| CTRI Number |
CTRI/2024/06/069079 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect on blood glucose level in pregnant women after receiving antenatal corticosteroid therapy given for fetal lung maturity in diabetic versus non-diabetic pregnant women |
|
Scientific Title of Study
|
Comparison of effect of antenatal corticosteroid therapy (ACST)on glycemic status of diabetic versus non-diabetic 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 |
Surbhi Kumari |
| Designation |
Junior resident |
| Affiliation |
Pt.B.D Sharma pgims rohtak haryana |
| Address |
Pgims rohtak haryana
Department of obstetrics and gynaecology unit -4 MCH-1
Rohtak
HARYANA
124001
India |
| Phone |
7250795916 |
| Fax |
|
| Email |
surbhikri72095@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surbhi Kumari |
| Designation |
Junior resident |
| Affiliation |
Pt.B.D Sharma pgims rohtak haryana |
| Address |
Pgims rohtak haryana
Department of obstetrics and gynaecology unit -4 MCH-1
Rohtak
HARYANA
124001
India |
| Phone |
7250795916 |
| Fax |
|
| Email |
surbhikri72095@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surbhi Kumari |
| Designation |
Junior resident |
| Affiliation |
Pt.B.D Sharma pgims rohtak haryana |
| Address |
Pgims rohtak haryana
Department of obstetrics and gynaecology unit -4 MCH-1
Rohtak
HARYANA
124001
India |
| Phone |
7250795916 |
| Fax |
|
| Email |
surbhikri72095@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt B.D Sharma post graduate institute of medical sciences pgims rohtak haryana 124001 India |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma pgims rohtak haryana |
| Address |
Pt.B.D Sharma pgims rohtak haryana 124001 |
| Type of Sponsor |
Government 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 Reetu Hooda |
Pt B.D shama pgims rohtak haryana |
Department of obstetrics and gynaecology ward2
Rohtak
HARYANA |
7988474535
drreetumore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antenatal corticosteroid therapy will be given for fetal lung maturity and will assess the changes in blood glucose level |
After ACST ,the changes in glycemic status of diabetic versus non-diabetic pregnant women from day1 to Day5 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women receiveing ACST |
|
| ExclusionCriteria |
| Details |
Diabetic ketoacidosis
Patient taking drugs which causes hyperglycemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood sugar levels after ACST administration |
Base line,DAY 1,DAY2,DAY3,DAY4,DAY5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in management for control of blood glucose levels |
Day1 to Day5 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
26/06/2024 |
| 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="0"
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
|
Comparison of effect of antenatal corticosteroid therapy (ACST)on glycemic status of diabetic versus non-diabetic pregnant women given for fetal lung maturity and the changes in blood glucose level will be seen and managed further which will be better for maternal and neonatal outcomes. |