Informations générales (source: ClinicalTrials.gov)
MRI Screening of Placenta Adhesion Abnormalities (DIANE)
Interventional
N/A
Central Hospital, Nancy, France (Voir sur ClinicalTrials)
octobre 2020
octobre 2026
05 avril 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Nancy - 54500 - Vandœuvre-lès-Nancy - France | Charline BERTHOLDT, MI | Contact (sur clinicalTrials) | |||
Critères
Femme
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.
- 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.
- 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.