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Evaluation of Fetoplacental Oxygenation With Functional MRI in Pregnant Women (BOLD-FP)

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.
 
ClinicalTrials.gov Identifier: NCT02238301
Recruitment Status : Active, not recruiting
First Posted : September 12, 2014
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to evaluate the use of functional MRI in pregnant women as a non-invasive diagnostic tool to detect placental insufficiency and differentiate healthy fetuses from the intra-uterine growth restricted ones. Functional MRI in pregnant women can detect a variation of the MRI signal (called BOLD effect) from the placenta and the fetus when the mother is breathing pure oxygen. This study aims hence to demonstrate the difference in the BOLD effect between normal feto-placental units and growth restricted ones.

Condition or disease Intervention/treatment Phase
Intrauterine Growth Restriction Other: Bold sequence patients test Other: Bold + ASL sequence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of the Fetoplacental BOLD Effect in Pregnant Women Using Functional MRI
Actual Study Start Date : February 18, 2015
Actual Primary Completion Date : September 26, 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Patients "test" (pregnant women with a eutrophic fetus)
Test the type of mask, oxygen flow and duration of oxygenation, adjustment of MRI machine Adjustment of MRI machine (choice of antenna calibration, verifying Settings of each sequence, adaptation of the number of cuts for the duration of each sequence, checking the correct execution of the succession of sequences, settings of total examination time)
Other: Bold sequence patients test
Develop the hyperventilation protocol (speed, duration ...) and the choice of type of mask oxygenation better tolerated by patients. Sequences beginning with a low oxygen flow (2L/mn) then progressively increasing to obtain the BOLD effect required

Active Comparator: Pregnant women with a diagnosis of IUGR fetuses
Measure of the BOLD effect in the feto-placental units of IUGR fetuses
Other: Bold + ASL sequence

A first sequence BOLD+ASL will be launched in ambient air. The second sequence is repeated BOLD 5 minutes after power maternal hyperventilation.

Sequences will focus on the fetus and placenta but will also include maternal liver to validate maternal hyperoxygenation.


Active Comparator: Pregnant women with eutrophic fetuses
Measure of BOLD effects of fetal-placental unit eutrophic fetuses
Other: Bold + ASL sequence

A first sequence BOLD+ASL will be launched in ambient air. The second sequence is repeated BOLD 5 minutes after power maternal hyperventilation.

Sequences will focus on the fetus and placenta but will also include maternal liver to validate maternal hyperoxygenation.





Primary Outcome Measures :
  1. Highlight a placental BOLD effect [ Time Frame: at inclusion ]
    Measured as the difference between the T2* of the placenta under the ambient air and under hyperoxygenation.


Secondary Outcome Measures :
  1. Number of patients with positive difference of signal intensity of maternal liver, under the ambient air and under hyperoxygenation [ Time Frame: at inclusion ]
  2. BOLD effect in the fetal liver and brain of eutrophic fetuses [ Time Frame: at inclusion ]
    Measure the BOLD effect in the fetal liver and brain of eutrophic fetuses

  3. BOLD effect in the fetal liver and brain of IUGR fetuses [ Time Frame: at inclusion ]
    Measure the BOLD effect in the fetal liver and brain of IUGR fetuses

  4. BOLD effect in the maternal liver of IUGR fetuses [ Time Frame: at inclusion ]
    Measure a Bold effect in the maternal liver of IUGR fetuses

  5. Measure a Bold effect in the placenta of IUGR fetuses [ Time Frame: at inclusion ]
  6. Feasibility : number of possible perfusion measure [ Time Frame: at inclusion ]
  7. Feasibility : percent of possible perfusion measure [ Time Frame: at inclusion ]
  8. Compare the placental perfusion between eutrophic and RCIU fetuses [ Time Frame: at inclusion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patient
  • Patient with a singleton pregnancy
  • Patient between 18 and 37 gestational weeks
  • Informed consent signed by the patient
  • Patient affiliated to a social security scheme (beneficiary or assignee) Specific criteria for patients with a eutrophic fetus
  • Patient with fetal eutrophic on sonographic fetal weight estimation Specific criteria for patients with an IUGR-fetus Patient with a fetus presenting intra-uterine growth restriction diagnosed by ultrasound (<5th percentile).

Exclusion Criteria:

  • Patient with the usual contra-indications for MRI
  • Patient with an abdominal circumference> 125 cm
  • Patient with a multiple pregnancy
  • Patient with placenta accreta or percreta
  • Patient with a pregnancy after long history of infertility and medically assisted procreation

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): NCT02238301


Locations
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France
Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Laurent SALOMON, MD, PhD Hospital Necker - Enfants Malades - Public Hospitals of Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02238301    
Other Study ID Numbers: P130924
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: October 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Intrauterine growth restriction
BOLD effect
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes