MRI Screening of Placenta Adhesion Abnormalities

NCT04328532 | Recruiting

• 1 other identifier: 2019-A02794-53
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Placenta; Implantation

Outcome Measures

Primary Outcomes (3)

• Area under the ROC curve of the T2 relaxation time mean value

  Through study completion, an average of 6 months

• Area under the ROC curve of the T2* relaxation time mean value

  Through study completion, an average of 6 months

• Area under the ROC curve of the Apparent Diffusion Coefficient mean value

  Through study completion, an average of 6 months

Study Arms (1)

Pregnancy with risk factors for PPA

EXPERIMENTAL

Device: MRI

Interventions

MRI DEVICE

MRI examination (45 min max) with potential oxygen delivery for 10 min

Pregnancy with risk factors for PPA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Central Study Contacts

Charline BERTHOLDT, MI

CONTACT

+33 3 83 34 43 12; c.bertholdt@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Prospective interventional clinical cohort study, monocentric, controlled, open.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 31, 2020
• Study Start: October 21, 2020
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): October 21, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

FR (1)