Placenta Accreta SpectrumNCT07643090
Diagnostic Trial of a Vision Transformer-Based Ultrasound AI Model for Placenta Accreta Spectrum
An observational study of Placenta Accreta Spectrum, run by FANG HE at 1 site in China.
Trial summary
This study develops an end-to-end Vision Transformer (ViT)-based artificial intelligence system for ultrasound-based diagnosis of placenta accreta spectrum (PAS), aiming to improve the accuracy and efficiency of prenatal screening using standardized ultrasound video inputs. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Accreta Spectrum
- What is being tested?
- Vision Transformer-Based End-to-End Ultrasound Artificial Intelligence Model
- How many people
- 561 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- How long will I take part?
- 12 Months
- 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 aged 18-45 years; Gestational age between 24 and 34 weeks; Pregnant women with a history of placenta previa or with an anterior placenta.
Who may be able to join
- Pregnant women aged between 18 and 45 years;
- Gestational age between 24 and 34 weeks;
- Pregnant women with a history of placenta previa;
- Pregnant women with an anterior placenta;
- Willingness to participate in the study and provision of written informed consent.
Who cannot join
- Failure to provide written informed consent;
- Presence of severe complications that precluded continuation of pregnancy;
- Inability to comply with study procedures for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510150
Fang He, MD, PhD, +86 13724831279, Gzhefang@gzhmu.edu.cn
About this study
Official title: Diagnostic Trial of Vision Transformer-Based End-to-End Ultrasound Artificial Intelligence Model for Assisting in the Diagnosis of Placenta Accreta Spectrum Disorders: An Investigator-Initiated Prospective Clinical Study
This study develops an end-to-end Vision Transformer (ViT)-based artificial intelligence system for ultrasound-based diagnosis of placenta accreta spectrum (PAS), aiming to improve the accuracy and efficiency of prenatal screening using standardized ultrasound video inputs.
Read the detailed description
Placenta accreta spectrum (PAS) is a life-threatening obstetric disorder involving abnormal placental invasion into the uterine wall, which is associated with severe maternal and neonatal complications. Despite advances in imaging, prenatal diagnosis remains challenging due to variability in ultrasound interpretation and reliance on operator expertise.
This study will establish a standardized ultrasound video acquisition protocol and develop a deep learning-based model using Vision Transformer (ViT) architecture to process dynamic ultrasound sequences. The model will be trained using clinically confirmed postpartum outcomes as reference labels.
The diagnostic performance of the system will be systematically evaluated, with the goal of improving consistency in interpretation and supporting more efficient clinical decision-making in prenatal PAS screening.
- Conditions
- Placenta Accreta Spectrum
- Being tested
- Vision Transformer-Based End-to-End Ultrasound Artificial Intelligence Model
- Keywords
- Placenta Accreta Spectrum, Ultrasonography, Artificial Intelligence, Prenatal Diagnosis, Vision Transformer
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision Transformer-Based End-to-End Ultrasound Artificial Intelligence ModelDiagnostic test
An end-to-end ultrasound AI model based on the Vision Transformer (ViT) architecture was developed for the diagnosis of placenta accreta spectrum (PAS) using standardized ultrasound video inputs. Ultrasound Video Acquisition Protocol: With the patient in the supine position, the operator scanned the lower abdomen using a conventional grayscale probe. Video recording was performed in gray-scale mode for approximately 20-30 seconds, ensuring that the entire scanning region from the lower uterine segment to the uterine fundus was comprehensively captured.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the end-to-end Vision Transformer (ViT)-based ultrasound AI model for placenta accreta spectrum (PAS)
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC) of the model.
Measured: At delivery (following confirmation of PAS status by surgical and/or pathological findings)
Secondary outcomes (3)
Clinical Feasibility of the Standardized Ultrasound Video Recording Method
Completion Rate (Proportion of patients who successfully complete the standardized recording) and time consumption (Mean recording time)
Measured: At enrollment during the ultrasound examination
Consistency and Efficiency Between the AI Model and Physician Diagnosis
Diagnostic Consistency: Kappa coefficient used to evaluate the consistency between the AI model's diagnoses and those of experienced ultrasound physicians (Kappa > 0.75 indicates good agreement).
Measured: At enrollment during the ultrasound examination
Safety of the AI Model
False Negative Rate: Proportion of missed PAS-positive patients and the impact on patient outcomes .
Measured: At delivery, when PAS status and maternal outcomes are assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta SpectrumStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 561 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- FANG HE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, FANG HE, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643090
- Sponsor's protocol ID
- Ethics Review NO. 286A01
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Trial of Vision Transformer-Based End-to-End Ultrasound Artificial Intelligence Model for Assisting in the Diagnosis of Placenta Accreta Spectrum Disorders: An Investigator-Initiated Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07643090
- Acronym / sponsor ID
- Ethics Review NO. 286A01
- Conditions
- Placenta Accreta Spectrum
- Keywords
- Placenta Accreta Spectrum, Ultrasonography, Artificial Intelligence, Prenatal Diagnosis, Vision Transformer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 561 participants (estimated)
- Lead sponsor
- FANG HEUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jun 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 study develops an end-to-end Vision Transformer (ViT)-based artificial intelligence system for ultrasound-based diagnosis of placenta accreta spectrum (PAS), aiming to improve the accuracy and efficiency of prenatal screening using standardized ultrasound video inputs.
Detailed description
Placenta accreta spectrum (PAS) is a life-threatening obstetric disorder involving abnormal placental invasion into the uterine wall, which is associated with severe maternal and neonatal complications. Despite advances in imaging, prenatal diagnosis remains challenging due to variability in ultrasound interpretation and reliance on operator expertise.
This study will establish a standardized ultrasound video acquisition protocol and develop a deep learning-based model using Vision Transformer (ViT) architecture to process dynamic ultrasound sequences. The model will be trained using clinically confirmed postpartum outcomes as reference labels.
The diagnostic performance of the system will be systematically evaluated, with the goal of improving consistency in interpretation and supporting more efficient clinical decision-making in prenatal PAS screening.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women aged 18-45 years; Gestational age between 24 and 34 weeks; Pregnant women with a history of placenta previa or with an anterior placenta.
Key inclusion criteria (5 listed)
- Pregnant women aged between 18 and 45 years;
- Gestational age between 24 and 34 weeks;
- Pregnant women with a history of placenta previa;
- Pregnant women with an anterior placenta;
- Willingness to participate in the study and provision of written informed consent.
Key exclusion criteria (3 listed)
- Failure to provide written informed consent;
- Presence of severe complications that precluded continuation of pregnancy;
- Inability to comply with study procedures for other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vision Transformer-Based End-to-End Ultrasound Artificial Intelligence ModelAn end-to-end ultrasound AI model based on the Vision Transformer (ViT) architecture was developed for the diagnosis of placenta accreta spectrum (PAS) using standardized ultrasound video inputs. Ultrasound Video Acquisition Protocol: With the patient in the supine position, the operator scanned the lower abdomen using a conventional grayscale probe. Video recording was performed in gray-scale mode for approximately 20-30 seconds, ensuring that the entire scanning region from the lower uterine segment to the uterine fundus was comprehensively captured. | Diagnostic test | – |
Primary outcome
Diagnostic performance of the end-to-end Vision Transformer (ViT)-based ultrasound AI model for placenta accreta spectrum (PAS)
Time frame: At delivery (following confirmation of PAS status by surgical and/or pathological findings)
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC) of the model.
3 secondary outcomes
Clinical Feasibility of the Standardized Ultrasound Video Recording Method
Time frame: At enrollment during the ultrasound examination
Consistency and Efficiency Between the AI Model and Physician Diagnosis
Time frame: At enrollment during the ultrasound examination
Safety of the AI Model
Time frame: At delivery, when PAS status and maternal outcomes are assessed
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 11 Jun 2026.
- Individual participant dataSharing planned: No
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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.
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 Placenta Accreta Spectrum, run by FANG HE at 1 site in China.
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 3 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 11 Jun 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 China. 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 Fang He, M.D, PhD (+86 13724831279, Gzhefang@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the end-to-end Vision Transformer (ViT)-based ultrasound AI model for placenta accreta spectrum (PAS) (time frame: At delivery (following confirmation of PAS status by surgical and/or pathological findings)). 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 11 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.