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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  
Philips Research 
 
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  
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 
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  
Status 
Not Applicable 
 
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.
  
 
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