Vaginal DeliveryNCT06044129
A Novel Approach Integrating Magnetic Resonance Imaging (MRI) Data and Artificial Intelligence for Predicting the Success Rate of Vaginal Delivery in Pregnant Women
An observational study of Vaginal Delivery, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Delivery
- What is being tested?
- Mri scan of fetal head and pelvis
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Full-term.
- Single fetus, head first.
- Pregnant women have vaginal couvade wishes.
- Complete clinical data of pregnant women.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
About this study
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
- Being tested
- Mri scan of fetal head and pelvis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mri scan of fetal head and pelvisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal trial labor group | Not described Receives: Device: Mri scan of fetal head and pelvis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mode of delivery
Vaginal or cesarean delivery in the end
Measured: during delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DeliveryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044129
- Sponsor's protocol ID
- SAHoWMU-CR2023-07-209
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06044129
- Acronym / sponsor ID
- SAHoWMU-CR2023-07-209
- Conditions
- Vaginal Delivery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal trial labor group | – | Device: Mri scan of fetal head and pelvis |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- Full-term.
- Single fetus, head first.
- Pregnant women have vaginal couvade wishes.
- Complete clinical data of pregnant women.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mri scan of fetal head and pelvisThe 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. | Device | Vaginal trial labor group |
Primary outcome
The mode of delivery
Time frame: during delivery
Vaginal or cesarean delivery in the end
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Delivery, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Hua (+8613676403165 ext. +8613676403165, wzfeyhy1015@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mode of delivery (time frame: during delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.