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CTRI Number  CTRI/2023/11/060089 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 17/11/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Development of risk stratification tool for prediction of preterm birth with Artificial intelligence.  
Scientific Title of Study   A multicentric prospective cohort study to develop Artificial intelligence-assisted risk stratification tool for prediction of preterm birth. 
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 Kavita Khoiwal 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences - Rishikesh 
Address  Department of obstetrics & gynaecology, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249201
India 
Phone  9690396908  
Fax    
Email  kavita.kh27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kavita Khoiwal 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences - Rishikesh 
Address  Department of obstetrics & gynaecology, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249201
India 
Phone  9690396908  
Fax    
Email  kavita.kh27@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kavita Khoiwal 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences - Rishikesh 
Address  Department of obstetrics & gynaecology, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249201
India 
Phone  9690396908  
Fax    
Email  kavita.kh27@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Department of Health Research, Ministry of Health and Family Welfare, Government of India, Ansari Nagar, New Delhi, India 
 
Primary Sponsor  
Name  ICMR 
Address  ICMR New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavita Khoiwal  AIIMS Rishikesh  Department of obstetrics and gynaecology AIIMS Rishikesh
Dehradun
UTTARANCHAL 
09690396908

kavita.kh27@gmail.com 
Dr Kavita Khoiwal  Community Health Centre, Doiwala  Community Health Centre, Doiwala, Dehradun
Dehradun
UTTARANCHAL 
9690396908

kavita.kh27@gmail.com 
Dr Kavita Khoiwal  Community Health Centre, Raipur  Community health centre, Raipur, Dehradun
Dehradun
UTTARANCHAL 
9690396908

kavita.kh27@gmail.com 
Dr Kavita Khoiwal  SPS Government hospital Rishikesh  SPS Government hospital, Rishikesh
Dehradun
UTTARANCHAL 
9690396908

kavita.kh27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
AIIMS Rishikesh  Approved 
AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
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  All women who had preterm birth (<37 week’s gestation) either spontaneous or induced, by vaginal route or by cesarean section were included. 
 
ExclusionCriteria 
Details  Women who had delivery <24 week and >37 weeks’ of gestation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of preterm birth in the study population.  3 years 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To describe the sociodemographic and clinical characteristics, and comorbidity of the cohort of pregnant women.
To estimate the prevalence of preterm birth in the study population.
To identify the characteristics of pregnant women with preterm birth.
To determine the risk factors and causes of preterm births. 
3 years 6 months 
 
Target Sample Size   Total Sample Size="357"
Sample Size from India="357" 
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)   01/12/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Rationale/ gaps in existing knowledge - Preterm birth is a strong predictor of neonatal morbidity and mortality. It highlights the importance of identification of high-risk pregnancies and need for development of risk stratification tools to predict the occurrence of preterm births. 

Novelty - Deep machine learning and artificial intelligence is the most recent technology and evolving nowadays. It is going to be a boom in health care system too. Development of artificial intelligence-assisted risk stratification tools to identify high-risk pregnancies and implementing these tools at community health centers will facilitate early diagnosis and timely referral, and reduce the magnitude of PTBs and other adverse obstetric outcomes too.

Objectives - The primary objective is to develop risk stratification tools for the prediction of preterm birth with the help of Artificial intelligence. And, secondary objectives are to estimate the prevalence of preterm birth in the study population and characteristics of pregnant women, risk factors, and causes of preterm births.

Methods - Approximately 5000 pregnant women will be recruited in the study to achieve a calculated sample size (preterm births) of 357 at all 4 study sites, and to be monitored till delivery. Once we finish the data collection, data will be analyzed with artificial intelligence and risk stratification tools for preterm birth prediction will be developed. 

Expected outcome - The study is expected to identify major determinants of preterm birth and to develop risk stratification tools with the help of artificial intelligence. Implementation of these tools will lead to improved health facilities and better care for pregnant women and bring about major economical benefits. Later on, we will develop an App that would be easy to use even at a primary and community health care center. Early prediction of high-risk pregnancies and timely referral would reduce neonatal morbidity and mortality significantly. 

 
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