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CTRI Number  CTRI/2026/01/100279 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 03/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational 
Study Design  Other 
Public Title of Study   To determine of increased levels of Placental growth factor in mother during 1st trimester can predict development of gestational Diabetes mellitus later in pregnancy 
Scientific Title of Study   Elevated Placental Growth Factor at 11 to 13 weeks 6 days period of gestation as a predictor of 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  Gauri Mann 
Designation  Junior Resident  
Affiliation  Kasturba Hospital , Manipal 
Address  Department of Obstetrics and Gynecology Kasturba Hospital Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9910220881  
Fax    
Email  manngauri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayaraman Nambiar 
Designation  Professor 
Affiliation  Kasturba Hospital, Manipal 
Address  Department of Obstetrics and Gynecology Kasturba Hospital Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845082923  
Fax    
Email  drram.nambiar@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Jayaraman Nambiar 
Designation  Professor 
Affiliation  Kasturba Hospital, Manipal 
Address  Department of Obstetrics and Gynecology Kasturba Hospital Madhav Nagar, Eshwar Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845082923  
Fax    
Email  drram.nambiar@manipal.edu  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Gauri Mann 
Address  Department of Obstetrics and Gynecology Kasturba Hospital , Manipal Madhav nagar Karnataka - 576104 
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 Gauri Mann  Kasturba hospital   Department of OBG, Udupi-Hebri road, Madhav Nagar, Manipal, Karnataka - 576104
Udupi
KARNATAKA 		 9910220881

manngauri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O244||Gestational diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  48.00 Year(s)
Gender  Female 
Details  Singleton pregnancies at 11-13 weeks 6 days of gestation at the
time of combined screening by USG and biochemistry markers
in the maternal serum and who continue antenatal check ups in
our hospital.
2. Willing to participated in the study and give informed consent. 
 
ExclusionCriteria 
Details  1. Multiple pregnancies
2. Pregnancies with pre-existing hypertensive disorders or Pre-
existing Diabetes Mellitus ( type 1 and 2 ), previous pregnancies
with GDM
3. Pregnancies with known chromosomal abnormalities and/or
structural defects
4. Pregnancies that resulted in IUD or abortions
5. Pregnancies with early onset FGR.
6. Patient not willing to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine if elevated PlGF can predict GDM later on in pregnancy  At the end of pregnancy 
 
Secondary Outcome  
Outcome  TimePoints 
nil   
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
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)   14/01/2026 
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 , titles “Elevated placental growth factor at 11-13 weeks
6 days period of gestation as a predictor of gestational diabetes
mellitus,” is a prospective observational cohort study conducted at a
tertiary care hospital, utilizing data collected over the Antenatal
period , starting from time of NT Scan till termination of pregnancy ,
of patients that fulfil the inclusion criteria . Data collected over the
antenatal period will include PlGF levels at the time of NT Scan and
aneuplaoidy screening ( part of regular ANC , done after 11
completed weeks but before 14 completed weeks , that is by 13
weeks 6 days of gestation) , OGTT/GCT levels ( part of ANC , done
between 24-28 weeks in regular clinical practice) , maternal details
such as GPLA score, anthropometric measurements ( 1 st trimester
BMI, height) collected in 1 st trimester at the time of NT scan /
Aneuploidy screening . Patients will be followed up after NT
scan/aneuploidy screening during regular ANC visits . OGTT values (
done as part of regular ANC visit between the POG 24-28 weeks) will
be recorded in a proforma and patient will be classified as GDM
(gestational diabetes mellitus) and non GDM based on the same
according to standard cut-offs used in regular practice. Subsequent
FBS/PPBS values ( part of routine ANC tests for GDM patients) will
be recorded in the same proforma. Data will be entered in machine
learning tool (Random forest ) to help in formulation of a model that
will help predict GDM development . Ethical approval will be
obtained , with all data anonymized to maintain confidentiality. The
study’s findings can help in providing a valuable early predictor of
GDM in pregnancy that could potentially decrease both maternal and
fetal morbidity and mortality risks.
 
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