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

Sponsor

Second Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06044129

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Delivery	Device: Mri scan of fetal head and pelvis

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

The mode of delivery [during delivery]
Vaginal or cesarean delivery in the end

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China	325027

Sponsors and Collaborators

Second Affiliated Hospital of Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital of Wenzhou Medical University

ClinicalTrials.gov Identifier:

NCT06044129

Other Study ID Numbers:

SAHoWMU-CR2023-07-209

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 21, 2023