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
|
|
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
|
|
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. |