MRI Screening of Placenta Adhesion Abnormalities

Condition(s) studied

Investigational drug(s) / intervention(s)

MRI: MRI examination (45 min max) with potential oxygen delivery for 10 min

Study summary

Placenta Adhesion Abnormalities (PAA) are the consequence of an excessive invasion of the placenta within the myometrium. PAA are related to severe maternal pregnancy outcomes, especially in case of incidental discovery during delivery that increase the risk of intraoperative massive bleeding, hysterectomy and even maternal death. Ultrasound is the standard modality for diagnosing PAA, but Magnetic Resonance Imaging (MRI) has been increasingly performed in the case of inconclusive sonographic findings. However, standard morphological MRI sequences appear as insufficient to improve the sensitivity and specificity values for detecting PAA, while quantitative MRI may be more efficient.

The main objective of this study is to characterize the diagnostic performance of quantitative MRI parameters (mainly Apparent Diffusion Coefficient, T2 and T2\*) reflecting placental perfusion and/or oxygenation at high field, without injection of gadolinium-based agent, for the detection of PAA in women with ongoing pregnancy between 30 and 38 weeks of gestation with risk factors for PPA.

Eligibility

Primary outcome measure(s)

• Area under the ROC curve of the T2 relaxation time mean value — Through study completion, an average of 6 months
• Area under the ROC curve of the T2* relaxation time mean value — Through study completion, an average of 6 months
• Area under the ROC curve of the Apparent Diffusion Coefficient mean value — Through study completion, an average of 6 months

Trial sites (1)

More Central Hospital, Nancy, France trials in France