| CTRI Number |
CTRI/2025/03/081648 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Using a Mobile App to track baby growth during pregnancy and study health outcomes at birth |
|
Scientific Title of Study
|
Monitoring of Fetal Growth Parameters using mobile application and Analysis of perinatal outcomes of fetuses between 10th and 90th centile : A Prospective Study |
| 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 Shilpalakshmi Prasad E |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Labor ward -150, Department of Obstetrics and Gynaecology, Saveetha Medical College And Hospitals, Thandalam Chennai, Tamil Nadu, India.
Chennai
TAMIL NADU
602105
India |
| Phone |
9094550660 |
| Fax |
|
| Email |
shilpaprasad92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanthi E |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Labor ward -150, Department of Obstetrics and Gynaecology, Saveetha Medical College And Hospitals, Thandalam Chennai, Tamil Nadu, India.
Chennai
TAMIL NADU
602105
India |
| Phone |
9790963795 |
| Fax |
|
| Email |
drshanthie@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpalakshmi Prasad E |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Labor ward -150, Department of Obstetrics and Gynaecology, Saveetha Medical College And Hospitals, Thandalam Chennai, Tamil Nadu, India.
Chennai
TAMIL NADU
602105
India |
| Phone |
9094550660 |
| Fax |
|
| Email |
shilpaprasad92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Institute Of Medical And Technical Sciences, Saveetha University, Saveetha nagar, Chennai, Tamil Nadu, India, 602105. |
|
|
Primary Sponsor
|
| Name |
Saveetha Institute Of Medical And Technical Sciences Saveetha University |
| Address |
Saveetha Medical College And Hospitals Thandalam Chennai Tamil Nadu India 602105 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrShanthiE |
Saveetha Institute of Medical and Technical sciences, Saveetha university |
Labor ward -150, Department of Obstetrics and Gynaecology, Saveetha Medical College And Hospitals, Thandalam Chennai, Tamil Nadu, India, 602105
Chennai
TAMIL NADU |
9790963795
drshanthie@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Instituition Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile application name : BABY PLOT |
Mobile application based Gestational age calculation and Growth chart developed Based on The World Health Organization Fetal Growth Charts published in 2017. Biometric growth parameters: calculated using UltraSound measurements. Data entered in the mobile application during each visit and growth chart with percentiles noted. Estimated Fetal Weight calculated using biometric growth parameters. This is done from 28 weeks till term gestation, done every 4 weeks , for a duration of 3 months .Postnatal parameters notes and Fetuses between 10th and 90th growth percentile included in the study for further analysis. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women aged 18-35 years. Singleton pregnancy. With at least two growth scans done after 28 weeks gestational age done in Saveetha Medical College. |
|
| ExclusionCriteria |
| Details |
Multiple gestation. Known case of any congenital anomalies. Deliveries without any prior growth scan. Growth percentile less than 10th centile. Growth percentile more than 90th centile. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze perinatal outcomes of fetuses monitored using the application. To determine if specific risk categories exist within the 10th to 90th centile range. |
Growth chart plotted and percentile noted from 28 weeks gestational age till term gestational, every 4 weeks , for a duration of 3 months . This data is correlated with immediate postnatal fetal parameters at birth. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop a mobile application for real-time monitoring of fetal growth. To assess the effectiveness of the mobile application in identifying fetuses at risk within the 10th to 90th centile range. |
24 to 40 weeks gestational age |
|
|
Target Sample Size
|
Total Sample Size="278"
Sample Size from India="278"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="0"
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
|
Mobile application based Gestational age calculation and Growth chart developed Based on The World Health Organization Fetal Growth Charts published in 2017. Biometric growth parameters: calculated using UltraSound measurements. Data entered in the mobile application during each visit and growth chart with percentiles noted. Fetuses between 10th and 90th growth percentile included in the study for further analysis based on perinatal outcome , and specific risk categories identified within the 10th and 90th centile. Mobile application End user : Obstetrician . |