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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

Tracking Information
First Submitted Date  ICMJE February 27, 2020
First Posted Date  ICMJE March 31, 2020
Last Update Posted Date March 31, 2020
Estimated Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date March 7, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI Screening of Placenta Adhesion Abnormalities
Official Title  ICMJE MRI Screening of Placenta Adhesion Abnormalities
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Placenta; Implantation
Intervention  ICMJE Device: MRI
MRI examination (45 min max) with oxygen delivery for 10 min
Study Arms  ICMJE
  • Experimental: Pregnancy with suspicion of PAA
    Intervention: Device: MRI
  • Pregnancy without suspicion of PAA
    Intervention: Device: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2020)
71
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 7, 2024
Estimated Primary Completion Date March 7, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charline BERTHOLDT, MI +33 3 83 34 43 12 c.bertholdt@chru-nancy.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04328532
Other Study ID Numbers  ICMJE 2019-A02794-53
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Central Hospital, Nancy, France
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP