MRI Screening of Placenta Adhesion Abnormalities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI.
- Who it may be relevant to
- Registry conditions: Placenta; Implantation. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device MRI
MRI examination (45 min max) with potential oxygen delivery for 10 min
Primary outcome measures
- Area under the ROC curve of the T2 relaxation time mean value [Time frame: Through study completion, an average of 6 months]
- Area under the ROC curve of the T2* relaxation time mean value [Time frame: Through study completion, an average of 6 months]
- Area under the ROC curve of the Apparent Diffusion Coefficient mean value [Time frame: Through study completion, an average of 6 months]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre Hospitalier Régional Universitaire de Nancy — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT04328532 · 2019-A02794-53