| CTRI Number |
CTRI/2025/08/093428 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Preeclampsia Screening During Pregnancy Using a Rapid Test: A longitudinal study |
|
Scientific Title of Study
|
A prospective longitudinal cohort study for Preeclampsia screening during pregnancy using a rapid 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 Abhijit Ambike |
| Designation |
Professor in Department of Obstetrics and Gynaecology |
| Affiliation |
Symbiosis University Hospital and Research Centre |
| Address |
Building Number 3, ground floor, clinical research department, SUHRC, Dnyan Marg, Mulshi Road, Lavale, Maharashtra
Pune
MAHARASHTRA
412115
India |
| Phone |
|
| Fax |
|
| Email |
abhijit.ambike@smcw.siu.edu.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
|
| Intignus Biotech Pvt Ltd
Lab 6, 400 NIP, NCL Innovation Park,Dr. Homi Bhabha Road, Pashan, Pune, Maharashtra, India - 411008 |
|
|
Primary Sponsor
|
| Name |
Intignus Biotech Pvt Ltd |
| Address |
Lab 6, 400 NIP, NCL Innovation Park, Dr. Homi Bhabha Road, Pashan Pune |
| Type of Sponsor |
Other [A private limited biotech company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhijit Ambike |
Symbiosis University Hospital and Research Centre |
Building Number 3, ground floor, clinical research department, SUHRC, Dnyan Marg, Mulshi Road, Lavale, Maharashtra 412115
Pune
MAHARASHTRA |
020-61930000
abhijit.ambike@smcw.siu.edu.in |
| Dr Dinesh Bhasin |
Symbiosis University Hospital and Research Centre |
Building Number 3, ground floor, clinical research department, SUHRC, Dnyan Marg, Mulshi Road, Lavale, Maharashtra 412115
Pune
MAHARASHTRA |
020-61930000
dinesh.bhasin@smcw.siu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) of Symbiosis International (Deemed) University, for Clinical Trials (CT), Bioavailability (BA) & Bioequivalence (BE) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
|
| ExclusionCriteria |
| Details |
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
4. Participation in another drug trial within 28 days before screening
5. Pregnant women diagnosed with Preeclampsia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and specificity of PEscreen in identifying women at risk of developing Preeclampsia compared to standard care of screening method |
4 time points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Using patient history and other clinical findings (MAP, USG findings, maternal factors) and combinations for enhanced diagnostic accuracy |
4 time points |
| Association of risk factors with Preeclampsia |
4 time points |
| Improved awareness among pregnant women surrounding topics of high risk pregnancies and preeclampsia |
4 time points |
|
|
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)
|
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="0"
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 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. |