| CTRI Number |
CTRI/2024/06/069020 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Thyroid function tests in women with twin pregnancy. |
|
Scientific Title of Study
|
Thyroid function tests in women with twin gestation in first half of pregnancy |
| 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 Aleena S Aboobacker |
| Designation |
Junior Resident (PG) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology ,
Maulana Azad medical college,
New Delhi.
Central
DELHI
110002
India |
| Phone |
9400367184 |
| Fax |
|
| Email |
aleenaaboobacker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aarti Sood Mahajan |
| Designation |
Director Professor and HOD |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology ,
Maulana Azad medical college,
New Delhi.
Central
DELHI
110002
India |
| Phone |
9968604301 |
| Fax |
|
| Email |
aartis_mahajan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aarti Sood Mahajan |
| Designation |
Director Professor and HOD |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology ,
Maulana Azad medical college,
New Delhi.
Central
DELHI
110002
India |
| Phone |
9968604301 |
| Fax |
|
| Email |
aartis_mahajan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical College |
| Address |
Bahadurshah Zafar road
New Delhi - 110002 |
| Type of Sponsor |
Government 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 |
| Dr Aleena S Aboobacker |
Maulana Azad Medical College |
Department of OBG
MAMC, New Delhi
Central
DELHI |
9400367184
aleenaaboobacker@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMC Institutional Ethics Committee Maulana azad medical college ,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Twin pregnancy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Women with live twin pregnancy
2.Women with live singleton pregnancy ,with matched period of gestation |
|
| ExclusionCriteria |
| Details |
1.Molar pregnancies
2.Pre-existing thyroid disorders
3.Women who received exogenous Human chorionic gonadotropin
4.Artificial reproductive technique or assisted pregnancies which influence thyroid hormone level |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The difference in maternal thyroid stimulating hormone level between twin pregnancy and singleton pregnancy at matched period of gestation |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.comparison of free T3 and free T4 levels in singleton and twin pregnancy
2.Correlation of TSH and hCG in singleton and twin pregnancy |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study will be conducted in the department of Physiology in association with Department of OBG MAMC New Delhi. In the study we would be investigating the maternal Thyroid hormone levels in females with Twin gestation During 1st Half of Pregnancy and compare it with the thyroid hormone levels in females with singleton gestation. |