| CTRI Number |
CTRI/2024/07/070057 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to predict gestational diabetes in Ist trimester of pregnancy. |
|
Scientific Title of Study
|
A multifactorial study of maternal physical, psychological and health parameters for early prediction of gestational diabetes mellitus in pregnant women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seveka Bali |
| Designation |
Physiotherapist |
| Affiliation |
PGIMER,Chandigarh |
| Address |
New OPD,PGIMER , sector 12, Chandigarh 160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
8722324705 |
| Fax |
|
| Email |
17seveka@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Sonia singh |
| Designation |
Assistant Professor |
| Affiliation |
Punjabi university,Patiala |
| Address |
Physiotherapy department, Punjabi University, Patiala
Patiala PUNJAB 147002 India |
| Phone |
9872637661 |
| Fax |
|
| Email |
soniaphysio239@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Seveka Bali |
| Designation |
Physiotherapist |
| Affiliation |
PGIMER,Chandigarh |
| Address |
New OPD,PGIMER , sector 12, Chandigarh 160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
8722324705 |
| Fax |
|
| Email |
17seveka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gynecology department, PGIMER,Chandigarh,India,160012 |
|
|
Primary Sponsor
|
| Name |
Seveka Bali |
| Address |
PGIMER, Sector 12,Chandigarh,India,160012 |
| 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 Seveka Bali |
Post Graduate Institute of Medical Education and Research |
Room no.2053,antenatal unit,Gynecology department, PGIMER, Chandigarh Chandigarh CHANDIGARH |
8722324705
17seveka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research,Chandigarh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant females in their first trimester are the participant of this study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Age 18 years or greater
2.Pregnant females in their Ist trimester
|
|
| ExclusionCriteria |
| Details |
Pregnant females with ectopic pregnancy, renal, hepatic, endocrinal,and metabolic disorders, on medication for diabetes and hypertension, psychiatric illness, or any neuromuscular problem will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gestational diabetes mellitus |
24-28 weeks of pregnancy |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="201" Sample Size from India="201"
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)
|
15/10/2024 |
| 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="3" 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 research proposal focuses on predicting gestational diabetes mellitus (GDM) in pregnant women by analyzing a range of physical, psychological, and health parameters. It begins by highlighting the complexities of pregnancy and the potential risks associated with GDM, including adverse outcomes for both mother and child. The proposal emphasizes the importance of early detection and intervention to mitigate these risks. The study aims to fill existing gaps in research, particularly in the Indian context, by investigating various predictors of GDM during the first trimester of pregnancy. These predictors include biomarkers, hematological markers, physical factors such as BMI and physical activity, psychological factors like perceived stress, and health parameters like blood pressure. The proposed methodology involves a prospective case-control study conducted among pregnant women attending a gynecological department. Data collection will include demographic information, anthropometric measurements, biochemical and hematological tests, physical activity assessments, and stress evaluations. Participants will be followed up until the end of pregnancy, with GDM diagnosis based on established criteria. Data analysis will involve statistical techniques such as logistic regression to identify significant predictors of GDM. The study will contribute valuable insights into the predictors of GDM during the first trimester of pregnancy, ultimately assisting healthcare professionals in implementing effective preventive measures and management strategies. |