| 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
|
|
|
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
|
|
|
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. |