CTRI Number |
CTRI/2021/12/038654 [Registered on: 15/12/2021] Trial Registered Prospectively |
Last Modified On: |
15/12/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
Developing Artificial Intelligence Based solutions to predict preterm delivery and related adverse outcome to baby |
Scientific Title of Study
|
DATA ACQUISITION STUDY FOR DEVELOPING AI (Artificial Intelligence) ALGORITHMS TO PREDICT PRETERM LABOR AND ADVERSE PERINATAL OUTCOME |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Akhila Vasudeva |
Designation |
Professor in OBG, Kasturba Medical College, Manipal, MAHE |
Affiliation |
Kasturba Medical College, Manipal, MAHE |
Address |
Professor and Unit Chief in Department of OBG.
Chief consultant - Division of Fetal Medicine
Kasturba Medical College, Manipal
MAHE
Pin 576104
India
Udupi KARNATAKA 576104 India |
Phone |
9591614792 |
Fax |
|
Email |
akhila.vasudeva@manipal.edu |
|
Details of Contact Person Scientific Query
|
Name |
Akhila Vasudeva |
Designation |
Professor in OBG, Kasturba Medical College, Manipal, MAHE |
Affiliation |
Kasturba Medical College, Manipal, MAHE |
Address |
Professor and Unit Chief in Department of OBG.
Chief consultant - Division of Fetal Medicine
Kasturba Medical College, Manipal
MAHE
Pin 576104
India
Udupi KARNATAKA 576104 India |
Phone |
9591614792 |
Fax |
|
Email |
akhila.vasudeva@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Akhila Vasudeva |
Designation |
Professor in OBG, Kasturba Medical College, Manipal, MAHE |
Affiliation |
Kasturba Medical College, Manipal, MAHE |
Address |
Professor and Unit Chief in Department of OBG.
Chief consultant - Division of Fetal Medicine
Kasturba Medical College, Manipal
MAHE
Pin 576104
India
Udupi KARNATAKA 576104 India |
Phone |
9591614792 |
Fax |
|
Email |
akhila.vasudeva@manipal.edu |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Philips Research |
Address |
Philips Research,
Philips Innovation Campus -Bangalore
Manyata Tech Park, Outer Ring Rd, Manyata Tech Park, Nagavara, Bengaluru, Karnataka 560045
Phone: 080 4189 0000
e-mail: arun.shastry@philips.com |
Type of Sponsor |
Other [Corporate Research] |
|
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 |
Akhila Vasudeva |
Department of OBG,KMC Manipal, MAHE |
Department of Obstetrics and Gynecology
Manipal
576104 Udupi KARNATAKA |
9591614792
akhila.vasudeva@manipal.edu |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O429||Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Female |
Details |
1.Adult (>18 years) pregnant women (from 26th week of gestation), who have regular antenatal care at Department of OBG, KMC Manipal, willing and able to provide informed consent. |
|
ExclusionCriteria |
Details |
1.Pregnant women aged < 18 years.
2.Women admitted to labour room/HDU/ICU due to obstetric/non-obstetric problem
3.Women in need of emergency management
4.Critical non-pregnancy related health issues (Road traffic accidents etc.)
5.Currently displaying COVID-19-related symptoms, namely fever, cough and/or difficulty breathing or having been positively tested as infected with COVID-19 in the past 14 days. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Primary outcome that the study intends to predict is preterm labour, delivery and the related adverse perinatal outcome. Using the acquired data from relevant clinical details, lab and imaging data, as well as regularly performed NSTs – It is intended to develop a predictive AI model in order to predict the occurrence of preterm labour, delivery and the related adverse perinatal outcome. Study aims to develop as well as test the accuracy of such a predictive AI model in terms of sensitivity, specificity, positive and negative predictive value. |
3 years |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="1500" Sample Size from India="1500"
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)
|
24/12/2021 |
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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
This study aims to acquire data from around 1500 unselected pregnant women attending antenetal OPD in a tertiary care referral center in South India (single center). Data acquired includes risk factors from history, examination, blood/urine reports, Ultrasound reports - all relevant to prediction of preterm labour. In addition, regularly performed Non-stress tests and uterine activity monitoring are digitally captured during their antenatal visits at or beyond 26 weeks of pregnancy. Once data is collected, study aims to develop and test Artificial Intelligence Algorithms to predict preterm labour in obstetric population.
Preterm labour/delivery (PTL/PTD) is a major health burden and contributes significantly to perinatal mortality/morbidity as well as long term health problems in the children. With a worldwide prevalence of 5-18%, it is an urgent need to predict and prevent preterm delivery. Multiple individual risk factors and risk scoring algorithms have been developed to predict PTL/PTD but none have reached a level of accuracy to be able to be employ in general obstetric practice. In addition, over half of PTD occur in women with no apparent risk factors. Complex interplay of risk factors is also a well-known phenomenon – which is difficult to be interpreted during routine obstetric practice. Hence this study aims to see if incorporating all these multiple risk factors in addition to periodic observation of fetal heart rate/uterine activity patterns – into an AI tool – to see if we can develop a prediction model for preterm delivery that has a better prediction value than the multiple existing risk factors/risk scoring systems. A large data set on fetal heart rate pattern along with uterine activity has not so far been studied by an AI algorithm in an attempt to predict preterm delivery. Also, incorporating multiple clinical, laboratory, imaging parameters to fetal heart+uterine activity patterns may help us develop a more robust tool to predict PTL/PTD - this information is not available in clinical literature. An accurate prediction may help employ preventive interventions in a suitable subset of vulnerable pregnant women in order to prevent PTL/PTD. |