A Novel Approach Integrating Magnetic Resonance Imaging (MRI) Data and Artificial Intelligence for Predicting the Success Rate of Vaginal Delivery in Pregnant Women

NCT ID: NCT06044129

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study was to use MRI imaging to accurately scan the pregnant woman's pelvis and fetal skull, build a 3D model of them, and combine with artificial intelligence to develop an accurate tool to predict the success rate of vaginal delivery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vaginal Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vaginal trial labor group

Mri scan of fetal head and pelvis

Intervention Type DEVICE

The pelvic parameters and fetal head parameters of pregnant women were measured by MRI, including pelvic entrance plane, middle pelvic plane, pelvic outlet plane, pubic arch Angle, double parietal diameter, occipitofrontal diameter, and suboccipital fontanel diameter.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mri scan of fetal head and pelvis

The pelvic parameters and fetal head parameters of pregnant women were measured by MRI, including pelvic entrance plane, middle pelvic plane, pelvic outlet plane, pubic arch Angle, double parietal diameter, occipitofrontal diameter, and suboccipital fontanel diameter.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Full-term.
* Single fetus, head first.
* Pregnant women have vaginal couvade wishes.
* Complete clinical data of pregnant women.

Exclusion Criteria

* Pregnancy with serious medical and surgical diseases.
* Abnormal fetal position (such as transverse, breech, etc.).
* Twin or multiple pregnancies.
* Vaginal couvade contraindications such as placenta previa.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ying Hua

Role: CONTACT

+8613676403165 ext. +8613676403165

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAHoWMU-CR2023-07-209

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.