| CTRI Number |
CTRI/2025/09/094131 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
IMPACT OF ANTENATAL STEROID INJECTIONS FOR BABYS LUNG MATURITY ON BLOOD SUGAR LEVELS IN PREGNANT WOMEN |
|
Scientific Title of Study
|
EFFECT OF ANTENATAL CORTICOSTEROIDS FOR FETAL LUNG MATURITY ON GLYCEMIC STATUS IN PREGNANT WOMEN- AN OBSERVATIONAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UMAPRIYA C |
| Designation |
PG STUDENT |
| Affiliation |
MGMCRI |
| Address |
DEPARTMENT OF OBGY
ROOMNO. 317
DIVISION - E3
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PILLAYARKUPPAM
PONDICHERRY
607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894510796 |
| Fax |
|
| Email |
cumapriya66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PALLAVEE P |
| Designation |
PROFESSOR |
| Affiliation |
MGMCRI |
| Address |
DEPARTMENT OF OBGY
DIVISION- E3
ROOM NO.317
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PILLAYARKUPPAM
PONDICHERRY
607402
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9489693270 |
| Fax |
|
| Email |
drppallavee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
UMAPRIYA C |
| Designation |
PG STUDENT |
| Affiliation |
MGMCRI |
| Address |
DEPARTMENT OF OBGY
ROOM NO-317
DIVISION- E3
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PILLAYARKUPPAM
PONDICHERRY
607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894510796 |
| Fax |
|
| Email |
cumapriya66@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHATMA GANDHI MEDICAL COLLEGE AND RESARCH INSTITUTE
PUDUCHERRY
INDIA
607402 |
|
|
Primary Sponsor
|
| Name |
NIL SPONSOR |
| Address |
Nil |
| Type of Sponsor |
Private 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 |
| UMAPRIYA C |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
MGMCRI
DEPARTMENT OF OBGY
ROOM NO.317
DIVISION- E3
SBV Campus
Pillayarkuppam
Pondicherry
Pondicherry
PONDICHERRY |
9894510796
cumapriya66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Age 18-45 yrs.
2 Gestational age between 28 – 36 weeks.
3 Planned for administration of antenatal corticosteroids.
4 Willing to undergo Glycemic monitoring and provide informed consent
|
|
| ExclusionCriteria |
| Details |
1 Diabetic ketoacidosis
2 Women for whom the prescribed course of corticosteroid cannot be completed ( eg active labour).
3 Suspected chorioamnionitis .
4 Chronic steroid therapy or conditions requiring long-term steroid use.
5 Severe maternal comorbidities (e.g., renal or hepatic dysfunction
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Change in maternal glycemic levels after ACS
2 Duration and persistence of hyperglycemia
3 Comparison between diabetic and non diabetic women
|
BASELINE
DAY 1
DAY 3
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Proportion of diabetic AND non diabetic women requiring insulin or OHA post ACS
2 Risk factors associated with persistent or severe hyperglycemia
|
BASELINE
DAY 1
DAY 3 |
|
|
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)
|
09/10/2025 |
| 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="2"
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
|
In my study i will be including antenatal mothers including both Gestational diabetic and Non diabetic and are receiving corticosteroids indicated for development of fetal lung maturity and will monitor their CBG values at regular intervals to evaluate the impact of steroids in maternal glycemic variations and also effectively manage the rise in blood glucose values |