| CTRI Number |
CTRI/2024/06/069153 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Concentration of a blood marker called Serum Ferritin in early Pregnancy and risk of subsequent development of Diabetes in Second Trimester of pregnancy |
|
Scientific Title of Study
|
Serum Ferritin Concentration in early Pregnancy and risk of
subsequent development of Gestational Diabetes Mellitus |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Aditi Bharuka |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9831875730 |
| Fax |
|
| Email |
bharukaaditi82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986143120 |
| Fax |
|
| Email |
Rekha.upadhya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Bharuka |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9831875730 |
| Fax |
|
| Email |
bharukaaditi82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal
Hebri Road, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Private 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 Aditi Bharuka |
Kasturba Hospital, Manipal |
Department of Obstetrics and Gynaecology , First Floor, Labor Theatre, Kasturba Hospital,Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
09831875730
bharukaaditi82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
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 |
Singleton Pregnancy
First Trimester Pregnant Women |
|
| ExclusionCriteria |
| Details |
Multiple Pregnancies
Overt Diabetics
Iron Deficiency on treatment
Presence of any Hemoglobinopathies
Acute/Chronic Inflammatory Conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| If a strong association is proven between Serum Ferritin Assay in first trimester and risk of development of Gestational Diabetes Mellitus , then it can be used as a predictive marker for GDM |
24weeks of Gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
29/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/06/2024 |
| 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 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
|
The study will be conducted in KH, Manipal. Ethical clearance will be obtained from IEC.
Eligible Pregnant women between 11-14weeks of gestation are recruited for OBG OPD during their routine antenatal check up or during their patient stay.
RBS> 200mg/dl or HbA1c > 6.5% was described as overt diabetic and patients with Pre-existing Type 1 or Type 2 and patients with increased Pre-conceptional BMI>26 are not eligible for the study.
Detailed description of the study procedure will be explained to them and the willing and eligible participants will be recruited after informed written consent.
In all pregnant women participating in the study the following will be done- A) Thorough History Taking B) BMI Calculation C) Gestational Age determined on the last menstrual period confirmed by an early First Trimester Ultrasound Scan Special Investigations- A) First Trimester Ferritin Assay between 12-16weeks B) Oral Glucose Tolerance Test between 24-28weeks of gestation after an overnight fast of greater than 8hours
All these patients will be followed up during second trimester and will undergo 75g OGTT between 24-28weeks of period of gestation. The test will be done following an overnight fast of greater than 8hours with sampling at 1hour and 2hour post load.
Diagnostic criteria of GDM (IADPSG): Fasting glucose > 92mg/dl Post prandial 1hr > 180mg/dl
Post prandial 2 hr> 153mg/dl One or more abnormal values from the 75g OGTT are diagnosed as GDM. Positively diagnosed GDM and negatively diagnosed GDM patient will be differentiated. After the investigations we will determine the correlation between Serum Ferritin and Glucose Tolerance Test. According to the test, the pregnant women will lie in two different categories- 1. Normal Glucose Tolerance 2. Gestational Diabetes Mellitus
|