| CTRI Number |
CTRI/2025/07/091163 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
looking into the prevalence and complications of Subclinical Hypothyroidism in Pregnancy |
|
Scientific Title of Study
|
Prevalance and complications of subclinical hypothyroidism in pregnancy in tertiary care center- A cross sectional study |
| 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 Manas Vikash |
| Designation |
Tutor |
| Affiliation |
KAHER, Belagavi |
| Address |
Jawaharlal Nehru Medical College Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09572240750 |
| Fax |
|
| Email |
dr.manasvikas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANAS VIKASH |
| Designation |
Tutor |
| Affiliation |
KAHER, Belagavi |
| Address |
Jawaharlal Nehru Medical College Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09572240750 |
| Fax |
|
| Email |
dr.manasvikas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANAS VIKASH |
| Designation |
Tutor |
| Affiliation |
KAHER, Belagavi |
| Address |
Jawaharlal Nehru Medical College Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09572240750 |
| Fax |
|
| Email |
dr.manasvikas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Prabhakore Hospital and Medical research centre Nehru nagar Belagavi India 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Prabhakar Kore Hospital |
| Address |
Nehru nagar Belagavi India 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MANAS VIKASH |
Dr Prabhakar Kore hospital Belagavi Karnataka |
Department of obstetrics and gynaecology first floor Nehru nagar Belagavi 590010
Belgaum
KARNATAKA |
09572240750
dr.manasvikas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women attending Department of Obstetrics and Gynecology OPD of KLES Dr. Prabhakar Kore hospital from 2024 to 2025 |
|
| ExclusionCriteria |
| Details |
History of miscarriage or stillbirth
Underlying medical diseases
Pre-gestational diabetes
Chronic hypertension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To prevent the critical complications during pregnancy and at the time of delivery |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
05/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Hypothyroidism is defined as a decrease production of thyroid hormone that may be due to primary damage on the thyroid gland or secondary as a result of hypothalamic or pituitary disease. There are two types of hypothyroidism: frank hypothyroidism with a deficiency of thyroxin(T4) and the presence of symptoms, subclinical with normal T4 values and high thyroid stimulating hormone(TSH) and usually without symptoms. Subclinical hypothyroidism has been defined as a state of and abnormally high TSH level with a normal free thyroxin level without any clinical symptoms of hypothyroidism. |