| CTRI Number |
CTRI/2024/04/065416 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
PREDICTION OF GESTATIONAL DIABETES MELLITUS BY MEASURING BODY FAT IN FIRST TRIMESTER CLINICALLY AND ULTRASONOGRAPHICALLY |
|
Scientific Title of Study
|
BODY FAT MEASUREMENT IN FIRST TRIMESTER BY CLINICAL AND ULTRASONOGRAPHIC PARAMETERS AS PREDICTOR 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)
|
| Name |
ARCHANA |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
Department of Obstetrics and gynaecology
Dr RML HOSPITAL
Baba kharak singh road
Type 3 President estate
New Delhi 110001
Central
DELHI
110001
India |
| Phone |
8287569014 |
| Fax |
|
| Email |
meenaarchana097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Head of the Department and Professor |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
Department of obstetrics and gynaecology
Dr RML HOSPITAL
Baba kharak singh road
Type 3 President estate
New Delhi 110001
Central
DELHI
110001
India |
| Phone |
9968604346 |
| Fax |
|
| Email |
ash64kr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Head of the Department and Professor |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
Department of obstetrics and gynaecology
Dr RML HOSPITAL
Baba kharak singh road
Type 3 President estate
New Delhi 110001
DELHI
110001
India |
| Phone |
9968604346 |
| Fax |
|
| Email |
ash64kr@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS AND DR RML HOSPITAL
Baba kharak singh road
Type 3 President estate
New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
DR ARCHANA |
| Address |
Department of obstetrics and gynaecology
Gynae office
maternity nursing home
Dr RML HOSPITAL
Baba kharak singh road
Type 3 President estate
New Delhi 110001 |
| 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 ARCHANA |
RML HOSPITAL |
Department of obstetrics and gynaecology
ABVIMS
Baba kharak singh road
Type 3 President estate
New Delhi 110001
Central
DELHI |
8287569014
meenaarchana097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee ABVIMS and DR RML HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with singleton live pregnancy with normal oral glucose tolerance test coming in first trimester. |
|
| ExclusionCriteria |
| Details |
1 Pre-pregnancy diabetes
2 Miscarriage in the current pregnancy
3 Multiple pregnancies
4 Patient unable to undergo follow-up like psychiatric patients etc
5 Women with uncontrolled hypothyroidism, chronic diseases, autoimmune disorders, taking medications known to affect metabolism such as steroids, metformin, etc
6 Abdominal scar
7 Palpable Abdominal mass |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between clinical and ultrasonographic parameters of body fat in pregnant females with gestational diabetes mellitus |
First visit in first trimester to development of gestational diabetes mellitus (32weeks ) |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
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)
|
15/04/2024 |
| 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="4"
Days="27" |
|
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
|
This research will start from first trimester to development of gestational diabetes mellitus. In this study initially we will undergo a thorough history taking and clinical assessment to reach a diagnosis. An ultrasound will be performed for obtaining body fat index. Patient will be followed from first antenatal care to development of gestational diabetes mellitus (32weeks) |