| CTRI Number |
CTRI/2024/06/069042 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the efficacy of Fasting Blood glucose versus IADPSG Criteria in diagnosis of Gestational Diabetes Mellitus. |
|
Scientific Title of Study
|
Comparing the efficacy of First Trimester Fasting Blood Glucose versus IADPSG Criteria at 24 to 28 weeks in Diagnosis of Gestational Diabetes Mellitus- A One year Prospective Observational study at KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi. |
| 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 Chilukuri Anila Reddy |
| Designation |
PG Resident, |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Obstetrics and Gynecology, 1st Floor, Jawaharlal Nehru medical College, KLE University, Belagavi, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
8688547563 |
| Fax |
|
| Email |
dr.anila3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Patil |
| Designation |
Professor, Obstetrics and Gynecology |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Obstetrics and Gynecology, First floor, Jawaharlal Nehru Medical College, KLE University, Belagavi, Karnataka, India.
Belgaum
KARNATAKA
590010
India |
| Phone |
9845565454 |
| Fax |
|
| Email |
kamalpatil1967@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chilukuri Anila Reddy |
| Designation |
PG Resident |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Obstetrics and Gynecology, First Floor, Jawaharlal Nehru Medical College, KLE University, Belagavi, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
8688547563 |
| Fax |
|
| Email |
dr.anila3@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, Karnataka, India. Pincode- 590010 |
|
|
Primary Sponsor
|
| Name |
Chilukuri Anila Reddy |
| Address |
Room Number- 605, New PG Ladies Hostel, JNMC Campus, Nehru Nagar, KLE University, Belagavi,
Pincode - 590010
Karnataka
India |
| 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 Chilukuri Anila Reddy |
Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi. |
G+0 Floor, OPD Number 10, Department of Obstetrics and Gynecology, Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi, Karnataka.
Belgaum
KARNATAKA |
8688547563
dr.anila3@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: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fasting blood glucose versus IADPSG criteria |
This particular study is being done in the same patient but different weeks of gestation of pregnancy. Details are in the same patient - fasting blood glucose in first trimester and based on the result , they are followed up for 24 to 28 weeks period of gestation to repeat IADPSG criteria. Everything clearly mentioned methodology. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women above 18 years of age
2. Pregnant women till their 28 weeks period of Gestation |
|
| ExclusionCriteria |
| Details |
1. Pregnant women diagnosed with Pre Gestational Diabetes
2. Pregnant women on Corticosteroids. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the efficacy of Fasting blood glucose in First trimester and IADPSG Criteria in 24 to 28 weeks in diagnosis of Gestational Diabetes mellitus. |
till 28 weeks period of Gestation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feto Maternal Outcomes in Gestational Diabetes Mellitus |
40 weeks |
|
|
Target Sample Size
|
Total Sample Size="175"
Sample Size from India="175"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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)
|
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
|
NEED FOR THE STUDY : | International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria that is most widely used for diagnosing GDM recommends that GDM can be diagnosed in 24 to 28 weeks period of gestation if any of the values of fasting plasma glucose(FPG), 1-hour and 2-hour Plasma Glucose is equal to or above 92 mg/dl, 180 mg/dl or 153 mg/dl respectively. Fasting blood sugar measurement at the time of first booking will be useful to screen for previously undiagnosed pre-existing diabetes and also help to predict the development of Gestational diabetes mellitus earlier. The main need for study is to compare the first trimester Fasting blood glucose against IADPSG criteria in 24 to 28 weeks period of gestation for diagnosis of GDM and to determine the diagnostic accuracy of these methods.
STUDY PROTOCOL : Subjects will be recruited according to the inclusion and exclusion criteria. A detailed history with physical examination will be taken. Participants in the study visiting antenatal OPD in their first trimester will be tested for Fasting blood glucose with overnight fast of atleast 8 hours. If the Fasting blood glucose is < 92 mg/dl then they will be diagnosed as Non GDM. If the Fasting blood glucose value is in between 92 to 125 mg/dl then they will be diagnosed as GDM. If the Fasting Blood glucose value is >/= 126 mg/dl then they will be diagnosed with Overt Diabetes. Participants who were diagnosed as Non GDM through the fasting blood glucose value < 92mg/dl during their first visit will be advised to follow up during 24 to 28 weeks period of gestation and will be repeated with 75g Oral glucose tolerance test( OGTT) according to IADPSG criteria after an overnight fast of atleast 8 hours. Venous blood sample was drawn at fasting, 1 hour and 2 hours after load with 75g of glucose. According to IADPSG criteria GDM can be diagnosed if any one of the values of Fasting plasma glucose, 1- hour and 2- hour plasma glucose is equal to or above 92 mg/dl, 180 mg/dl and 153 mg/dl respectively. | |