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NCT06044129 Clinical Trial

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

Vaginal Delivery Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06044129
Other study ID # SAHoWMU-CR2023-07-209
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2026

Study information
Verified date September 2023
Source Second Affiliated Hospital of Wenzhou Medical University
Contact Ying Hua
Phone +8613676403165
Email wzfeyhy1015@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date December 31, 2026
Est. primary completion date September 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
China department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The mode of delivery Vaginal or cesarean delivery in the end during delivery
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