| CTRI Number |
CTRI/2019/06/019541 [Registered on: 06/06/2019] Trial Registered Prospectively |
| Last Modified On: |
09/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on disorders related to thyroid gland ,its associated risk factors and birth outcome among pregnant women attending the Urban health centre in Delhi. |
|
Scientific Title of Study
|
Study on prevalence of thyroid disorders,its associated risk factors and birth outcome among pregnant women attending the Urban health centre in Delhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NAVYA G |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF COMMUNITY MEDICINE, 3RD FLOOR, PATHOLOGY BLOCK,MAULANA AZAD MEDICAL COLLEGE ,NEW DELHI-110002
Central
DELHI
110002
India |
| Phone |
8860559143 |
| Fax |
|
| Email |
navya92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PANNA LAL |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF COMMUNITY MEDICINE
3RD FLOOR, PATHOLOGY BLOCK,MAULANA AZAD MEDICAL COLLEGE ,NEW DELHI-110002
Central
DELHI
110002
India |
| Phone |
9968604247 |
| Fax |
|
| Email |
dr.plal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PANNA LAL |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF COMMUNITY MEDICINE
3RD FLOOR, PATHOLOGY BLOCK,MAULANA AZAD MEDICAL COLLEGE ,NEW DELHI-110002
North West
DELHI
110002
India |
| Phone |
9968604247 |
| Fax |
|
| Email |
dr.plal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MAULANA AZAD MEDICAL COLLEG,NEW DELHI 110002 |
|
|
Primary Sponsor
|
| Name |
NAVYA G |
| Address |
DEPARTMENT OF COMMUNITY MEDICINE,MAULANA AZAD MEDICAL COLLEGE ,NEW DELHI |
| Type of Sponsor |
Other [MAULANA AZAD MEDICAL COLLEGE ] |
|
|
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 |
| NAVYA G |
Urban Health Centre |
Urban Health Centre ,Gokalpuri,
New Delhi-110094
Central
DELHI |
8860559143
navya92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,MAULANA AZAD MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
THE STUDY SUBJECTS ARE TESTED FOR THYROID DISORDERS DURING PREGNANCY |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ALL PREGNANT WOMEN WHO ATTEND ANTENATAL CLINIC OF URBAN HEALTH CENTRE GOKALPURI IRRESPECTIVE OF PERIOD OF GESTATION.
PREGNANT WOMEN WHOSE EXPECTED DATE OF DELIVERY IS WITHIN THE STUDY PERIOD |
|
| ExclusionCriteria |
| Details |
WOMEN WHO ARE TAKING DRUGS SUCH AS AMIODARONE,LITHIUM,IODINE FOR THEIR ILLNESS OR WHO HAVE UNDERGONE RADIO IODINE UPTAKE STUDY IN PAST. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PREVALENCE OF THYROID DISORDERS AMONG THE PREGNANT WOMEN ATTENDING UHC,GOKALPURI |
ONE YEAR OF STUDY PERIOD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COMPARISON OF BIRTH OUTCOMES OF THOSE PREGNANT WOMEN WITH THYROID DISORDERS AND THOSE WITHOUT THYROID DISORDERS |
AFTER DELIVERY |
|
|
Target Sample Size
|
Total Sample Size="217"
Sample Size from India="217"
Final Enrollment numbers achieved (Total)= "217"
Final Enrollment numbers achieved (India)="217" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2019 |
| Date of Study Completion (India) |
31/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THE STUDY IS AN OBSERVATIONAL FOLLOW UP STUDY WHICH AIMS TO ESTIMATE THE PREVALENCE OF THYROID DISORDERS AMONG PREGNANT WOMEN AND FOLLOW THEM UP TO ASSESS THE BIRTH OUTCOME AMONG THOSE WITH THYROID DISORDER AND THOSE WITHOUT THYROID DISORDER.THE STUDY SUBJECTS WILL BE SELECTED BY SYSTEMATIC RANDOM SAMPLING METHOD.EVERY 3RD REGISTERED PREGNANT WOMEN WILL BE ENROLLED IN THE STUDY . AFTER OBTAINING THE INFORMED WRITTEN CONSENT 4 ML VENOUS BLOOD WILL BE WITHDRAWN AFTER FOLLOWING ASEPTIC PRECAUTIONS AND A SEMI-STRUCTURED INTERVIEW SCHEDULE WILL BE FILLED BY THE INVESTIGATOR.THYROID FUNCTION TEST WILL BE DONE FROM THE ENDOCRINE LABORATORY OF DEPARTMENT OF BIOCHEMISTRY ,MAULANA AZAD MEDICAL COLLEGE.THE THE SUBJECT WILL BE GIVEN A UNIQUE IDENTIFICATION NUMBER AND WILL BE CALLED FOR FOLLOWUP ON NEXT DAY TO PROVIDE THE RESULT.THOSE WITH THYROID DYSFUNCTION WILL BE REFERRED TO PHYSICIAN FOR EXPERT MANAGEMENT TO LOK- NAYAK HOSPITAL.THEY WILL BE FOLLOWED UP FOR NEXT ANC VISIT AND AT DELIVERY TO ASSESS THE BIRTH OUTCOME. |