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CTRI Number  CTRI/2020/07/026623 [Registered on: 16/07/2020] Trial Registered Prospectively
Last Modified On: 15/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Hematological Indices in Pre-eclampsia 
Scientific Title of Study   Study of Hematological Indices as predictors of Pre-eclampsia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kodumuri Loukya 
Designation  MD Student 
Affiliation  AIIMS RAIPUR 
Address  Department of Obstetrics and Gynaecology All India Institute of Medical Sciences, Raipur.
Department of Obstetrics and Gynaecology All India Institute of Medical Sciences, Raipur.
Raipur
CHHATTISGARH
492099
India 
Phone  9963018886  
Fax    
Email  kodumuriloukya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandrashekhar Shrivastava 
Designation  Associate Professor 
Affiliation  AIIMS RAIPUR 
Address  Department of Obstetrics and Gynaecology All India Institute of Medical Sciences, Raipur.
Department of Obstetrics and Gynaecology All India Institute of Medical Sciences, Raipur.
Raipur
CHHATTISGARH
492099
India 
Phone  7000599101  
Fax    
Email  chandan_1708@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Chandrashekhar Shrivastava 
Designation  Associate Professor 
Affiliation  AIIMS RAIPUR 
Address  Department of Obstetrics and Gynaecology All India Institute of Medical Sciences, Raipur.
Department of Obstetrics and Gynaecology All India Institute of Medical Sciences, Raipur.
Raipur
CHHATTISGARH
492099
India 
Phone  7000599101  
Fax    
Email  chandan_1708@yahoo.co.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences. 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences Raipur 
Address  Department of Obstetrics and Gynaecology All India Institute of Medical Sciences, Raipur. 
Type of Sponsor  Research institution and hospital 
 
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 Kodumuri Loukya  AIIMS RAIPUR  Department of Obstetrics and Gynaecology All India Institute of Medical Sciences, Raipur.
Raipur
CHHATTISGARH 
9963018886

kodumuriloukya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee,AIIMS RAIPUR.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant women of age 18-40years, with singleton pregnancy and 13-20 weeks gestational age, attending antenatal care: Outpatient department (OPD) and/or Inpatient department (IPD) in department of Obstetrics and Gynecology at All India Institute of Medical Sciences, Raipur and giving fully valid consent to participate in the study. 
 
ExclusionCriteria 
Details  ● Age < 18 years and > 40 years
● Multi fetal pregnancy
● Women who have co existing medical illness
o Chronic Hypertension
o Diabetes mellitus
o Chronic liver disease
o Chronic Kidney disease
o Established Cardiovascular disease
o Collagen vascular disease
o Hematological disease
o Ongoing infection or systemic inflammatory conditions
o Autoimmune disease
● History of Smoking, alcoholism and drug abuse
● Pregnancy complications like membrane rupture or intrauterine fetal death
● History of fever, HELLP.
● Patient refusal to participate in study

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the role of the Hematological indices such as Neutrophil to Lymphocyte ratio, Platelet to lymphocyte ratio, Mean Platelet Volume, Platelet distribution width, Red cell Distribution Width and Delta Neutrophil Index as predictors of pre-eclampsia.  from the time of recruitment till 6 weeks postpartum  
 
Secondary Outcome  
Outcome  TimePoints 
a) To study the role of Hematological indices such as Neutrophil to Lymphocyte ratio, Platelet to lymphocyte ratio, Mean Platelet Volume, Platelet distribution width, Red cell Distribution Width and Delta Neutrophil Index as markers of severity in women with pre-eclampsia.
b) To determine the diagnostic accuracy of Neutrophil to Lymphocyte ratio, Platelet to lymphocyte ratio for the diagnosis of severe and non-severe pre-eclampsia.
 
from the time of recruitment till 6 weeks postpartum  
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
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)   20/07/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Preeclampsia is associated with increased maternal and fetal morbidity. Activation of inflammatory responses leads to widespread endothelial dysfunction and resultant manifestations of multi organ dysfunction in Preeclampsia. Early recognition of Preeclampsia and its severity will help in guiding optimal obstetric management in pregnant women. Hematological indices such as Neutrophil to Lymphocyte ratio, Platelet to lymphocyte ratio, Mean Platelet volume, Platelet distribution width, Plateletcrit, Red cell Distribution Width and Delta Neutrophil Index, gives an insight to the underlying inflammation in Preeclampsia.

 These indices can be used as an emerging tool in prediction of pre-eclampsia as well as a marker is estimating the severity of pre-eclampsia. Its predictive value could be used for early diagnosis, timely referral and intervention to avoid life-threatening complication of pre-eclampsia.  

Moreover, these indices are easy, inexpensive to measure, reproducible and can be used as a marker of underlying inflammation in preeclampsia.

There has been small number of researches on the use of these indices to predict pre-eclampsia as well as severity of pre-eclampsia. Therefore, the present study aims to study the role of  hematological indices such as Neutrophil to Lymphocyte ratio, Platelet to lymphocyte ratio, Mean Platelet volume, Platelet distribution width, Plateletcrit, Red cell Distribution Width and Delta Neutrophil Index,  as predictors of pre-eclampsia.

 
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