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CTRI Number  CTRI/2025/11/097673 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 07/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Baby Heart Beat Monitoring At Home And in Hospital For High Risk Pregnancies In North Karnataka  
Scientific Title of Study   A Randomised Controlled Study To Evaluate The Feasiblity Of Home Based Non Stress Test Monitoring With Hospital Based Non Stress Test Monitoring In High Risk Pregnancy In North Karnataka , India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Karnad  
Designation  Junior Resident  
Affiliation  Shri B M Patil Deemed To Be University  
Address  Obg Opd 2 Shri B M Patil Deemed To Be University, Medical College And Research Centre. Bangaramma Sajjan Campus, Solapur Road , Vijaypura

Bijapur
KARNATAKA
586103
India 
Phone  9373075507  
Fax    
Email  karnadpooja@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Neelamma Patil 
Designation  Proffessor  
Affiliation  Shri B M Patil Deemed To Be University  
Address  Obg Opd 2 Shri B M Patil Deemed To Be University, Medical College And Research Centre. Bangaramma Sajjan Campus, Solapur Road , Vijaypura
Obg Opd 2 Shri BM Patil Deemed To Be University, Medical College And Research Centre. Bangaramma Sajjan Campus, Solapur Road , Vijaypura
Bijapur
KARNATAKA
586103
India 
Phone  9845068074  
Fax    
Email  neelamma.patil@bldedu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Pooja Karnad  
Designation  Junior Resident  
Affiliation  Shri B M Patil Deemed To Be University  
Address  Obg Opd 2 Shri B M Patil Deemed To Be University, Medical College And Research Centre. Bangaramma Sajjan Campus, Solapur Road , Vijaypura

Bijapur
KARNATAKA
586103
India 
Phone  9373075507  
Fax    
Email  karnadpooja@gmail.com  
 
Source of Monetary or Material Support  
Shri B M Patil Medical College Deemed To Be University 
 
Primary Sponsor  
Name  Shri B M Patil Medical College Deemed To Be University  
Address  Obg Opd 2 Shri B M Patil Deemed To Be University, Medical College And Research Center. Bangaramma Sajjan Campus, Solapur Road, Vijaypura  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Shri B M Patil Medical College Deemed To Be University   Obg Opd 2 Shri B M Patil Deemed To Be University, Medical College And Research Center. Bangaramma Sajjan Campus, Solapur Road, Vijaypura  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pooja Karnad  Shri B M Patil Deemed To Be University Medical College And Research Center.  Obg Opd 2 Shri B M Patil Deemed To Be University, Medical College And Research Center. Bangaramma Sajjan Campus, Solapur Road, Vijaypura
Bijapur
KARNATAKA 
9373075507

karnadpooja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Clearance  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O092||Supervision of pregnancy with other poor reproductive or obstetric history,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Women Between The Ages Of 18 And 40 Who Presented With High-Risk Pregnancy Between 28 And 42 Weeks Of Pregnancy With A Live, Singleton Foetus.
Mild To Moderate- Fetal Growth Restriction (FGR), Oligohydramnios
Mild Preeclampsia
Gestational Diabetes Mellitus, Bad Obstetric History
Precious Pregnancy, Elderly Primigravida
Pregnancy Through Assisted Reproductive Techniques
Any One Family Member Above The Age Of 18 Years Should Know The Usage Of Any Smart Device
 
 
ExclusionCriteria 
Details  Pregnant Women Classified As Low-Risk
Known Fetal Anomalies
Patients Without Access To Necessary Technology For Remote Monitoring
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess Feasibility Of Using Home NST Machines To Hospital Based NST Machines.
Study The Perceptions Of Pregnant Women Regarding Usage Of Home NST Machine
Evaluate Patient Compliance Of Home NST Machines.
 
Home Based Monitoring for Minimum 3 days to 7 days And Hospital Based Monitoring for Minimum 3 days to 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Cost Effectiveness Of Each Method
Identify The Challenges Faced 
Home Based Monitoring for Minimum 3 days to 7 days And Hospital Based Monitoring for Minimum 3 days to 7 days 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   20/11/2025 
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="1"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [karnadpooja@gmail.com].

  6. For how long will this data be available start date provided 31-12-2026 and end date provided 31-03-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

High-risk pregnancies pose a significant challenge to maternal and fetal health, particularly in resource-limited settings such as rural India. Conditions like gestational hypertension, preeclampsia, diabetes, and fetal growth restriction require continuous monitoring to prevent adverse outcomes . Regular fetal surveillance, including the non-stress test (NST), plays a crucial role in assessing fetal well-being and detecting early signs of distress. However, access to timely and reliable NST monitoring remains a critical barrier in rural regions, where healthcare infrastructure and trained personnel are often scarce.The advent of home-based NST machines presents a promising alternative for improving fetal monitoring in high-risk pregnancies. These devices allow pregnant women to conduct fetal heart rate assessments in their own homes, potentially reducing the burden on healthcare facilities while enhancing maternal autonomy and access to care . Studies suggest that integrating home NST technology could lead to earlier detection of fetal distress, timely medical interventions, and improved pregnancy outcomes . However, challenges such as device affordability, technical feasibility, user-friendliness, and cultural acceptance remain key considerations for successful implementation .Understanding the feasibility, challenges, and perceptions of using home NST machines in rural India is crucial for assessing their potential impact on maternal and neonatal health. This qualitative study aims to explore the experiences of pregnant women, healthcare providers regarding the use of home NST technology. By examining both the opportunities and obstacles associated with its adoption, this study seeks to inform future policies and interventions that could enhance fetal monitoring and improve maternal care in resource-limited settings.

 
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