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CTRI Number  CTRI/2025/08/093346 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A test for screening Preeclampsia early in pregnancy: A Study Across Multiple Hospitals 
Scientific Title of Study   A Prospective Multicentric Performance Evaluation study for a rapid Preeclampsia screening test 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amitabha Bandyopadhyay 
Designation  KENT Chair for entrepreneurship & innovation 
Affiliation  IIT Kanpur 
Address  Skeletal developmental lab, Lab 10 ,Department of Biological Sciences and Bioengineering, Indian Institute of Technology Kanpur

Kanpur Nagar
UTTAR PRADESH
208016
India 
Phone  915122594072  
Fax    
Email  abandopa@iitk.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Lasure 
Designation  CSO 
Affiliation  Intignus Biotech Pvt Ltd 
Address  Lab 6, 400 NIP, NCL Innovation Park, Dr. Homi Bhabha Road, Pashan, Pune

Pune
MAHARASHTRA
411008
India 
Phone  9923141484  
Fax    
Email  nehalasure@intignusbiotech.com  
 
Details of Contact Person
Public Query  
Name  Dr Neha Lasure 
Designation  CSO 
Affiliation  Intignus Biotech Pvt Ltd 
Address  Lab 6, 400 NIP, NCL Innovation Park, Dr. Homi Bhabha Road, Pashan, Pune

Pune
MAHARASHTRA
411008
India 
Phone  9923141484  
Fax    
Email  nehalasure@intignusbiotech.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manisha Kumar  Lady Hardinge Medical College  Department of Obstetrics and gynecology,Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi
New Delhi
DELHI 		 9818014887

manishaonly@gmail.com 
Dr Sumitra Bachani  VMMC and Safdarjung Hospital  Department of Obstetrics and Gynecology, ground floor, Gate 3, H693+H6W, NH 48, near AIIMS Hospital, Ansari Nagar West, New Delhi
New Delhi
DELHI 		 9212129161

sumitrabachani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee VMMC and Safdarjung hospital  Approved 
LHMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O14||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  50.00 Year(s)
Gender  Female 
Details  Pregnant women having gestational age between 11 to 16 weeks from LMP and/or CRL 
 
ExclusionCriteria 
Details  Unconscious or severely ill status
Having major fetal abnormality identified at the time of enrollment
Known bleeding disorder such as von Willebrand’s disease
Participation in another drug trial within 28 days before screening
Pregnant women diagnosed with Preeclampsia
Pregnant women who are already on aspirin medication
Pregnant women with a known case of diabetes or chronic HTN
Twins or multiple pregnancies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the Diagnostic Accuracy of the Preeclampsia screening test  At 6 time points of testing during the study (gestational age)
1. 11 to 12 weeks ± 6 days
2. 13 to 15 weeks ± 6 days
3. 16 to 19 weeks ± 6 days
4. 20 to 28 weeks ± 6 days
5. 28 to 34 weeks ± 6 days
6. after 35 weeks ± 0 days 
 
Secondary Outcome  
Outcome  TimePoints 
Using patient history and other clinical findings (MAP, USG findings, maternal factors) and combinations for enhanced diagnostic accuracy  6 time points 
Association of risk factors with Preeclampsia  6 time points 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
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)   01/09/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Preeclampsia (PE) is a potentially fatal condition affecting pregnant women and the fetus during pregnancy and/or postpartum. An ability to predict and determine preeclampsia risk will change the way doctors manage the disease and help improve health outcomes for both the mother and the baby. 
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