|
In order to understand hypothyroidism during pregnancy among Indian women, the Indian Council of Medical Research (ICMR) has invited Expression of Interests (EoIs) from researchers and institutions to contribute data from ongoing or completed pregnancy cohort studies or randomized controlled trials (RCTs).
Submission timeline is December 1, 2025.
The objective is to generate high-quality evidence to provide deeper insights into hypothyroidism during pregnancy, based on current reference ranges for thyroid function.
Primary objectives of the EoI is to estimate the prevalence of hypothyroidism (overt and subclinical) among pregnant women across diverse Indian populations using current trimester-specific reference ranges, to identify risk factors associated with hypothyroidism in pregnancy, to assess the associations between subclinical hypothyroidism (SCH) and adverse pregnancy and foetal outcomes (e.g., preeclampsia, gestational hypertension, gestational diabetes, stillbirth, low birth weight, preterm birth etc.).
This would also develop normative reference values for thyroid function parameters in Indian pregnant women.
Hypothyroidism is among the most common endocrine disorders affecting women of reproductive age with pregnancy increasing vulnerability due to increased thyroid hormone and iodine demands. The burden of maternal hypothyroidism is notably high in India. Untreated or inadequately managed hypothyroidism in pregnancy can have far-reaching consequence including miscarriage, preeclampsia and placental complications in the mother as well as preterm birth, low birth weight and impaired neurodevelopment in the child.
Emerging evidence suggests that hypothyroidism in pregnancy is shaped not only by iodine deficiency but by a confluence of nutritional (iron, selenium), environmental (endocrine disrupting chemicals), metabolic (obesity) and autoimmune factors. These interrelated influences underscore the need for a more comprehensive understanding of risk pathways and outcomes in Indian women.
Eligibility for data contribution and to be considered for pooled analysis, contributing datasets must meet the following criteria with reference to Study Design: Prospective pregnancy cohort, cross sectional, case-control or randomized controlled trial (RCT), Study Period: Data collected after Year 2000, Sample Size: At least 300 pregnant women or evidence of an appropriate power calculation for smaller studies.
The eligibility criteria also include availability of biochemical data on thyroid function and/or availability of corresponding bio-samples, availability of relevant clinical outcome data (e.g., maternal or neonatal health indicators) and a data dictionary must be provided.
Mandatory data elements include Thyroid parameters: TSH (and where available, FT4), measured during pregnancy (preferably in all three trimesters), cut-offs used for defining thyroid status, gestational age at sample collection (preferably by ultrasound or early LMP confirmation), and maternal characteristics: Age, parity, BMI/weight, haemoglobin, iodine status (if available).
Pregnancy outcomes include Maternal: preeclampsia, gestational hypertension, gestational diabetes, anaemia, miscarriage etc.
Neonatal: gestational age at delivery, birth weight, spontaneous abortions, miscarriages, stillbirth, congenital anomalies, early neonatal death etc. and study population information: Geographic region, rural/urban setting and recruitment criteria.
Contributors will provide de-identified datasets under a formal Data Use Agreement (DUA) between ICMR and the contributing institution. Contributors will retain full ownership of their original data. Institutional Ethics Committee (IEC) approval for secondary use of data must be confirmed or obtained as per the contributor’s institutional policy.
This is a non-funding, scientific collaboration. Contributors will receive co-authorship in all publications arising from this work, following ICMJE authorship criteria. Acknowledgement in all ICMR policy briefs, technical reports and guidelines emerging from the findings.
|