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CTRI Number  CTRI/2024/03/064501 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To Compare the performance of fetal heart in pregnancies with and without gestational diabetes mellitus 
Scientific Title of Study   COMPARISON OF FOETAL MYOCARDIAL PERFORMANCE INDEX IN WOMEN WITH AND WITHOUT GESTATIONAL DIABETES MELLITUS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vasudha Singal 
Designation  PG Student 
Affiliation  ABVIMS and Dr RML Hospital 
Address  Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital Baba Kharak Singh Marg Near Gurudwara Bangla Sahib Connaught Place New Delhi Delhi 110001   
Department of Obstetrics and Gynaecology Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital
New Delhi
DELHI
110001
India 
Phone  8295622052  
Fax    
Email  vasudhasingal05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jaya Chawla 
Designation  Associate Professor  
Affiliation  ABVIMS and Dr RML Hospital 
Address  Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital Baba Kharak Singh Marg Near Gurudwara Bangla Sahib Connaught Place New Delhi Delhi 110001   
Room no. 507 PGIMER Administrative Building Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital
New Delhi
DELHI
110001
India 
Phone  9871115949  
Fax    
Email  jayachawla51@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Vasudha Singal  
Designation  Pg student 
Affiliation  ABVIMS and Dr RML Hospital 
Address  Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital Baba Kharak Singh Marg Near Gurudwara Bangla Sahib Connaught Place New Delhi Delhi 110001   
Department of Obstetrics and Gynaecology Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital
New Delhi
DELHI
110001
India 
Phone  8295622052  
Fax    
Email  vasudhasingal05@gmail.com  
 
Source of Monetary or Material Support  
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital Baba Kharak Singh Marg Near Gurudwara Bangla Sahib Connaught Place New Delhi Delhi 110001     
 
Primary Sponsor  
Name  Vasudha Singal  
Address  Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital Baba Kharak Singh Marg Near Gurudwara Bangla Sahib  Connaught Place New Delhi Delhi 110001    
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vasudha Singal  ABVIMS and Dr RML Hospital   Department of Obstetrics and Gynaecology Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital Baba Kharak Singh Marg Near Gurudwara Bangla Sahib  Connaught Place New DelhiDelhi 110001 
New Delhi
DELHI 		 8295622052

vasudhasingal05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committe ABVIMS Dr RML Hospital New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Women without gestational diabetes mellitus 
Patients  (1) ICD-10 Condition: O244||Gestational diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Maternal age between 18-35 years
Singleton live fetus
Between 32-36 period of gestation 
 
ExclusionCriteria 
Details  Maternal hypertensive disease
Any chronic disease
Known structural or chromosomal anomaly in the fetus.
Cardiac heart rate abnormalities
Foetal growth restriction
Tocolytic therapy
Betamethasone administration 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Myocardial performance index in gestational diabetes group and euglycemia group  At 32-36 weeks of gestation 
 
Secondary Outcome  
Outcome  TimePoints 
Neonatal hypoglycemia   During hospital stay of neonate  
5 min Apgar less than 7  At the time of birth of baby 
Cord pH less than 7.2  At the time of birth of baby 
Neonatal polycythemia   During hospital stay of neonate  
Neonatal hyperbilirubinemia   During hospital stay of neonate  
Need for neonatal resuscitation   At time of birth of baby  
NICU stay  During hospital stay of baby  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   30/03/2024 
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="4"
Days="1" 
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   The research will take place on pregnant women between 32-36 weeks of gestation.Foetal myocardial performance index shall be compared between women with and without gestational diabetes mellitus. The pregnancy will be managed as per established hospital protocols. The study will continue till the discharge of mother and baby from hospital.  
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