
| 38 | Pillai et al59, 2018 | 1000 | Hospital based | Kerela | First | Normal range for TSH: first trimester (0.1-2.5mIU/L).OH if TSH >10mIU/L or elevated TSH with a low free T4; SCH if elevated TSH with a normal free T4 | Not specified | Prevalence of hypothyroidism, OH and SCH | 9 |
| 39 | Agarwal et al60, 2019 | 250 | Hospital based | New Delhi | First | Hypothyroidism if TSH >4.5mIU/L; OH if free T4 level <8.5 pmol/L; SCH if free T4 level >8.5pmol/L | ELISA | Prevalence of hypothyroidism | 6 |
| 40 | Diyora et al61, 2019 | 200 | Hospital based | Gujarat | First | Normal range for TSH (0.4-2.5 mU/l), T3 (0.5-2.0 ng/ml), and T4 (53-121 ng/ml).OH if elevated TSH with T3, T4 below the reference range; SCH if elevated TSH with normal T3, T4 | ELISA | Prevalence of hypothyroidism, OH and SCH | 8 |
| 41 | Sharma et al62, 2019 | 120 | Hospital based | Uttarakhand | Any | Normal range for TSH (0.465-5.68 mIU/ml) and free T4 (10.0-28.2 pmol/L)SCH if elevated TSH and normal Free T4; OH if elevated TSH and decreased free T4 | Immunometric assay ECi. | Prevalence of hypothyroidism and fetomaternal outcomes (no classification between SCH or OH) | 6 |
| 42 | Justin et al63, 2020 | 1500 | Hospital based | Kerela | First and Second | As per ATA 2011; Normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l). | Not specified | Prevalence of hypothyroidism and fetomaternal outcomes (no classification between SCH or OH) | 7 |
| 43 | Mahadik et al64, 2020 | 198 | Hospital based | Madhya Pradesh | Third | As per ATA 2017; Normal range for TSH: first trimester (0.1-4.0mIU/L), second (0.2-4.5mIU/L), third (0.3-5mIU/L). Normal free T4 (0.7 to 1.8 ng/dl) and free T3 (1.7 to 4.2 pg/ml)OH if high TSH with low free T4; SCH if high TSH with normal free T4 | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes (no classification between SCH or OH) | 6 |
| 44 | Mahajan et al65, 2020 | 514 | Hospital based | Maharashtra | Second | As per ATA 2011; The normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l). | Enzyme Linked Fluorescent Assay | Prevalence of hypothyroidism, OH and SCH, and maternal outcomes in OH and SCH | 6 |
| 45 | Ramachandra et al66, 2020 | 451 | Hospital based | Kerela | First and Second | SCH if high TSH and normal free T4; OH if high TSH and low free T4 | Not specified | Prevalence of hypothyroidism, OH and SCH | 5 |
| 46 | Gupta et al67, 2021 | 865 | Hospital based | Madhya Pradesh | First | As per ATA 2017: Normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l).SCH if elevated TSH with normal free T3 and T4 levels; OH if elevated TSH with free T3 and T4 levels less than the normal range. | Not specified | Prevalence of hypothyroidism, OH and SCH | 5 |
| 47 | Savitha et al68, 2021 | 491 | Hospital based | Karnataka | First | As per ATA and National Guidelines, India (2014);SCH if TSH value>2.5 µIU/ml but ≤10 µIU/ml with normal T4; OH if TSH value>10 µIU/ml irrespective of T4 values and TSH value >2.5 µIU/ml with low T4 | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH | 8 |
| 48 | Dash et al69, 2022 | 382 | Hospital based | Odisha | Any | As per ATA 2011; The normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l).SCH if TSH levels higher than the trimester specific level and normal free T4 levels | Chemiluminescence Immunoassay | Prevalence of SCH | 4 |
| 49 | Ashwini et al70, 2023 | 2017 | Hospital based | Tamil Nadu | First | SCH if TSH between 2.5 and 10 mIU/l with normal free T4; OH if TSH >3 mIU/l with low free T4 levels or TSH >10 mIU/l irrespective of free T4 | Not specified | Prevalence of hypothyroidism and fetomaternal outcomes (no classification between SCH or OH) | 7 |
| 50 | Bankapur et al71, 2023 | 427 | Hospital based | Karnataka | Third | Hypothyroidism if TSH >3 IU/L. | Not specified | Foetal outcomes among pregnant women with SCH | 5 |
| 51 | Debbarma et al72, 2023 | 772 | Hospital based | Rajasthan | Any | As per ATA 2017: Normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l).Normal free T4 (0.7 to 1.8 ng/dl) and free T3 (1.7 to 4.2 pg/ml) | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes in OH and SCH | 7 |
| 52 | Dhabhai et al7, 2023 | 2317 | Community | New Delhi | First and Second | As per National Guidelines, MoHFW, India (2014) Hypothyroidism if TSH >2.5 mIU/mL | Chemiluminescence Immunoassay | Prevalence of hypothyroidism and fetomaternal outcomes (no classification between SCH or OH) | 11 |
| 53 | Kumar et al73, 2023 | 300 | Hospital based | Punjab | Any | As per ATA 2011; The normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l).SCH if elevated TSH with normal free T3 and T4 levels; OH if elevated TSH with free T3 and T4 levels less than the normal range. | Not specified | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes (no classification between SCH or OH) | 8 |
| 54 | Palepu et al74, 2023 | 436 | Hospital based | Odisha | First and Second | As per National Guidelines, MoHFW, India (2014)Hypothyroidism if TSH >2.5 m IU/L in first trimester and >3 m IU/L in second trimester | Not specified | Prevalence of hypothyroidism | 5 |
| 55 | Vaishnav et al75, 2023 | 350 | Hospital based | Gujarat | First | As per ATA 2017;Hypothyroidism if TSH >4.0 mIU/L in first trimester; Normal range of free T3 (3.54 to 6.47 pmol/L) and T4 (11.5 to 22.7 pmol/L).SCH if elevated TSH with normal free T3, T4; OH if elevated TSH with low free T3, T4 | Chemiluminescence Immunoassay | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes in OH and SCH | 7 |
| 56 | Das et al76, 2024 | 200 | Hospital based | West Bengal | First | Normal range for TSH: first trimester (0.2–2.5 IU/L).SCH if TSH > 2.5 IU/L and serum FT4 within the normal range; OH if TSH levels more than 2.5 IU/L and low FT4 (<0.5 ng/dl) | Not specified | Prevalence of SCH and fetomaternal outcomes in SCH | 8 |
| 57 | Khawale et al77, 2024 | 350 | Hospital based | Karnataka | First and Second | As per ATA 2017, Hypothyroidism if TSH >4.0 mIU/L; SCH if TSH 2.5-10 mIU/L; OH if TSH >10 mIU/L | Not specified | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes (no classification between SCH or OH) | 7 |
| 58 | Singh et al78, 2024 | 200 | Hospital based | Rajasthan | First | As per ATA 2011; Normal range for TSH: first trimester (0.1 to 2.5 mIU/l), second (0.2 to 3.0 mIU/l), third (0.3 to 3.0 mIU/l); Normal free T4 (0.7-1.8 ng/ml)SCH if elevated TSH and normal free T4; OH if elevated TSH with less free T4 than the normal range. | Not specified | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes (no classification between SCH or OH) | 6 |
| 59 | Tejaswi et al79, 2024 | 1272 | Hospital based | Andhra Pradesh | Any | SCH if TSH between 4 and 10 mIU/L with normal T4 levels; OH if TSH >10 mIU/L or TSH >4 mIU/L with low T4 levels. | Not specified | Prevalence of hypothyroidism, OH and SCH, and fetomaternal outcomes (no classification between SCH or OH) | 2 |
| 60 | Vamja et al80, 2024 | 500 | Hospital based | Gujarat | First and Second | As per ATA 2011; Normal range for TSH (0.1-4.0 µIU/mL) and free T4 (0.7–1.7 ng/dL) OH if TSH >4.0 µIU/mL with free T4<0.7 ng/dL; SCH if TSH >4.0 µIU/mL with normal free T4. | Chemiluminescence Immunoassay | Fetomaternal outcomes among hypothyroid pregnant women (no classification between SCH or OH) | 7 |
The definitions of overall hypothyroidism (elevated TSH), subclinical hypothyroidism (elevated TSH with normal free thyroid hormone), and overt hypothyroidism (elevated TSH with low free thyroid hormone) were consistent among the selected studies; however, the reference cut-offs for TSH and free thyroid hormones (FT4 and FT3) differed across studies. Most studies used trimester-specific TSH cut-offs based on the American Thyroid Association (ATA) 2011 guidelines, while some adopted the updated ATA 2017 criteria.81,82 Fifteen of the 60 studies applied alternative thresholds, with upper limits for normal TSH varying between 4-10 mIU/L. Of the 32 studies that reported at least one maternal, foetal, or combined foeto-maternal outcome, only 10 studies explicitly described the outcome definitions used. The definitions were largely consistent and followed standard clinical definitions (e.g., IUGR was defined as birth weight less than tenth percentile for gestational age; preterm delivery as delivery before 37 completed weeks of gestation; a low Apgar score as <7 at 1 min; and preeclampsia as persistently elevated blood pressure (systolic >140 mmHg and diastolic pressure >90 mmHg on more than 2 occasions) with proteinuria after 20 weeks’ gestation ( Table).
All 60 studies were assessed for quality. The quality score ranged from 2 to 11, with a median score of 7. Among the studies, 20 studies were high quality (score ≥ 8), 34 studies were moderate quality (score 5-7), and 6 studies were low quality (score ≤ 4) ( Table).
Thyroid dysfunction in pregnant women in India
The pooled prevalence of overall hypothyroidism in pregnant women was 17% [95% (confidence interval) CI: 14%, 19%; I2 = 98.4%; N=53]. Pooled prevalence estimates of subclinical and overt hypothyroidism were 15% (95% CI: 12%, 18%, I2 = 99.2%; N=47) and 3% (95% CI:3%, 4%, I2 = 97.9%; N=42), respectively ( Fig. 2- 4).



Maternal hypothyroidism and pregnancy complications
16 studies (n=1250) documented maternal adverse outcomes in pregnant women having subclinical hypothyroidism, with a pooled prevalence of 9% (95% CI: 6%, 11%; I2=87.3%). The most frequently reported complications were preeclampsia (n=13), abruptio placentae (n=10), postpartum haemorrhage (n=8), abortion (n=8), preterm labour (n=4), pregnancy-induced hypertension (n=4), oligohydramnios (n=4), premature rupture of membranes (n=2), and placenta previa (n=1). The pooled prevalence for specific complications was 22% for pregnancy-induced hypertension (95% CI: 12%, 35%), 14% for preeclampsia (95% CI: 9%, 19%), 12% for preterm labour (95% CI: 6%, 21%), and 7% for abortion (95% CI: 1%, 17%). Other outcomes included 8% for oligohydramnios (95% CI: 4%, 11%), 4% for abruptio placentae (95% CI: 2%, 7%), 5% for premature rupture of membranes (95% CI: 4%, 8%), and 4% for placenta previa (95% CI: 2%, 8%) (Supplementary Fig. 1 and Supplementary Table II).
Twelve studies reported maternal adverse outcomes in pregnant women (n=240) with overt hypothyroidism. The pooled prevalence of adverse maternal outcomes was 12% (95% CI: 10%, 15%; I2=10.4%). The most commonly reported complications were preeclampsia (n=10), abruptio placentae (n=7), postpartum haemorrhage (n=5), and abortion (n=6). Additionally, single studies reported pregnancy-induced hypertension, preterm labour, intrauterine death, and premature rupture of membranes. The pooled prevalence for specific complications was 20% for pregnancy-induced hypertension (95% CI: 8%, 36%), 18% for preeclampsia (95% CI: 13%, 24%), 15% for abortion (95% CI: 4%, 29%), 14% for premature rupture of membranes (95% CI: 6%, 27%), and 14% for preterm labour (95% CI: 3%, 30%). Other outcomes included 10% for abruptio placentae (95% CI: 5%, 16%), and 7% for postpartum haemorrhage (95% CI: 3%, 14%) (Supplementary Fig. 2 and Supplementary Table III).
Maternal hypothyroidism and adverse birth outcomes
Sixteen studies (n=1240) reported adverse foetal outcomes in women having subclinical hypothyroidism. The overall pooled prevalence of foeto-maternal outcomes was 11% (95% CI: 9%, 14%; I2 = 87.2%). The most frequently reported complications were IUGR (n=13), low birth weight (n=12), preterm birth (n=10), NICU admission (n=6), intra-uterine death (n=6), foetal distress (n=3), stillbirth (n=4), congenital anomaly (n=2), intra-uterine death and stillbirth (n=1), low APGAR score (n=2), sepsis (n=1). The pooled prevalence for specific complications was 18% for preterm birth (95% CI: 11%, 25%), 17% for low birth weight (95% CI: 10%, 25%), 13% for foetal distress (95% CI: 4%, 26%), 11% for IUGR (95% CI: 6%, 17%), 11% for low APGAR score (95% CI: 6%, 16%), 9% for NICU admission (95% CI: 3%, 17%), and 7% for intra-uterine death (95% CI: 2%, 14%). Other outcomes included 13% prevalence of sepsis (95% CI: 5%, 30%), 4% for intra-uterine death and stillbirth (95% CI: 2%, 8%), 2% for stillbirth (95% CI: 0%, 4%), and 1% for congenital anomaly (95% CI: 0%, 2%) (Supplementary Fig. 3 and Supplementary Table II).
Eleven studies reported adverse foetal outcomes in women with overt hypothyroidism during pregnancy (n=243). The overall pooled prevalence of adverse foetal outcomes was 14% (95% CI: 11%, 17%; I2 = 26.6%). The most frequently reported complications were IUGR (n=9), low birth weight (n=9), preterm birth (n=7), NICU admission (n=4), intra-uterine death (n=3), and stillbirth (n=4). Additionally, single studies reported congenital anomaly and low APGAR score, respectively. The pooled prevalence for specific complications was 22% for low birth weight (95% CI: 13%, 31%), 16% for preterm birth (95% CI: 9%, 24%), 16% for intrauterine death (95% CI: 7%, 27%), 14% for IUGR (95% CI: 9%, 20%), 10% for NICU admission (95% CI: 3%, 19%), and 6% for stillbirth (95% CI: 1%, 13%) (Supplementary Fig. 4 and Supplementary Table III).
Meta regression analysis
A random-effects meta-regression including various study-level covariates such as definition used for hypothyroidism, trimester of assessment, laboratory method, study design, region, and year of publication explained 23.5% of the between-study variability (Wald χ2 (6) = 20.42, P< 0.001). Study design, study setting, and year of publication were significantly associated with prevalence. Variables, including definitions, trimester, and laboratory method, were not statistically significant predictors. Despite adjustment for these factors, residual heterogeneity remained extremely high (I2=97.7%), suggesting that much of the variability likely to arise from unmeasured or unreported study characteristics (Supplementary Fig. 5).
Sensitivity analysis was performed by removing lower-quality studies. The estimated pooled prevalence was 17% (95% CI: 14%, 19%; I2 = 98.1%; N=49) after omitting studies with a quality score less than six on JBI criteria for all study designs (Supplementary Fig. 6).
Leave-one-out analysis was performed to assess the influence of the single study on the pooled estimate. The exclusion of individual studies did not lead to meaningful changes in effect sizes, which consistently ranged around 16 to 17% with a very narrow 95% confidence interval ranging between 14% and 19% (Supplementary Fig. 7).
Publication bias
Asymmetry was visible upon visual inspection of the funnel plot, indicating that the pooled estimate of hypothyroidism prevalence may have been skewed by publications (Supplementary Fig. 8A and 8B). Trim-and-fill analysis also indicated publication bias. Both Egger’s (P=0.51) and Begg’s (P=0.53) tests showed no statistically significant evidence of bias.
Discussion
The present systematic review and meta-analysis, synthesising data from 60 studies across India, reveals a high prevalence of hypothyroidism among pregnant women, with pooled estimates of 17% for overall hypothyroidism, 15% for subclinical, and 3% for overt. These estimates are considerably higher than those reported in the previous meta-analysis by Yadav et al6, which found the prevalence of hypothyroidism to be around 11.1% (9.5% subclinical, 2.7% overt) in Indian pregnant women based on studies published up to 2019.6 In Yadav et al6 review, 26 of the studies contributing to prevalence estimates did not exclude women with a prior diagnosis of hypothyroidism, whereas the present review excluded such studies, thereby restricting the estimates to cases identified during pregnancy. This methodological difference may have influenced the observed prevalence, distinguishing it from earlier reviews that incorporated both previously diagnosed and newly detected cases.
In the Horn of Africa, the prevalence was 10% (95% CI: 4%, 16%) based on data from 2000 to 2023.1 Among pregnant Arab women, the estimated pooled prevalence of subclinical was 20% (95% CI: 14%, 28%), overt was 3% (95% CI: 1%, 8%), and unspecified hypothyroidism was 27% (95% CI: 10%, 45%).2 In the Middle East, pooled prevalence among adults was 7.2% (overt) and 8.3% (subclinical) between 2000 and 2021.3 A meta-analysis in European adults, based on studies between 1975 to 2012, had reported a lower prevalence of 3.1% (95% CI: 3.0%, 3.1%).4 Hypothyroidism prevalence is consistently higher in women than in men across all settings, with rising trends observed globally over time.1-3,6
As shown in our study, previous studies have also confirmed the association between hypothyroidism and adverse outcomes.5,8,83 A systematic review showed that compared with euthyroid pregnant women, those with Subclinical hypothyroidism had significantly higher risks of pregnancy loss, placental abruption, premature rupture of membranes, and neonatal death.5 The North Denmark Region Pregnancy Cohort (2011−2015), which included 14,744 singleton pregnancies, reported significantly higher frequencies of spontaneous abortion and preterm birth among those with TSH >10 mIU/L.8
Several questions regarding the care of pregnant women with thyroid disorders remain unanswered in the Indian context. The debate over universal screening continues, with most of the guidelines recommending screening of high-risk pregnant women. India currently lacks trimester-specific, population-based TSH reference ranges, with most studies using ATA guidelines and applying variable cut-offs.81,82,84 This inconsistency complicates diagnosis and prevalence estimates.
This review has a few limitations. Most included studies were hospital-based, which limits generalisability to the wider population. Variability in TSH thresholds, laboratory method used for assessment, study settings, trimester, and population across studies may have introduced heterogeneity.85 In addition, the lack of uniform reporting of key sociodemographic characteristics at the study level restricted our ability to further explore potential sources of heterogeneity through subgroup analyses. Although publication bias could not be confirmed statistically, it cannot be entirely ruled out. This review provides a comprehensive synthesis of the prevalence of hypothyroidism among pregnant women and associated adverse outcomes in the Indian context. It covers both subclinical and overt hypothyroidism, presents detailed outcome breakdowns, and includes subgroup and sensitivity analyses to support its robustness.
The rising burden and adverse consequences of hypothyroidism in pregnancy demand urgent attention. Uniform, evidence-based screening and management practices must be implemented at all levels of care. There is a pressing need for India-specific diagnostic cut-offs and large-scale prospective studies to inform treatment thresholds and long-term outcomes. Additionally, a comprehensive care package needs to be developed and evaluated that not only addresses TSH levels but also coexisting co-morbidities linked to hypothyroidism. Only through a multifaceted, context-specific strategy can we ensure optimal maternal and foetal health outcomes in hypothyroid pregnancies.
Author contributions
TL, SM: Conceptualised the study; SM, VK, MZ: Literature search, study selection, data extraction, and data curation; SM, MZ: Formal analysis and prepared the visualisations; SM, VK, MZ, TL, RM: Manuscript writing; TL, RM, BK: Supervised the overall work. All authors have read and approved the final printed version of the manuscript.
Financial support and sponsorship
None.
Conflicts of Interest
None.
Use of Artificial Intelligence (AI)-Assisted Technology for manuscript preparation
The authors confirm that there was no use of AI-assisted technology for assisting in the writing of the manuscript and no images were manipulated using AI.
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