| 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
|
|
|
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
|
|
|
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.
|