Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE

Overview

To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2018

Detailed Description

Objective: To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center. Method: All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study. 120 patients will be included. 15 per group of weeks of gestation: 16+0-17+6 SA, 18+0-19+6 SA, 20+0-21+6 SA, 22+0-23+6 SA, 24+0-25+6 SA, 26+0-27+6 SA, 28+0-29+6 SA, 30+0-31+6 WG. MRI will be performed in the same hospital, during hospital stay, within 45 minutes. Two MRI sequences will be used to measure placental perfusion: – dynamic sequences using Gd contrast agent. – " spin tagging ", which do not need any contrast agent. Perfusion will be modelled using compartmental analysis. Reference ranges will be build up by statistical modelling. Gadolinium assays will be performed on amniotic fluid and placental tissue following TOP. Duration of inclusion: 24 months. Duration of patient participation: 45 minutes. Expected results: – Feasibility in routine practice. – Reference ranges for placental perfusion. – Comparison between the two measurements methods. Adverse outcome measure: Nausea, vomiting, lack of comfort and other adverse outcome.

Interventions

  • Device: MRI
    • MRI, 45 minutes

Clinical Trial Outcome Measures

Primary Measures

  • Establishment of physiological reference range of placental perfusion
    • Time Frame: 45 MIN
    • Establishment of physiological reference range of placental perfusion

Secondary Measures

  • To quantify in vivo and by a not invasive way the microscopic physiological phenomena relative to the placental perfusion and in the local transcapillary exchanges of the placenta
    • Time Frame: 45 MIN
  • Comparison between the two measurements methods.
    • Time Frame: 45 MIN

Participating in This Clinical Trial

Inclusion Criteria

  • Women > 18 years, – Undergoing TOP for fetal reason, – Informed signed consent. Exclusion Criteria:

  • Placental adhesion anomaly, – Growth restriction, – Contrast agent allergy, – Absent consent, – Contraindication of MRI or Gadolinium, – Renal insufficiency, – Placental abnormality at pathological examination.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Laurent Salomon, MCU PH, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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