| 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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [karnadpooja@gmail.com].
- 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.
- 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.
|