Actively Recruiting
MRI Screening of Placenta Adhesion Abnormalities
Led by Central Hospital, Nancy, France · Updated on 2025-02-13
71
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Placenta Adhesion Abnormalities (PAA) occur when the placenta invades too deeply into the uterine muscle, which can lead to serious complications like heavy bleeding, hysterectomy, and even maternal death, especially if discovered during delivery. This study aims to evaluate the use of quantitative MRI techniques without gadolinium contrast to better detect PAA in pregnant women between 30 and 38 weeks gestation who have risk factors for this condition. It compares these MRI measurements to standard ultrasound methods to improve diagnosis. Participants will undergo an MRI exam lasting up to 45 minutes, which may include receiving oxygen for 10 minutes during the scan. This imaging is done without contrast agents and focuses on measuring parameters such as Apparent Diffusion Coefficient, T2, and T2* relaxation times that reflect placental blood flow and oxygenation. The study involves pregnant women identified as having risk factors like low-lying placenta or placenta near a uterine scar. During the study, participants will be monitored to measure the accuracy of these MRI parameters in detecting PAA, using the area under the ROC curve as the primary outcome over about six months. All participants must have completed a preliminary medical exam and given informed consent. The study is sponsored by Central Hospital in Nancy, France, and participants plan to deliver there. Safety and study progress will be followed through the study completion period.
CONDITIONS
Brief Title
MRI Screening of Placenta Adhesion Abnormalities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant participant between 30 and 38 weeks of gestation
- Age 18 years or older
- Completed the preliminary medical examination
- Received full information about the study and signed informed consent
- Planning to give birth at Central Hospital Nancy
- Presenting risk factors for placenta adhesion abnormalities such as low-lying placenta or placenta near a uterine scar
You will not qualify if you...
- Multiple pregnancy
- Any contraindication or restriction to MRI according to current recommendations
- Unable to understand or follow study procedures
- Person referred to in Articles L. 1121-6 to L. 1121-8, L1122-2 and L. 1122-1-2 of the Public Health Code
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo an MRI examination to screen for placenta adhesion abnormalities.
1 visit (in-person)
Duration - Approximately 6 months
Participants are monitored through study completion to evaluate MRI diagnostic outcomes.
Visits as needed for study follow-up
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Régional Universitaire de Nancy
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
Research Team
C
Charline BERTHOLDT, MI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Frequently Asked Questions
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