MRI Screening of Placenta Adhesion Abnormalities (DIANE)
Primary Purpose
Placenta; Implantation
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Placenta; Implantation
Eligibility Criteria
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 discovered during routine ultrasound and with an 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.
Sites / Locations
- Centre Hospitalier Régional Universitaire de NancyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pregnancy with risk factors for PPA
Arm Description
Outcomes
Primary Outcome Measures
Area under the ROC curve of the T2 relaxation time mean value
Area under the ROC curve of the T2* relaxation time mean value
Area under the ROC curve of the Apparent Diffusion Coefficient mean value
Secondary Outcome Measures
Full Information
NCT ID
NCT04328532
First Posted
February 27, 2020
Last Updated
August 29, 2023
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT04328532
Brief Title
MRI Screening of Placenta Adhesion Abnormalities
Acronym
DIANE
Official Title
MRI Screening of Placenta Adhesion Abnormalities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
October 21, 2024 (Anticipated)
Study Completion Date
October 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta; Implantation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective interventional clinical cohort study, monocentric, controlled, open.
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pregnancy with risk factors for PPA
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI examination (45 min max) with potential oxygen delivery for 10 min
Primary Outcome Measure Information:
Title
Area under the ROC curve of the T2 relaxation time mean value
Time Frame
Through study completion, an average of 6 months
Title
Area under the ROC curve of the T2* relaxation time mean value
Time Frame
Through study completion, an average of 6 months
Title
Area under the ROC curve of the Apparent Diffusion Coefficient mean value
Time Frame
Through study completion, an average of 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 discovered during routine ultrasound and with an 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charline BERTHOLDT, MI
Phone
+33 3 83 34 43 12
Email
c.bertholdt@chru-nancy.fr
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Nancy
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charline BERTHOLDT, MI
Phone
+33 3 83 34 43 12
Email
c.bertholdt@chru-nancy.fr
12. IPD Sharing Statement
Learn more about this trial
MRI Screening of Placenta Adhesion Abnormalities
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