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MRI Screening of Placenta Adhesion Abnormalities (DIANE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328532
Recruitment Status : Not yet recruiting
First Posted : March 31, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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 (Blood-Oxygen-Level Dependent signal, 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.


Condition or disease Intervention/treatment Phase
Placenta; Implantation Device: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective interventional clinical cohort study, monocentric, controlled, non-randomized, open.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI Screening of Placenta Adhesion Abnormalities
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : March 7, 2024
Estimated Study Completion Date : March 7, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Pregnancy with suspicion of PAA Device: MRI
MRI examination (45 min max) with oxygen delivery for 10 min

Pregnancy without suspicion of PAA Device: MRI
MRI examination (45 min max) with oxygen delivery for 10 min




Primary Outcome Measures :
  1. Area under the Receiver Operating Characteristic (ROC) curve of the Blood-Oxygen-Level Dependent mean value [ Time Frame: Through study completion, an average of 6 months ]
  2. Area under the ROC curve of the T2 relaxation time mean value [ Time Frame: Through study completion, an average of 6 months ]
  3. Area under the ROC curve of the T2* relaxation time mean value [ Time Frame: Through study completion, an average of 6 months ]
  4. Area under the ROC curve of the Apparent Diffusion Coefficient mean value [ Time Frame: Through study completion, an average of 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Additional criteria for participants in the "Pregnancy without suspicion of PAA" group:

  • Multiparous participant (having had at least one childbirth),
  • Participant presenting one of the risk factors for PAA (low-lying or covering placenta discovered during routine ultrasound) but without uterine scar.

Additional criteria for participants in the "Pregnancy with suspicion of PAA" group:

  • Participant with a low-lying or covering placenta discovered during routine ultrasound,
  • Participant with a 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04328532


Contacts
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Contact: Charline BERTHOLDT, MI +33 3 83 34 43 12 c.bertholdt@chru-nancy.fr

Locations
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France
Centre Hospitalier Régional Universitaire de Nancy
Vandœuvre-lès-Nancy, France, 54500
Contact: Charline BERTHOLDT, MI    +33 3 83 34 43 12    c.bertholdt@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04328532    
Other Study ID Numbers: 2019-A02794-53
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Abnormalities