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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01092949
First received: February 26, 2010
Last updated: January 2, 2014
Last verified: March 2012
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Comparison between the two measurements methods. [ Time Frame: 45 MIN ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: February 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092949

Contacts
Contact: Laurent Salomon, MCU PH +33(0)1 44 49 40 30 ext +33 laurentsalomon@gmail.com

Locations
France
Necker Enfants Malades Recruiting
Paris, France, 75015
Contact: LAURENT SALOMON, MCU PH    (1)44 49 40 30 ext +33    laurentsalomon@gmail.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent Salomon, MCU PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01092949     History of Changes
Other Study ID Numbers: P 081111, 2009-A01024-63
Study First Received: February 26, 2010
Last Updated: January 2, 2014
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on July 24, 2014