| CTRI Number |
CTRI/2024/06/069376 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Effect of drug for fetal lung maturation during pregnancy on mothers blood glucose levels and fetal well being |
|
Scientific Title of Study
|
Effect of antenatal Dexamethasone therapy on maternal blood glucose levels and fetal well being |
| 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 ADITI |
| Designation |
junior resident |
| Affiliation |
government medical college sector 32 chandigarh |
| Address |
Department of Obstetrics and Gynaecology ,level 4,D block Government Medical College and Hospital ,sec 32 B Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8968176619 |
| Fax |
|
| Email |
aditirock31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navneet Takkar |
| Designation |
Professor |
| Affiliation |
Government medical college and hospital ,sector 32 chandigarh |
| Address |
Government medical college and hospital, obstetrics and gynecology department Level 4, D block, sector 32 B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121582 |
| Fax |
|
| Email |
navneettakkar2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navneet Takkar |
| Designation |
Professor |
| Affiliation |
Government medical college and hospital ,sector 32 chandigarh |
| Address |
Government medical college and hospital, obstetrics and gynecology department Level 4, D block, sector 32 B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121582 |
| Fax |
|
| Email |
navneettakkar2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynecology , level 4 D block ,Government Medical College and Hospital, Sector 32 B Chandigarh, INDIA ,PINCODE 160030 |
|
|
Primary Sponsor
|
| Name |
Government medical college and hospital |
| Address |
Department of Obstetrics and Gynecology, block D, level 4 , Government medical college and hospital sector-32 B, Chandigarh, India PIN code: 160030 |
| 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 Aditi |
Government Medical College and Hospital, sector 32B chandigarh |
Department of Obstetrics and gynecology , Level 4 , D block Government medical college and hospital, sector 32 B , Chandigarh ,PIN code: 160030, India
Chandigarh
CHANDIGARH |
8968176619
aditirock31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government medical college ,Gmch 32 Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O429||Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone therapy |
Dexamethasone therapy given as 6 mg 4 doses intramuscularly 12 hours apart for fetal lung maturation. Total duration of Dexamethasone therapy is 48 hours. There is no comparator agent in this trial. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Pregnant women between 26-34 weeks of gestation with threatened preterm labor pains and premature rupture of membranes
2 Antenatal women between 34-39 weeks planned for lower segment cesarean section (LSCS)
|
|
| ExclusionCriteria |
| Details |
1) Pregnant women with pre-existing diabetes and gestational diabetes mellitus.
2) Pregnant women with fetal growth restriction.
3) Patients who require immediate termination of pregnancy or are in established preterm labor.
4) Pregnant women with evidence of infection, where corticosteroid therapy may lead to flare-up of infection.
5) Patients with chronic kidney disease, and pre-existing adrenal and pancreatic dysfunction.
6) Pregnant women who have received tocolysis with beta-mimetic agents.
7) Multifetal gestation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To study the effect of Dexamethasone therapy on maternal blood glucose levels
in pregnant women without diabetes mellitus
2) To study the fetal effects of antenatal Dexamethasone therapy including fetal movements, Biophysical profile, and Umbilical artery Doppler
3)To assess the neonatal outcome of antenatal dexamethasone therapy
 
|
1) blood glucose level in antenatal women will be determined at baseline followed by 3 days of premeal and post meal blood sugar levels.
2) fetal movements, biophysical profile, and umbilical artery Doppler will be done at baseline followed by 3 days of monitoring to study the effect of dexamethasone therapy on fetal well being. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/07/2024 |
| 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="6"
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
|
This study will be conducted in the Department of Obstetrics and Gynecology at Government Medical College and Hospital Chandigarh, focusing on pregnant women between 26-34 weeks of gestation with pre-term labor pains, premature rupture of membranes, and those who need cesarean section. Antenatal women will be recruited after informed consent and ethical clearance from the Institutional Ethics Committee. The study is a prospective observational study, with a sample size calculated based on 95% nondiabetic on glucocorticosteroids showing an increase in blood glucose levels above 140 mg/dl.
The study includes pregnant women without diabetes and those planned for lower segment cesarean section (LSCS). Exclusion criteria include pregnant women with pre-existing diabetes and gestational diabetes mellitus, fetal growth restriction, patients requiring immediate termination of pregnancy or in established preterm labor, pregnant women with evidence of infection, chronic kidney disease, pre-existing adrenal and pancreatic dysfunction, tocolysis with beta-mimetic agents, and multifetal gestation.
All patients visiting gynecological OPD and admitted to the labor room with the inclusion criteria will be enrolled after informed consent. Detailed demographic details, antenatal previous obstetrics, and medical history will be taken. A baseline general examination and obstetrical examination will be done before recruitment into the study. Routine blood samples will be taken, including complete blood count, renal function test, liver function test, c-reactive protein, and a vaginal swab for culture sensitivity if indicated.
To exclude diabetes, random blood sugar will be tested in all recruited patients before starting Dexamethasone injection. Patients with a normal 75 gm glucose tolerance test (GTT) done between 24-28 weeks of gestation are included in the study. Dexamethasone dosage administration will be in the form of four doses of 6 mg separated by 12 hours intramuscularly. Baseline fetal movement count, nonstress test, biophysical profile, and umbilical artery Doppler flow will be studied before the administration of corticosteroid therapy. |