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

NCT06044129 | Not Yet Recruiting

• 1 other identifier: SAHoWMU-CR2023-07-209
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Delivery

Outcome Measures

Primary Outcomes (1)

• The mode of delivery

  Vaginal or cesarean delivery in the end

  during delivery

Study Arms (1)

Vaginal trial labor group

Device: Mri scan of fetal head and pelvis

Interventions

Mri scan of fetal head and pelvis 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.

Vaginal trial labor group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

Central Study Contacts

Ying Hua

CONTACT

+8613676403165; wzfeyhy1015@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)