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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092949
First Posted: March 25, 2010
Last Update Posted: April 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Placental Insufficiency Device: MRI

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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


Secondary Outcome 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 ]

Enrollment: 135
Study Start Date: February 2010
Estimated Study Completion Date: September 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MRI
    MRI, 45 minutes
    Other Name: MRI, 45 minutes
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092949


Locations
France
Necker Enfants Malades
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent Salomon, MCU PH Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01092949     History of Changes
Other Study ID Numbers: P 081111
2009-A01024-63 ( Registry Identifier: IDRCB )
First Submitted: February 26, 2010
First Posted: March 25, 2010
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Placenta
perfusion
MRI
spin tagging
Gadolinium
placental insufficiency
urinary tract, sexual organs and pregnancy conditions

Additional relevant MeSH terms:
Placental Insufficiency
Placenta Diseases
Pregnancy Complications


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