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NCT04328532: DIANE

MRI Screening of Placenta Adhesion Abnormalities

Recruiting now NA Last updated 13 February 2025
What this trial tests

NA trial testing MRI in Placenta; Implantation in 71 participants. Currently enrolling.

Timeline
21 October 2020
Primary endpoint
21 October 2026
21 October 2026

Quick facts

Lead sponsorCentral Hospital, Nancy, France
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment71
Start date21 October 2020
Primary completion21 October 2026
Estimated completion21 October 2026
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, female only, with Placenta; Implantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Performance of antenatal imaging to predict placenta accreta spectrum degree of severity.
    Morel O, van Beekhuizen HJ, Braun T, Collins S, et al · · 2021 · cited 21× · PMID 33811333 · DOI 10.1111/aogs.14112

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Data sources for this page

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