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CTRI Number  CTRI/2024/07/070822 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   A clinical trial to compare performance of a preeclampsia screening test in pregnant women with preeclampsia and healthy pregnant women 
Scientific Title of Study   A Clinical Performance Evaluation Case-Control Study for Point-of-Care Preeclampsia Screening Kit in Pregnant Women 
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 Suhas Otiv 
Designation  Consulting Doctor 
Affiliation  KEM Hospital 
Address  Department of Obstetrics and Gynaecology, KEM Hospital, 489, Rasta Peth, Sardar Moodliar Road, Pune, Maharashtra, India

Pune
MAHARASHTRA
411011
India 
Phone    
Fax    
Email  suhasotiv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Lasure 
Designation  CSO 
Affiliation  Intignus Biotech Pvt. Ltd. 
Address  Lab L6, 400 NIP, NCL Innovation Park, Dr. Homi Bhabha Road, Pashan, Pune, India

Pune
MAHARASHTRA
411008
India 
Phone  64011026  
Fax    
Email  nehalasure@intignusbiotech.com  
 
Details of Contact Person
Public Query  
Name  Dr Neha Lasure 
Designation  CSO 
Affiliation  Intignus Biotech Pvt. Ltd. 
Address  Lab L6, 400 NIP, NCL Innovation Park, Dr. Homi Bhabha Road, Pashan, Pune, India

Pune
MAHARASHTRA
411008
India 
Phone  64011026  
Fax    
Email  nehalasure@intignusbiotech.com  
 
Source of Monetary or Material Support  
Intignus Biotech Pvt. Ltd 
 
Primary Sponsor  
Name  Intignus Biotech Pvt. Ltd 
Address  Lab L6, 400 NIP, 100, NCL Innovation Park, Dr. Homi Bhabha Road, Pashan, Pune, Maharashtra 
Type of Sponsor  Other [Private Institution] 
 
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 Suhas Otiv  KEM Hospital  Labour room, 2nd Floor, Department of Obstetrics and Gynaecology, KEM Hospital Research Centre, 489, Rasta Peth, Sardar Moodliar Road, Pune
Pune
MAHARASHTRA 		 9822091965

suhasotiv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KEM Hospital Research Centre 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  NOT APPLICABLE 
Comparator Agent  NIL  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Cases-
Pregnant women aged 18 years and above with confirmed diagnosis of preeclampsia based on ACOG guidelines
Controls-
Age and time-matched normotensive pregnant women aged 18 years and above 
 
ExclusionCriteria 
Details  Patients meeting any of the following exclusion criteria will not be eligible for participation in this study:
1. Unconscious or severely ill status
2. Having major fetal abnormality identified at the time of enrollment
3. Known bleeding disorder such as von Willebrand’s disease, peptic ulceration
4. Participation in another drug trial within 28 days before screening
5. Unable to provide written informed consent 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Sensitivity, specificity, positive/negative predictive values of Preeclampsia Screening Kit   Single Time Point 
 
Secondary Outcome  
Outcome  TimePoints 
1. Correlation of risk factor assessment between cases and controls
2. Comparison of biomarker levels detected by Preeclampsia Screening Kit and reference ELISA
 		 Single Time Point 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   29/07/2024 
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)  Open to Recruitment 
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 multisystemic pregnancy-specific disease characterized by endothelial dysfunction. This condition develops in 2% to 8% of all pregnant women and remains a major cause of maternal and perinatal morbidity and mortality worldwide. It is estimated that approximately 4 million women are diagnosed with PE each year, resulting in >70,000 deaths in women and 500,000 babies. Currently PE can be detected only after the 20th week of pregnancy on clinical manifestation of symptoms or using biomarker based tests. There is an unmet clinical need for early and point of care diagnostic tests. Early diagnosis (before 20 weeks of gestation), with the help of effective screening tests, can help the clinicians to manage PE effectively. In order to address this need, we have developed a sensitive, visual, LFA for PE screening. The purpose of this study is to evaluate the efficacy of Preeclampsia Screening Kit to reliably identify patients in early pregnancy that are at risk of developing PE. It is a comparatively economical, point-of-care, rapid test that can predict the risk of developing preeclampsia. 
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