| CTRI Number |
CTRI/2024/10/075356 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Association of S.ferritin in development of gestational Diabetes mellitus |
|
Scientific Title of Study
|
Association of serum ferritin level in early second trimester of pregnancy with development of gestational diabetes mellitus: A Prospective Observational 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 Hemaxi Kantilal Kukarvadiya |
| Designation |
1st year Resident doctor in obgy department |
| Affiliation |
Sir T Hospital, Bhavnagar |
| Address |
Gopnath maternity home Obstetrics and gynaecology department, Sir T Hospital Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7574084449 |
| Fax |
|
| Email |
kukarvadiyahemaxi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajni Parikh |
| Designation |
Associate Professor |
| Affiliation |
Sir T Hospital , Bhavnagar |
| Address |
Department obstetrics and gynaecology department
Sir T hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9408967969 |
| Fax |
|
| Email |
rajnimaulik@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemaxi Kantilal Kukarvadiya |
| Designation |
1st year Resident doctor in obgy department |
| Affiliation |
Sir T Hospital, Bhavnagar |
| Address |
Gopnath maternity home, obstetrics and gynaecology department, Sir T Hospital Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7574084449 |
| Fax |
|
| Email |
kukarvadiyahemaxi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and Sir T. hospital, Bhavnagar- 364001, Bhavnagar, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Dr Hemaxi Kantilal Kukarvadiya |
| Address |
Obstetrics and Gynaecology department
Sir T hospital, Bhavnagar
|
| Type of Sponsor |
Other [Self] |
|
|
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 Hemaxi Kantilal Kukarvadiya |
Sir T. hospital, Bhavnagar |
Gopnath maternity home, obstetrics and gynaecology department, Sir T Hosoital, Bhavnagar
Bhavnagar
GUJARAT |
7574084449
kukarvadiyahemaxi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Goverment Medical College , Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Screening of GDM by S. Ferritin |
only one time screening of GDM by S. Ferritin at 14-20 weeks of gestation. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
14-28 weeks of gestation age |
|
| ExclusionCriteria |
| Details |
Women who diagnose GDM Before 20 weeks of Pregnancy
Type 1 and Type 2 Diabetes
Hematological disorder ( Hemoglobinopathy, sickle cell anemia,Thalassemia)
Seizure Disorders
Acute and Chronic inflammatory or infective Disease
Acute or Chronic liver Disease
Patient on corticosteroids therapy.
Medical disorders complicating pregnancy :
Hypertension
Thyroid disorders
Cardiac disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association S.Ferritin in Development of GDM |
first at 14-20 weeks
then at 24-28 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gestational Diabetes mellitus associated with High S. Ferritin |
24-28 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/10/2024 |
| 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="3"
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
|
o All
enrolled women will be subjected to detailed history, examination and routine
ANC investigations including blood sugar
o Serum
ferritin between 14 -20 weeks will be measured by ARCHITECT ferritin assay
o then
they will be devided in 2
groups
1.S.ferritin ≥60 (ng/ml)
2.S.ferritin <60 (ng/ml) —All
enrolled pregnant women will be followed and subjected to blood glucose test by
OGTT (Oral
Glucose Tolerance Test)
method between 24 and 28 weeks of gestation
—Enrolled
pregnant women with blood glucose level FBS ≥92mg/dl, 1 hour blood glucose
level ≥180mg/dl, 2 hour blood glucose level ≥153 mg/dl out of this if 2
parameters are high that is labled as GDM |