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CTRI Number  CTRI/2020/09/027531 [Registered on: 01/09/2020] Trial Registered Prospectively
Last Modified On: 31/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Effect of various parameters of complete blood count in patients with preeclampsia 
Scientific Title of Study   Evaluation of Leucocyte and Platelet indices in Preeclampsia compared to normotensive Asian Indian pregnant women 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidushi Kulshrestha 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room No 3082-A, Dept. of Obstetrics and Gynecology, Teaching Block, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9891910880  
Fax    
Email  drvidushi.kul@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vidushi Kulshrestha 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room No 3082-A, Dept. of Obstetrics and Gynecology, Teaching Block, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9891910880  
Fax    
Email  drvidushi.kul@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jitendra Adhikari 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Room No 3082-A, Dept. of Obstetrics and Gynecology, Teaching Block, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  7619563254  
Fax    
Email  jitendraadhikari454@gmail.com  
 
Source of Monetary or Material Support  
Department of Hematology, AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  AIIMS, Ansari Nagar East, New Delhi  
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 Vidushi Kulshrestha  All india Institute of Medical Sciences, New Delhi  3082-A, Department of Obstetrics and Gynecology, AIIMS, Ansari Nagar East
New Delhi
DELHI 
9891910880

drvidushi.kul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post-Graduation Research AIIMS New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O149||Unspecified 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  Patients of preeclampsia meeting following criteria
Systolic blood pressure>140 and/or DBP>90 mm of Hg on two occasions at least 4 hours apart; and proteinuria of >1+ on dipstick or 300 mg/day, after 20 week of gestation
 
 
ExclusionCriteria 
Details  Chronic hypertension
Overt diabetes/GDM type A2
Renal Disease
Fever within previous 1 week of diagnosis
Collagen vascular disorder
Rheumatoid arthritis
Known autoimmune disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
- Values of NLR,MLR,PLR,MPV,PDW in patient of preeclampsia
- Correlation of these markers with severity of preeclampsia

NLR: Neutrophil to lymphocyte ratio
MLR: Monocyte to lymphocyte ratio
PLR: Platelet to lymphocyte ratio
MPV: Mean platelet volume
PDW: Platelet distribution width 
At recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery 
 
Secondary Outcome  
Outcome  TimePoints 
1.Maternal outcome: Eclampsia, HELLP syndrome, Mode of delivery
2.Fetal outcome: fetal growth restriction,intrauterine fetal death,prematurity and low birth weight
3.Levels of other haematological markers such as RDW, Plateletcrit, absolute values of platelet count in preeclampsia

 
- Haematological markers at recruitment and at 28, 32 and 36 weeks (as applicable according to the gestational age at recruitment) and at delivery
- Maternal and fetal outcomes at delivery
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   03/09/2020 
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="6"
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)?  

Response - NO
Brief Summary  

Hyperactivation of inflammatory and immunologic responses in pre-eclampsia causes a marked increase in neutrophil count and modulation of neutrophil function toward greater production of superoxide compared with nitric oxide, which results in endothelial damage and dysfunction. Pre-eclampsia is also known to cause platelet activation, manifesting as low platelet count and high mean platelet volume (MPV).

Systemic immune inflammation indices derived from peripheral blood cells have recently attracted much attention because they are easily measurable and available. Abnormal changes in white blood cells counts have been observed in Preeclampsia, although the role of these systemic inflammatory indicators in clinical assessment, differential diagnosis and prognosis evaluation of PE remains unclear. 

Hence this prospective comparative observational studyis being planned to assess the level of leucocyte and platelet indices in preeclampsia in Asian Indian women and comparison with normotensive pregnant women and to study the correlation of these indices with severity of preeclampsia as well as correlation  among various parameters as none of the previous prospective study has evaluated correlation between these indices.

The study group will comprise of 40 pregnant women aged 18–40 years who are diagnosed with pre-eclampsia (blood pressure elevation ≥140/90 mm Hg on two occasions 4 hours apart with proteinuria or any of the severe features of pre-eclampsia: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, cerebral or visual disturbances). 80 gestational age-matched, healthy pregnant women will be enrolled into the control group. In this study,  ratio of cases : controls will be maintained as 1:2; so as to get adequate representation among the controls and also to compensate for controls who will be likely to develop preeclampsia in the late stage of pregnancy, as such cases will be excluded from analysis. So sample size for cases and control will be 40 and 80 respectively.

Primary objectives of this study will be to assess the level of leucocyte and platelet indices (NLR, MLR, PLR, PDW, MPV) in preeclampsia in Asian Indian women and comparison with normotensive pregnant women and to correlate these indices with severity of preeclampsia

Secondary objectives will be to find the correlation among NLR, MLR, PLR, PDW, MPV; to correlate these markers with adverse feto-maternal and neonatal outcome; to evaluate other haematological markers such as RDW, Plateletcrit, absolute values of platelet count in preeclampsia.

 
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