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CTRI Number  CTRI/2024/10/074871 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 29/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Research utilizing Artificial Intelligence (AI) in obstetric ultrasound to enhance the assessment of fetal biometry  
Scientific Title of Study   Use of Artificial Intelligence for the ultrasound assessment of fetal biometry - Comparison of automated to manual measurement of estimated fetal weight 
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 K Aparna Sharma 
Designation  Professor 
Affiliation  AIIMS New Delhi, Department of Obstetrics and Gynaecology 
Address  Room No. 711, Mother and Child Block, Department of Obstetrics and Gynaecology, AIIMS New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  09711824415  
Fax    
Email  kaparnasharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Aparna Sharma 
Designation  Professor 
Affiliation  AIIMS New Delhi, Department of Obstetrics and Gynaecology 
Address  Room No. 711, Mother and Child Block, Department of Obstetrics and Gynaecology, AIIMS New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  09711824415  
Fax    
Email  kaparnasharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Aparna Sharma 
Designation  Professor 
Affiliation  AIIMS New Delhi, Department of Obstetrics and Gynaecology 
Address  Room No. 711, Mother and Child Block, Department of Obstetrics and Gynaecology, AIIMS New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  09711824415  
Fax    
Email  kaparnasharma@gmail.com  
 
Source of Monetary or Material Support  
Mother and Child Block, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Dr K Aparna Sharma  All India Institute of Medical Sciences, New Delhi  Mother and Child Block,Department of Obstetrics and Gynaecology, AIIMS New Delhi, Ansari Nagar-110029
South
DELHI 
09711824415

kaparnasharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee All India Institute Of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. Singleton, monochorionic diamniotic (MCDA) and dichorionic diamniotic (DCDA) twin pregnancies
2. Between 28 and 42 weeks of gestation
3. Maternal age more than 18 years
 
 
ExclusionCriteria 
Details  a)Monochorionic monoamniotic twin pregnancies
b) Major fetal structural anomalies or aneuploidies c) Spontaneous or preterm premature rupture of membranes
d) Maternal age less than 18 years
e) Unable to give informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Birthweight  At the time of Delivery 
 
Secondary Outcome  
Outcome  TimePoints 
a) Accuracy of manual or automated biometric measurements in singleton & in twin pregnancies compared to birthweight
b) Duration of biometry performed manually versus automated in singleton compared to twin pregnancies
c) Evaluation of factors affecting image quality & accuracy of ultrasound estimation of fetal weight: maternal BMI, gestational age, amniotic fluid level measured by deepest vertical pocket (DVP)
 
Between 36 & 42 weeks of gestation 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/10/2024 
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 Yet Recruiting 
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  

Obstetric ultrasound, a non-invasive and cost-effective imaging technique, plays a pivotal role in assessing fetal biometry for evaluating growth and well-being during pregnancy. Accurate estimation of fetal weight is crucial for determining appropriate obstetric management. The standard procedure involves measuring biparietal diameter, head circumference, abdominal circumference, and femur length, but it is subject to variability and dependence on operator expertise.

Addressing these challenges, the application of artificial intelligence (AI) in obstetric ultrasound has emerged. AI, particularly machine learning algorithms, is increasingly employed to automate fetal biometry on standardized planes, potentially minimizing variability and enhancing efficiency. These algorithms analyze ultrasound images, extracting relevant features to estimate fetal weight. The use of deep learning architectures, such as convolutional neural networks (CNNs), has shown promising results. By leveraging machine learning and deep learning techniques, these systems aim to provide more reliable predictions of fetal weight, contributing to enhanced monitoring and management of pregnancy. The potential benefits include increased efficiency, reduced observer-dependency, and improved precision in assessing fetal growth and well-being. However, integration into clinical practice requires rigorous testing, validation, regulatory approval, and acceptance by healthcare professionals.

 
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