Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID04328532

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 day

Participants undergo an MRI examination to screen for placenta adhesion abnormalities.

1 visit (in-person)

Long-term Monitoring

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

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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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