FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/104572 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness Of Enhanced Trimester Specific Thyroid Screening Compared With Standard Testing For Detecting Hypothyroidism During Pregnancy In Telangana 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr CHILUMULA MONICA 
Designation  Scientist C (Medical) 
Affiliation  ICMR-NIN 
Address  Room no.11, Maternal and Child Health and Nutrition Division Beside Tarnaka Metro Station Hyderabad Telangana

Hyderabad
TELANGANA
500007
India 
Phone  04027197308  
Fax    
Email  monica.chilumula102@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr CHILUMULA MONICA 
Designation  Scientist C (Medical) 
Affiliation  ICMR-NIN 
Address  Room no.11, Maternal and Child Health and Nutrition Division Beside Tarnaka Metro Station Hyderabad Telangana

Hyderabad
TELANGANA
500007
India 
Phone  04027197308  
Fax    
Email  monica.chilumula102@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr CHILUMULA MONICA 
Designation  Scientist C (Medical) 
Affiliation  ICMR-NIN 
Address  Room no.11, Maternal and Child Health and Nutrition Division Beside Tarnaka Metro Station Hyderabad Telangana

Hyderabad
TELANGANA
500007
India 
Phone  04027197308  
Fax    
Email  monica.chilumula102@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  ICMR 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India Phone: 91-11-26588895 / 91-11-26588980 Fax: 91-11-26588662 Email: icmrhqds@sansad.nic.in  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr CHILUMULA MONICA  ICMR-National Institute of Nutrition  Room No. 11,Maternal and Child Health and Nutrition Division, Beside Tarnaka Metro Station, Hyderabad, Telangana 500007, India. Hyderabad, TELANGANA
Hyderabad
TELANGANA 		 9493208407

monica.chilumula102@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Nutrition(ICMR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Enhanced Thyroid Screening During Pregnancy  Pregnant women will undergo enhanced thyroid screening with serum Thyroid Stimulating Hormone and Free Thyroxine testing in each trimester. Anti Thyroid Peroxidase Antibody testing will be performed in the first trimester. Maternal micronutrient status including iodine, iron, selenium, zinc and vitamin D will also be assessed at baseline to evaluate their association with thyroid dysfunction during pregnancy. 
Comparator Agent  Standard of care Antenatal Thyroid Screening  Pregnant women will undergo routine thyroid screening as per standard antenatal care. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of pregnant women identified with hypothyroidism including overt and subclinical hypothyroidism through enhanced thyroid screening compared with standard Thyroid Stimulating Hormone only screening  Baseline,18-22 weeks,28-32 weeks of gestation. 
 
Secondary Outcome  
Outcome  TimePoints 
Prevalence of iodine, iron, selenium, zinc and vitamin D deficiencies in early pregnancy and their association with thyroid dysfunction  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 dysfunction  Assessed at delivery and immediate postpartum period 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/11/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Thyroid dysfunction during pregnancy is a common and under detected condition in India and is associated with adverse maternal and neonatal outcomes. Early identification of overt and subclinical hypothyroidism is important because timely clinical management may reduce pregnancy related complications. Current antenatal practice often relies on Thyroid Stimulating Hormone only testing, which may miss cases of autoimmune thyroid dysfunction or abnormalities in Free Thyroxine levels. In addition, micronutrient deficiencies such as iodine, iron, selenium, zinc and vitamin D may influence thyroid function during pregnancy but are not routinely assessed in antenatal care settings.

This study is a randomized screening strategy  trial conducted among pregnant women attending antenatal clinics in Telangana. The primary objective is to compare the effectiveness of enhanced trimester specific thyroid screening with standard Thyroid Stimulating Hormone only screening for detecting hypothyroidism during pregnancy. Eligible pregnant women enrolled in the first trimester will be randomly assigned to either routine screening with Thyroid Stimulating Hormone testing or enhanced screening with Thyroid Stimulating Hormone and Free Thyroxine testing in each trimester along with Anti Thyroid Peroxidase Antibody testing in the first trimester.

The study also aims to assess maternal micronutrient status including iodine, iron, selenium, zinc and vitamin D in early pregnancy and examine its association with thyroid dysfunction. An additional exploratory objective is to derive trimester specific reference intervals for Thyroid Stimulating Hormone and Free Thyroxine levels in this population. Findings from this study will provide evidence to inform improved antenatal thyroid screening strategies and maternal health care practices in India.

 
Close