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CTRI Number  CTRI/2024/03/064784 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 28/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Role of biomarkers to predict pregnancy outcome in gestational diabetes 
Scientific Title of Study   Prediction of materno-fetal outcome in gestational diabetes mellitus using SFLT1/PLGF Ratio in third trimester.  
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 Divya Pandey 
Designation  Professor 
Affiliation  VMMC and Safdarjung hospital, Delhi 
Address  Department of Obstetrics and Gynaecology, VMMC AND SAFDARJUNG HOSPITAL, NEW DELHI

South
DELHI
110029
India 
Phone  8860198440  
Fax    
Email  dr_devya1@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Prity Yogi 
Designation  Post graduate student 
Affiliation  VMMC and Safdarjung hospital, Delhi 
Address  Department of Obstetrics and Gynaecology, VMMC AND SAFDARJUNG HOSPITAL, NEW DELHI

South
DELHI
110029
India 
Phone  919717364342  
Fax    
Email  prityyogi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prity Yogi 
Designation  Post graduate student 
Affiliation  VMMC and Safdarjung hospital, Delhi 
Address  Department of Obstetrics and Gynaecology, VMMC AND SAFDARJUNG HOSPITAL, NEW DELHI

South
DELHI
110029
India 
Phone  919717364342  
Fax    
Email  prityyogi@gmail.com  
 
Source of Monetary or Material Support  
Safdarjung Hospital Delhi 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College AND SAFDARJUNG HOSPITAL 
Address  MG Road, Delhi-110029, India 
Type of Sponsor  Government medical college 
 
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 Divya Pandey  VMMC and Safdarjung hospital, Delhi  Department of Obstetrics and Hospital, VMMC and Safdarjung hospital, Delhi-110029, India
South
DELHI 		 8860198440

dr_devya1@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, VMMC and Safdarjung Hospital, Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O992||Endocrine, nutritional and metabolic diseases 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  Antenatal women with singleton pregnancy and GDM in third trimester 
 
ExclusionCriteria 
Details  1 Pre-pregnancy diabetes (type 1 and type 2).
2 Congenital malformation in fetus.
3 Antenatal women with intra-uterine fetal death (IUFD).
4 Pre-existing medical comorbidity –chronic hypertension, Overt DM, Chronic Kidney Disease,Heart disease etc.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
SFLT 1 and PLGF ratio.

 		 Baseline

 
 
Secondary Outcome  
Outcome  TimePoints 
Materno-fetal outcome in women with gestational diabetes mellitus.
 		 Baseline 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   03/04/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   AIM: To study the predictive value of soluble fms like tyrosine kinase and placental growth factor ratio for materno-fetal outcome in women with gestational diabetes mellitus(GDM).
OBJECTIVES:
1. To determine soluble fms like tyrosine kinase1 and placental growth factor ratio and materno-fetal outcome in gestational diabetes mellitus and to assess the predictive value of soluble fms like tyrosine kinase1 and placental growth factor ratio for adverse materno-fetal outcome in gestational diabetes mellitus.
VENUE OF STUDY: The present study will be conducted in the Department of Obstetrics and Gynaecology and Department of pathology VMMC & Safdarjung Hospital, New Delhi.
STUDY DESIGN: Prospective cohort Observational Study.
DURATION OF STUDY: 18 months.
STUDY SETTING: Department of Obstetrics and Gynaecology and department of pathology VMMC & Safdarjung Hospital, New Delhi.
STUDY POPULATION: All antenatal women fulfilling the eligibility criteria during the study period.
ELIGIBILITY CRITERIA
 INCLUSION CRITERIA-
• Antenatal women with singleton pregnancy and GDM at age of ≥18 years and Period of gestation >28 weeks.
EXCLUSION CRITERIA
• Pre-pregnancy diabetes (type 1 and type 2).
• Congenital malformation in fetus.
• Antenatal women with intra-uterine fetal death (IUFD).
• Pre-existing medical comorbidity –chronic hypertension, Overt DM, Chronic Kidney Disease,Heart disease etc.
METHODOLOGY
This study titled “Prediction of materno-fetal outcome in gestational diabetes mellitus using sflt1/plgf ratio in third trimeseter.” is a prospective cohort study that will be performed with 200 participants over 18 months duration in the Department of Obstetrics and Gynaecology, VMMC and SJH, New Delhi. All antenatal women admitted for delivery will be screened for eligibility as per inclusion and exclusion criteria of the study. All eligible women will be enrolled in the study after informed consent.
Participants’ baseline characteristics, including age, gestational age, BMI, gravidity, parity, medical history, obstetrical history, and family history of diabetes will be recorded using a pre-designed proforma.
A single venous blood sample (2 mL) will be collected from each participant after enrolment for estimation of SFLT 1 and PLGF levels. Samples will be collected in a plain tube and transported to the laboratory in ice-cold condition with biohazard symbol on the transportation box. The SFLT 1 and PLGF ratio will be calculated from the obtained values. 2ml of blood collected in plain vial will be centrifuged to separate the serum sample. SFLT 1 and PLGF will be performed on COBAS e411analyser which is based on the Chemiluminescence assay.
Participants will be followed up until delivery to assess perinatal outcomes. Maternal and fetal parameters will be recorded as follows.
Maternal parameter will include the period of gestation (POG) at delivery, mode of delivery, development of any obstetrics comorbidity,maternal HDU/ICU admission and maternal moratlity.
Fetal parameters will include birth weight,Apgar score at 5 minutes,NICU admission and Neonatal mortality.
The data will be tabulated in an excel spreadsheet and statistical analysis will be done using SPSS2021 (IBM Corp.)
                                                                           OUTCOME MEASURES
1.) SFLT 1 and PLGF ratio.
2.) Materno-fetal outcome in women with gestationl diabetes mellitus.

 
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