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CTRI Number  CTRI/2021/05/033674 [Registered on: 18/05/2021] Trial Registered Prospectively
Last Modified On: 17/05/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prediction of fetal distress by validating Artificial Intelligence based Software 
Scientific Title of Study   Validation of Artificial Intelligence based Software in prediction of fetal distress  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AIIMS/pat/IEC/2020/629  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun Agarwal 
Designation  Director 
Affiliation  Janitri Innovations Pvt. Ltd. 
Address  Janitri Innovations Private Limited, Shop No. 207, 2nd Floor, Apex Tower, Lal Kothi, Tonk Road, Jaipur RAJASTHAN

Jaipur
RAJASTHAN
302016
India 
Phone  9952279155  
Fax    
Email  arun@janitri.in  
 
Details of Contact Person
Scientific Query
 
Name  Arun Agarwal 
Designation  Director 
Affiliation  Janitri Innovations Pvt. Ltd. 
Address  Janitri Innovations Private Limited, Shop No. 207, 2nd Floor, Apex Tower, Lal Kothi, Tonk Road, Jaipur RAJASTHAN

Jaipur
RAJASTHAN
302016
India 
Phone  9952279155  
Fax    
Email  arun@janitri.in  
 
Details of Contact Person
Public Query
 
Name  Arun Agarwal 
Designation  Director 
Affiliation  Janitri Innovations Pvt. Ltd. 
Address  Janitri Innovations Private Limited, Shop No. 207, 2nd Floor, Apex Tower, Lal Kothi, Tonk Road, Jaipur RAJASTHAN

Jaipur
RAJASTHAN
302016
India 
Phone  9952279155  
Fax    
Email  arun@janitri.in  
 
Source of Monetary or Material Support  
Janitri Innovations pvt ltd 
 
Primary Sponsor  
Name  Janitri Innovations Pvt Ltd 
Address  Shop No. 207, 2nd Floor, Apex Tower, Lal Kothi, Tonk Road Jaipur RAJASTHAN 302016 India  
Type of Sponsor  Other [Private Limited Company] 
 
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 Mukta Agarwal  All India Institute of Medical Sciences, Patna  Labour room complex, department of obstetrics and Gynaecology, B1A, first floor, IPD building, Phulwarisharif
Patna
BIHAR 
9661215080

drmuktaa@aiimspatna.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O779||Labor and delivery complicated byfetal stress, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Singleton​ pregnancy with an estimated gestational age of more than 32 weeks.

 
 
ExclusionCriteria 
Details  Multiple pregnancies and Gestational age less than 32 weeks.​ 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The prediction will help us in categorizing a patient with fetal distress,
hereby helping the doctor in taking a faster-informed decision.
 
1 years 
 
Secondary Outcome  
Outcome  TimePoints 
The outcome will also be able to help in improving the accuracy of the predictive model .
If the prediction is accurate, then FHR monitoring at remote places with
trained birth attendants will also be possible.

 
1 years 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   31/05/2021 
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)?  

Response - NO
Brief Summary  

Background: Fetal distress is also known as an emergency pregnancy, labor, and delivery complication where a baby experiences oxygen deprivation. Decreased fetal movement in the womb and an abnormal fetal heart rate, abnormal amniotic fluid levels, abnormal results of biophysical profile, insufficient or excessive maternal weight gain are few signs of fetal distress. Fetal distress increases the concern of the obstetrician about the fetal condition and can help in an immediate intervention like cesarean section or instrumental vaginal delivery in order to prevent fetal death. 

Objectives: The Main aim of this study is to validate the Artificial Intelligence based Software for prediction of fetal distress.

Methods:  This is a Prospective observational study. Pregnant women will be admitted for delivery in the labor unit of Bharati Vidyapeeth Deemed University Medical College, Pune, who are willing to participate in the study. Singleton pregnancy with an estimated gestational age of more than 28 weeks will be included. Informed consent will be obtained from the patients willing to participate in the study and those satisfying the inclusion criteria.  The accuracy of prediction of fetal distress cases will be done by using a fetal monitoring device that provides a digitized data for FHR and UC directly or indirectly to the  “DAKSH” application/ dashboard from which the application will categorize the cases into 3 classes. 

Expected Outcomes: 

  1. The prediction will help us in categorizing a patient with potential fetal distress, hereby helping the doctor in taking a faster-informed decision. 

  2. The outcome will also be able to help in improving the accuracy of the predictive model 

 
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