| CTRI Number |
CTRI/2025/03/083593 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two regimen, Sliding scale and Buffered insulin in pregnant women with diabetes receiving a corticosteroid for fetal lung maturity |
|
Scientific Title of Study
|
Effect
of Sliding Scale regimen versus Buffered Insulin on the
glycemic control in diabetic women receiving antenatal corticosteroids for fetal lung maturity a randomized controlled trial |
| 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 Madhavi Dobariya |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
Obstetrics and Gynaecology office 2nd floor, WCH building, Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER), Gorimedu, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9664928132 |
| Fax |
|
| Email |
madhavidobariya5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Vishalakshi |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
Obstetrics and Gynaecology office 2nd floor, WCH building, Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER), Gorimedu, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9600203086 |
| Fax |
|
| Email |
akshivishal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Dobariya |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
Obstetrics and Gynaecology office 2nd floor, WCH building, Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER), Gorimedu, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9664928132 |
| Fax |
|
| Email |
madhavidobariya5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education & Research, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, India 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education & Research, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, India 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Madhavi Dobariya |
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) |
Antenatal ward(301 ward), Labor ward, ICU and HDU, Department of Obstetrics and gynecology, Women and Child Hospital building, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Gorimedu, Dhanvantari Nagar, Puducherry, India, 605006
Pondicherry
PONDICHERRY |
9664928132
madhavidobariya5@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Interventional studies, JIPMER, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O240||Pre-existing type 1 diabetes mellitus, in pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O241||Pre-existing type 2 diabetes mellitus, in pregnancy, childbirth and the puerperium, (3) ICD-10 Condition: O243||Unspecified pre-existing diabetesmellitus in pregnancy, childbirth and the puerperium, (4) ICD-10 Condition: O244||Gestational diabetes mellitus, (5) ICD-10 Condition: O248||Other pre-existing diabetes mellitus in pregnancy, childbirth, and the puerperium, (6) ICD-10 Condition: O249||Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buffered insulin regimen given in antenatal diabetic women with deranged blood sugar profile due to corticosteroids given for fetal lung maturity |
Between 24-36 weeks steroid will be given for fetal lung maturity in diabetic antenatal females. Every 4 hourly sugar charting will be done for 72 hours, based on sugar value buffered insulin will be given. |
| Intervention |
Sliding scale insulin regimen given in antenatal diabetic women with deranged blood sugar profile due to corticosteroids given for fetal lung maturity |
Between 24-36 weeks steroid will be given for fetal lung maturity in diabetic antenatal females. Every 4 hourly sugar charting will be done for 72 hours, based on sugar value sliding scale insulin will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Age more than 18 years
All diabetic women between 26-34 weeks of gestation developing hyperglycemia when receiving corticosteroids for fetal lung maturity |
|
| ExclusionCriteria |
| Details |
Women already on corticosteroids for other medical disorders in pregnancy
Women on beta mimetic drugs
Active labour
Diabetic ketoacidosis
Infection like pyelonephritis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the proportion of women with poor glycemic control with 4 point blood sugar profile for 72 hours between sliding scale regimen versus buffered insulin in diabetic women receiving antenatal corticosteroids for fetal lung maturity |
From 72 hours after 1st dose of steroid administration every 4 hourly blood glucose level will be measured and assess glycemic control in both groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hypoglycemia episodes
Incidence of ketoacidosis |
From 72 hours after 1st dose of steroid administration this outcome will be assessed |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
10/04/2025 |
| 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 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 study will be done in the Department of Obstetrics and Gynecology JIPMER Pondicherry from women admitted to the labor wards, antenatal wards, ICU and HDU. Women will be enrolled in the study if they fulfill the inclusion and exclusion criteria. All diabetic antenatal women beyond 26 weeks of gestation receiving corticosteroids for fetal lung maturity will be included in the study. This will include women with known preexisting T2DM, Diabetes in Pregnancy (DIP) or GDM treated with diet alone (GDM-diet) or diet and insulin therapy (GDM-insulin). GDM and DIP were defined by the revised International Association of Diabetes in Pregnancy Study Groups (IADPSG) diagnostic criteria. Written informed consent will be taken from all participants enrolled in the study in both English and local language known to the study subjects on admission to the labor room or the antenatal ward. Detailed history will be obtained from all participants and entered in the proforma. Randomization will be done in 1:1 ratio into two groups using the computerized random number generator. They will be randomly allocated to 2 groups - Group A and Group B. An independent person will be allocating the sequence. Both drugs will be coded and packed before recruitment and kept in the labor room. Allocation will be concealed using sequentially numbered opaque sealed envelopes (SNOSE) containing the drug codes. Each woman will be administered the drug in the envelope assigned corresponding to her allocation code. Participants in group A will receive the sliding scale insulin regimen and participants in Group B will receive buffered dextrose insulin regimen for the management of hyperglycemia developing after steroid administration. Both the group we will continue whatever they are receiving for sugar control-oral hypoglycemics/insulin. All participants will undergo capillary blood glucose monitoring every 4 hours and the insulin dose will be adjusted as per the regimen they are allotted to. Urine ketones will be tested if the blood glucose levels exceeds 200 mg/ dl. Participants having ketonuria will be managed as per the diabetic ketoacidosis protocol followed routinely in the department. Similarly hypoglycemic episode will be managed as per the department protocol. All the maternal baseline characteristics, blood sugar values will be noted along with episodes of hypoglycemia or ketoacidosis if any. Following 48 hours patients will be restarted on the previous treatment for diabetes mellitus and blood sugars will be monitored according to standard departmental protocol and all the blood glucose values will be noted and entered in the proforma. Poor glycemic control will be fasting >95 mg/dl, 1 hour postprandial >140 mg/dl, 2 hour postprandial >120 mg/dl Any adverse maternal events during the study will be reported to the DSMB (Data and Safety Monitoring Board) for their review, and the report will be submitted to the institute ethics committee. All the study participants will be kept under close observation in the hospital until discharge.
|