MRI Screening of Placenta Adhesion Abnormalities (DIANE)

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.

Study Overview

• Status: Recruiting
• Conditions: Placenta; Implantation
• Intervention / Treatment: Device: MRI

• Study Type: Interventional
• Enrollment (Estimated): 71
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charline BERTHOLDT, MI; Phone Number: +33 3 83 34 43 12; Email: c.bertholdt@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54500
    • Recruiting
    • Centre Hospitalier Régional Universitaire de Nancy
    • Contact: Charline BERTHOLDT, MI; Phone Number: +33 3 83 34 43 12; Email: c.bertholdt@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant participant between 30 and 38 weeks of gestation,
• Age ≥18 years old,
• Participant who completed the preliminary medical examination,
• Participant who has received full information about the organization of the research and has signed her informed consent.
• Participant planning to give birth at CHRU of Nancy
• Participant presenting risk factors for PAA : low-lying or covering placenta or in front of the uterine scar.

Exclusion Criteria:

• Multiple pregnancy,
• Participant presenting at least one contraindication or restriction to performing an MRI as described in the protocol, in accordance with the current recommendations,
• Participant unable to understand or follow study procedure,
• Person referred to in Articles L. 1121-6 to L. 1121-8, L1122-2 and L. 1122-1-2 of the Public Health Code.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregnancy with risk factors for PPA	Device: MRI; MRI examination (45 min max) with potential oxygen delivery for 10 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): October 21, 2026

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2019-A02794-53

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No