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CTRI Number  CTRI/2021/05/033724 [Registered on: 21/05/2021] Trial Registered Prospectively
Last Modified On: 10/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective 
Study Design  Other 
Public Title of Study   Placental growth factor and haeme indices to predict gestational diabetes mellitus 
Scientific Title of Study   Role of Maternal serum placental growth factor and hematological parameters at 11–14 weeks of gestation to predict gestational diabetes mellitus: A Prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mounika koduri 
Designation  JUNIOR RESIDENT 1ST YEAR 
Affiliation  KASTURBA MEDICAL COLLEGE MANIPAL 
Address  OBGYN DEPARTMENT KMC MANIPAL
OBGYN DEPARTMENT KMC MANIPAL
Udupi
KARNATAKA
576104
India 
Phone  7087806268  
Fax    
Email  mounikakoduri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR B S SUJATHA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  KASTURBA MEDICAL COLLEGE MANIPAL 
Address  OBGYN DEPARTMENT KMC MANIPAL
OBGYN DEPARTMENT KMC MANIPAL
Udupi
KARNATAKA
576104
India 
Phone  8660778169  
Fax    
Email  bssujata@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mounika koduri 
Designation  JUNIOR RESIDENT 1st YEAR 
Affiliation  KASTURBA MEDICAL COLLEGE MANIPAL 
Address  OBGYN DEPARTMENT KMC MANIPAL
OBGYN DEPARTMENT KMC MANIPAL
Udupi
KARNATAKA
576104
India 
Phone  7087806268  
Fax    
Email  mounikakoduri@gmail.com  
 
Source of Monetary or Material Support  
KASTURBA HOSPITAL , MANIPAL 
 
Primary Sponsor  
Name  Dr Mounika Koduri 
Address  JUNIOR RESIDENT 1ST YEAR OBGYN DEPARTMENT KMC MANIPAL , UDUPI , KARNATAKA - 576104 
Type of Sponsor  Private 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 
MOUNIKA KODURI  KMC MANIPAL  OBGYN DEPARTMENT
Udupi
KARNATAKA 		 7087806268

mounikakoduri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , KMC MANIPAL  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 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Inclusion Criteria: Singleton pregnancies at 11-14 weeks of gestation, at the time of combined
screening for aneuploidy and preeclampsia by ultrasound scan and maternal serum
biochemistry, who come to obstetrics and gynaecology OPD of Kasturba Hospital Manipal for
regular ANC checkup. 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1)Women who have been diagnosed with hypertensive disorders in pregnancy
2)Previous pregnancy complicated with Gestational diabetes mellitus (GDM)
3)Pre-existing diabetes mellitus detected by HbA1C >6
4)Pregnancies with chromosomal abnormal fetuses or structural defects at 11-14 weeks
5)Pregnancies diagnosed with severe Early onset IUGR
6)Those who are 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 
1) Diagnosis of GDM and its correlation with PlGF and blood parameter values at 11-14 weeks
2) Correlation of Gestational age at delivery (in weeks), Birth weight of baby (in grams),
Proportion of GDM with NICU admission 24 hours, rate of Live baby at the time of discharge
to PIGF values. 		 1) Diagnosis of GDM and its correlation with PlGF and blood parameter values at 11 a 14 weeks
2) Correlation of Gestational age at delivery (in weeks), Birth weight of baby (in grams),
Proportion of GDM with NICU admission 24 hours, rate of Live baby at the time of discharge
to PIGF values. 
 
Secondary Outcome  
Outcome  TimePoints 
2) Correlation of Gestational age at delivery (in weeks), Birth weight of baby (in grams) at 36-40 weeks
Proportion of GDM with NICU admission 24 hours, rate of Live baby at the time of discharge
to PIGF values. 		 2) Correlation of Gestational age at delivery (in weeks), Birth weight of baby (in grams),at 36-40 weeks
Proportion of GDM with NICU admission 24 hours, rate of Live baby at the time of discharge
to PIGF values. 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
Final Enrollment numbers achieved (Total)= "320"
Final Enrollment numbers achieved (India)="320" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/05/2021 
Date of Study Completion (India) 01/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/11/2022 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Gestational diabetes mellitus (GDM) is one of the leading causes for maternal morbidity. It is a
major public health problem in India with a high prevalence rate of 4.6% to 14%. GDM typically
diagnosed from 24 weeks of gestation. Early diagnosis and prediction are vital, as it can improve
the antenatal care and thus prevents the adverse perinatal outcomes like macrosomia,
shoulder dystocia, stillbirths by lifestyle interventions commenced in early pregnancy (<=20
weeks). Placental growth factor (PlGF) which is a placenta-derived angiogenic protein, is
involved in the regulation of placental vascular development. Studies show that there is an
increase in placenta derived growth factor (PlGF) in Gestational diabetes mellitus (GDM) due to
a compensatory angiogenic mechanism in response to hyperglycemia induced placental
hypoxia. So, in our study we are investigating whether Placental growth factor (PlGF) value in
first trimester predicts the occurrence of Gestational diabetes mellitus (GDM). Low-grade
chronic inflammation is associated with various obstetric complications such as preterm birth,
preeclampsia, and gestational diabetes mellitus. Platelets indices such as Mean platelet volume
(MPV), plateletcrit (PCT), platelet distribution width (PDW) plays important role in blood
coagulation and inflammatory process. Also, CBC parameters such as neutrophil lymphocyte
ratio (NLR) have been studied to predict Gestational diabetes mellitus (GDM), hence we are
trying to create a prediction model for GDM using these parameters.
 
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