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Clinical Trials/CTRI/2025/03/081648
CTRI/2025/03/081648Not yet recruitingPhase 2

Monitoring of Fetal Growth Parameters using mobile application and Analysis of perinatal outcomes of fetuses between 10th and 90th centile : A Prospective Study

Saveetha Institute Of Medical And Technical Sciences Saveetha University1 site in 1 country278 target enrollmentStarted: March 17, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
278
Locations
1
Primary Endpoint
To analyze perinatal outcomes of fetuses monitored using the application. To determine if specific risk categories exist within the 10th to 90th centile range.

Study Overview

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 .

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 35.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Multiple gestation.
  • Known case of any congenital anomalies.
  • Deliveries without any prior growth scan.

Outcomes

Primary Outcomes

To analyze perinatal outcomes of fetuses monitored using the application. To determine if specific risk categories exist within the 10th to 90th centile range.

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
Saveetha Institute Of Medical And Technical Sciences Saveetha University
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Shilpalakshmi Prasad E

Saveetha Medical College and Hospital

Study Sites (1)

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