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Effectiveness Of Enhanced Trimester Specific Thyroid Screening Compared With Standard Testing For Detecting Hypothyroidism During Pregnancy In Telangana

Effectiveness of Enhanced Trimester-Specific Thyroid Screening versus Standard of Care for Detecting Hypothyroidism in Pregnancy: A Randomized Diagnostic Strategy Trial Nested in Pregnancy-Cohort in Telangana - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104572
Enrollment
1000
Registered
2026-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E039- Hypothyroidism, unspecified

Interventions

Intervention1: Enhanced Thyroid Screening During Pregnancy: Pregnant women will undergo enhanced thyroid screening with serum Thyroid Stimulating Hormone and Free Thyroxine testing in each trimester.

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women aged 18 to 45 years attending antenatal clinics in Telangana. Women in early pregnancy up to twelve weeks of gestation with singleton pregnancy who are willing to provide written informed consent and participate in follow up visits will be included.

Exclusion criteria

Exclusion criteria: Women with known thyroid disease currently on treatment. Women with multiple pregnancy. Women with severe chronic medical illness requiring long term medication. Women who are unable or unwilling to provide informed consent or comply with study procedures.

Design outcomes

Primary

MeasureTime frame
Proportion of pregnant women identified with hypothyroidism including overt and subclinical hypothyroidism through enhanced thyroid screening compared with standard Thyroid Stimulating Hormone only screeningTimepoint: Baseline,18-22 weeks,28-32 weeks of gestation.

Secondary

MeasureTime frame
Prevalence of iodine, iron, selenium, zinc and vitamin D deficiencies in early pregnancy and their association with thyroid dysfunctionTimepoint: At baseline assessment in the first trimester at enrolment;Incidence of adverse pregnancy outcomes including preterm birth, low birth weight, gestational diabetes mellitus and hypertensive disorders of pregnancy among women with thyroid dysfunctionTimepoint: Assessed at delivery and immediate postpartum period

Countries

India

Contacts

Public ContactDr CHILUMULA MONICA

ICMR-NIN

monica.chilumula102@gmail.com04027197308

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026