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

September 12, 2023 updated by: Second Affiliated Hospital of Wenzhou Medical University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Full-term single live pregnant women who gave birth in the Department of Obstetrics of the Second Affiliated Hospital of Wenzhou Medical University from January 1, 2024 to December 31, 2026 were selected as the study population

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaginal trial labor group
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mode of delivery
Time Frame: during delivery
Vaginal or cesarean delivery in the end
during delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SAHoWMU-CR2023-07-209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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