Centre Hospitalier Régional Universitaire de Nancy
Vandœuvre-lès-Nancy, 54500, France
Location status: Recruiting
Recruiting
NCT Number: NCT04328532
MRI Screening of Placenta Adhesion Abnormalities
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
MRI
DeviceMRI examination (45 min max) with potential oxygen delivery for 10 min
Primary outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Central Hospital, Nancy, France
Other
Registry information
Acronym: DIANE
Important dates
- Study start
- 2020
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 31, 2020
- Registry last updated
- Jun 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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