| 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
|
|
|
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
|
|
|
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: The prediction will help us in categorizing a patient with potential fetal distress, hereby helping the doctor in taking a faster-informed decision. The outcome will also be able to help in improving the accuracy of the predictive model |