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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.
    Sponsor: Assistance Publique - Hôpitaux de Paris

    Current Primary Outcome: Establishment of physiological reference range of placental perfusion [ Time Frame: 45 MIN ]

    Establishment of physiological reference range of placental perfusion


    Original Primary Outcome: Establisment of physiological reference range of placental perfusion [ Time Frame: 45 MIN ]

    Current Secondary Outcome:

    • 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 ]


    Original Secondary Outcome:

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


    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: February 26, 2010
    Date Started: February 2010
    Date Completion: September 2016
    Last Updated: April 18, 2016
    Last Verified: April 2016