DIANE: MRI Screening of Placenta Adhesion Abnormalities

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT04328532

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Placenta; Implantation	Device: MRI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

71 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective interventional clinical cohort study, monocentric, controlled, open.Prospective interventional clinical cohort study, monocentric, controlled, open.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

MRI Screening of Placenta Adhesion Abnormalities

Actual Study Start Date :

Oct 21, 2020

Anticipated Primary Completion Date :

Oct 21, 2024

Anticipated Study Completion Date :

Oct 21, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pregnancy with risk factors for PPA	Device: MRI MRI examination (45 min max) with potential oxygen delivery for 10 min

Arm

Intervention/Treatment

Experimental: Pregnancy with risk factors for PPA

Device: MRI

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 discovered during routine ultrasound and with an 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Régional Universitaire de Nancy	Vandœuvre-lès-Nancy		France	54500

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BERTHOLDT Charline, Doctor, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT04328532

Other Study ID Numbers:

2019-A02794-53

First Posted:

Mar 31, 2020

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Congenital Abnormalities

Study Results

No Results Posted as of Mar 29, 2022