| CTRI Number |
CTRI/2025/01/079004 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Timing Matters: Comparing Early vs. Late Postpartum OGTT Screening in Women with Gestational Diabetes |
|
Scientific Title of Study
|
A Prospective Study to Compare Early versus Late Postpartum Oral Glucose Tolerance Test Screening in Patients with Gestational Diabetes. |
| 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 Deepali Grag |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Room N0. 710 MCH block AIIMS, New Delhi.
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi-110029.
Central
DELHI
110029
India |
| Phone |
9818706660 |
| Fax |
|
| Email |
drdeepaligarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arundhati |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Room N0. 710 MCH block AIIMS, New Delhi.
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi-110029.
Central
DELHI
110029
India |
| Phone |
9400874063 |
| Fax |
|
| Email |
aaruvijay8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Grag |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Room N0. 710 MCH block AIIMS, New Delhi.
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi-110029.
Central
DELHI
110029
India |
| Phone |
9818706660 |
| Fax |
|
| Email |
drdeepaligarg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Arundhathi K V, Junior Resident, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi)
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 Deepali Garg |
All India Institute of Medical Sciences, New Delhi |
Room no. 710 Mother and Child Block AIIMS, New Delhi, Sri Aurobindo Marg, Ansari Nagar East New Delhi Delhi 110029
East
DELHI |
9818706660
drdeepaligrag@ggmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of AIIMS New Delhi |
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 |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients diagnosed with GDM and who are less than 96 hours postpartum. |
|
| ExclusionCriteria |
| Details |
Pre-existing diabetes/ Overt diabetes.
Patients not willing for participation.
Not able to take three meals.
Patient on corticosteroids, antidepressants, diuretics, beta blockers.
Patients with history of gastric bypass surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sensitivity, specificity, Positive predictive value (PPV), Negative predictive value (NPV) of early post-partum OGTT for impaired glucose tolerance and diabetes mellitus.
|
At 12 week post partum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compliance for post partum follow-up
|
Follow up rate at 6 to 12 week postpartum to repeat GTT (glucose tolerance test) |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
01/02/2025 |
| 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
|
An oral glucose tolerance test (OGTT) during the delivery hospitalization may be of use in certain circumstances in which postpartum follow-up is challenging and resources could be focused on women with an abnormal screening immediately after the delivery. Insulin resistance has been shown to improve shortly after delivery, as evidenced by the decreased insulin dose requirements in women with diabetes treated with insulin. Additionally, metabolic mediators involved in the development of GDM have been shown to decline to nonpregnant levels hours after delivery. It is reasonable to investigate whether GTT can be done after the first 48 hours (2 days) while the patient is still hospitalized. |