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Completed

NCT Number: NCT01092949

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

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.

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Key information

Conditions

Placental Insufficiency Female Urogenital Diseases and Pregnancy Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Necker Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Device

MRI, 45 minutes

Other names: MRI, 45 minutes

Primary outcomes

  1. Establishment of physiological reference range of placental perfusion

    Time frame: 45 MIN

    Establishment of physiological reference range of placental perfusion

Secondary outcomes

  1. 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

  2. Comparison between the two measurements methods.

    Time frame: 45 MIN

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2010
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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