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
|
|
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
|
|
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 |
â— Age < 18 years and > 40 years
â— Multi fetal pregnancy
â— 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
â— History of Smoking, alcoholism and drug abuse
â— Pregnancy complications like membrane rupture or intrauterine fetal death
â— History of fever, HELLP.
â— 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. |