Non-Stress Test InterpretationNCT07916090
Artificial Intelligence, Obstetricians, and Midwives in Non-Stress Test Interpretation
An observational study of Non-Stress Test Interpretation and Fetal Well-Being Assessment, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate and compare the interpretation of antenatal non-stress tests (NSTs) by three artificial intelligence models, three obstetricians, and three midwives. A total of 300 NST recordings obtained during routine antenatal care will be collected and prepared in PDF format. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Non-Stress Test Interpretation, Fetal Well-Being Assessment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women undergoing antenatal non-stress testing (NST) at the study center will constitute the study population. A total of 300 NST recordings will be collected and independently evaluated by three artificial intelligence models, three obstetricians, and three midwives. Two perinatologists will independently assess the recordings to establish the reference standard. In cases of disagreement, a third perinatologist will be consulted to determine the final reference assessment.
Who may be able to join
- Gestational age of 34+0 weeks or greater
- Singleton pregnancy undergoing routine antenatal follow-up
- Availability of an interpretable NST recording with a minimum duration of 20 minutes
- Complete clinical and demographic data
- Provision of written informed consent
Who cannot join
- Multiple pregnancy
- Major fetal congenital anomaly
- Technically uninterpretable NST recording
- NST recording shorter than 20 minutes
- Incomplete clinical data
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bilecik Training and Research Hospital
Bilecik, Bilecik, 1000
Ahmet Demirci, MD, +905418807091, ahmet.demirci@bilecik.edu.tr
About this study
Official title: Diagnostic Accuracy of Artificial Intelligence, Obstetricians, and Midwives in Non-Stress Test Interpretation: A Prospective Comparative Study
This prospective observational study aims to evaluate and compare the interpretation of antenatal non-stress tests (NSTs) by three artificial intelligence models, three obstetricians, and three midwives.
A total of 300 NST recordings obtained during routine antenatal care will be collected and prepared in PDF format. The recordings will be distributed to the evaluators, who will independently assess NST reactivity and recommend appropriate clinical management within two weeks.
Read more
Two perinatologists will independently evaluate the NST recordings to establish the reference standard. In cases of disagreement, a third perinatologist will be consulted to determine the final reference assessment.
The study will compare the diagnostic performance, agreement with the reference standard, and inter-rater agreement among artificial intelligence models, obstetricians, and midwives.
- Keywords
- Non-Stress Test, Artificial Intelligence, Obstetricians, Midwives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women Undergoing Non-Stress Testing | Pregnant women undergoing non-stress testing (NST) as part of routine antenatal care. The NST recordings will be independently evaluated by artificial intelligence models, obstetricians, and midwives, and their assessments will be compared with the reference evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement in Non-Stress Test Classification
Agreement between artificial intelligence models, obstetricians, and midwives in classifying non-stress tests (NSTs) as reactive or non-reactive will be assessed against a reference standard established by two independent perinatologists. In cases of disagreement, a third perinatologist will be consulted to determine the final reference classification. Inter-rater agreement among the evaluator groups will also be assessed.
Measured: Within 2 weeks after distribution of the 300 NST recordings to the evaluators.
Secondary outcomes (1)
Agreement in Recommended Clinical Management
Agreement between artificial intelligence models, obstetricians, and midwives regarding recommended clinical management following NST interpretation will be assessed against a reference standard established by two independent perinatologists. Disagreements will be resolved through consultation with a third perinatologist.
Measured: Within 2 weeks after distribution of the 300 NST recordings to the evaluators.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Aug 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Stress Test InterpretationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Demirci, Bilecik Seyh Edebali Universitesi
- Investigators
- Ahmet Demirci, MD, Principal investigator, Bilecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916090
- Sponsor's protocol ID
- NST-AI-2026-01
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Artificial Intelligence, Obstetricians, and Midwives in Non-Stress Test Interpretation: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07916090
- Acronym / sponsor ID
- NST-AI-2026-01
- Keywords
- Non-Stress Test, Artificial Intelligence, Obstetricians, Midwives
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study aims to evaluate and compare the interpretation of antenatal non-stress tests (NSTs) by three artificial intelligence models, three obstetricians, and three midwives.
A total of 300 NST recordings obtained during routine antenatal care will be collected and prepared in PDF format. The recordings will be distributed to the evaluators, who will independently assess NST reactivity and recommend appropriate clinical management within two weeks.
Two perinatologists will independently evaluate the NST recordings to establish the reference standard. In cases of disagreement, a third perinatologist will be consulted to determine the final reference assessment.
The study will compare the diagnostic performance, agreement with the reference standard, and inter-rater agreement among artificial intelligence models, obstetricians, and midwives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women Undergoing Non-Stress Testing | – | –Pregnant women undergoing non-stress testing (NST) as part of routine antenatal care. The NST recordings will be independently evaluated by artificial intelligence models, obstetricians, and midwives, and their assessments will be compared with the reference evaluation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women undergoing antenatal non-stress testing (NST) at the study center will constitute the study population. A total of 300 NST recordings will be collected and independently evaluated by three artificial intelligence models, three obstetricians, and three midwives. Two perinatologists will independently assess the recordings to establish the reference standard. In cases of disagreement, a third perinatologist will be consulted to determine the final reference assessment.
Key inclusion criteria (5 listed)
- Gestational age of 34+0 weeks or greater
- Singleton pregnancy undergoing routine antenatal follow-up
- Availability of an interpretable NST recording with a minimum duration of 20 minutes
- Complete clinical and demographic data
- Provision of written informed consent
Key exclusion criteria (6 listed)
- Multiple pregnancy
- Major fetal congenital anomaly
- Technically uninterpretable NST recording
- NST recording shorter than 20 minutes
- Incomplete clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement in Non-Stress Test Classification
Time frame: Within 2 weeks after distribution of the 300 NST recordings to the evaluators.
Agreement between artificial intelligence models, obstetricians, and midwives in classifying non-stress tests (NSTs) as reactive or non-reactive will be assessed against a reference standard established by two independent perinatologists. In cases of disagreement, a third perinatologist will be consulted to determine the final reference classification. Inter-rater agreement among the evaluator groups will also be assessed.
1 secondary outcome
Agreement in Recommended Clinical Management
Time frame: Within 2 weeks after distribution of the 300 NST recordings to the evaluators.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant confidentiality and data protection considerations.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmet Demirci, MD principal investigator
Bilecik Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Stress Test Interpretation and Fetal Well-Being Assessment, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Demirci, MD (+905418807091, ahmet.demirci@bilecik.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in Non-Stress Test Classification (time frame: Within 2 weeks after distribution of the 300 NST recordings to the evaluators.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.