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MRI Screening of Placenta Adhesion Abnormalities

Study acronym: DIANE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. 2 versions Re-verified since Feb 11, 2025, no change to tracked fieldsv8-v9
  2. Primary and study completion dates: Oct 21, 2024 to Oct 21, 2026
    • Eligibility criteria shortened, about 2 words
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Eligibility criteria shortened, about 49 words
    • Study arms: 2 to 1
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Oct 1, 2024 to Oct 21, 2024
    • Start date changed from estimate of Oct 1, 2020 to Oct 21, 2020
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Sep 1, 2020 to Oct 1, 2020
    • Primary and study completion dates: Sep 1, 2024 to Oct 1, 2024
    v3
  2. Start date: May 1, 2020 to Sep 1, 2020
    • Primary endpoints: 4 to 3
    • Primary and study completion dates: Mar 7, 2024 to Sep 1, 2024
    • Eligibility criteria expanded, about 9 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04328532
Lead Sponsor Central Hospital, Nancy, France
Conditions
(from sponsor)		 Placenta; Implantation
Enrollment 71 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov