search
Back to results

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

Primary Purpose

Intrauterine Growth Restriction

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bold sequence patients test
Bold + ASL sequence
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intrauterine Growth Restriction focused on measuring Intrauterine growth restriction, BOLD effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Patients "test" (pregnant women with a eutrophic fetus)

Pregnant women with a diagnosis of IUGR fetuses

Pregnant women with eutrophic fetuses

Arm Description

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)

Measure of the BOLD effect in the feto-placental units of IUGR fetuses

Measure of BOLD effects of fetal-placental unit eutrophic fetuses

Outcomes

Primary Outcome Measures

Highlight a placental BOLD effect
Measured as the difference between the T2* of the placenta under the ambient air and under hyperoxygenation.

Secondary Outcome Measures

Number of patients with positive difference of signal intensity of maternal liver, under the ambient air and under hyperoxygenation
BOLD effect in the fetal liver and brain of eutrophic fetuses
Measure the BOLD effect in the fetal liver and brain of eutrophic fetuses
BOLD effect in the fetal liver and brain of IUGR fetuses
Measure the BOLD effect in the fetal liver and brain of IUGR fetuses
BOLD effect in the maternal liver of IUGR fetuses
Measure a Bold effect in the maternal liver of IUGR fetuses
Measure a Bold effect in the placenta of IUGR fetuses
Feasibility : number of possible perfusion measure
Feasibility : percent of possible perfusion measure
Compare the placental perfusion between eutrophic and RCIU fetuses

Full Information

First Posted
September 9, 2014
Last Updated
April 2, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT02238301
Brief Title
Evaluation of Fetoplacental Oxygenation With Functional MRI in Pregnant Women
Acronym
BOLD-FP
Official Title
Study of the Fetoplacental BOLD Effect in Pregnant Women Using Functional MRI
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2015 (Actual)
Primary Completion Date
September 26, 2019 (Actual)
Study Completion Date
September 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Intrauterine growth restriction (IUGR) is associated with important maternal and perinatal morbidity and mortality. IUGR is typically secondary to defective oxygenation, leading to placental insufficiency. Measurements made in the umbilical cord after puncture fetal blood showed that compared to normal fetuses, fetuses with IUGR are often hypoxic, hypercapnic and acidotic. Pathological placental and fetal oxygenation is considered as a main element of IUGR. To this day, there is no non-invasive exploration method of this oxygenation. The only ways to monitor IUGR are "indirect" ultrasonic analysis of fetal growth and uteroplacental Doppler spectra. Functional BOLD (Blood Oxygen Level dependent) MRI, already used to investigate cerebral, tumor, cardiac oxygenation, highlights local variations of oxygenation. The purpose of this study is to obtain non invasive data of fetoplacental oxygenation through functional BOLD MRI. Comparing data on eutrophic fetuses and IUGR fetuses will determine the potential contribution of this technique in the diagnosis, treatment and medical management of dysfunctional placentas associated with an increased risk of IUGR. a fetal MRI in the pediatric radiology department of Necker-Enfants Malades Hospital or Robert Debré Hospital, for fetal or placental indications as part of usual workup, will be invited to participate in this protocol. At the waning of the scheduled fetal MRI, patients will subsequently receive an additional BOLD and ASL sequence before and after maternal hyperoxygenation. Patients will be included in three centers : Necker Hospital, Robert Debré Hospital and Louis Mourier Hospital. Only at Necker Hospital: a subgroup of patients will be included at the beginning of the protocol for the adjustment of the settings of the MRI machine, for the determination of BOLD sequences' parameters, as well as the selection of the most adapted type of oxygenation mask. In the three centers, investigators will include patients with IUGR fetuses and patients with a eutrophic fetus. A total of two visits (selection visit and baseline) are scheduled for all patients in this trial. Patient selection will be done during a ultrasound visit. Patients can give their consent on the same day or on the MRI appointment day; in all cases the consent will be signed on the day of the appointment MRI. The flow and duration of the oxygenation of the initial group "test patients" will be determined before completion of the examination; for other patients, the flow rate will be determined based on the results of this first group. The duration of the BOLD sequence will be around 10 minutes. The sequences will focus on the feto-placental unit. A first BOLD sequence will be launched under ambient air. The second BOLD sequence will be repeated after 5 minutes of maternal hyperoxygenation. MRI data will be saved and analyzed at the Laboratory of Imaging Research of the team 2 of Paris Cardiovascular Research Center (INSERM U970). The data necessary for the statistical analysis of the study are collected from the medical file of patients included in the study. Data entry will be performed by a research technician on electronic media via an internet browser. The inclusion period will be of 57 months. Each woman's duration of participation will be 1 hour. The maximum duration of the study will be 57 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Growth Restriction
Keywords
Intrauterine growth restriction, BOLD effect

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients "test" (pregnant women with a eutrophic fetus)
Arm Type
Other
Arm Description
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)
Arm Title
Pregnant women with a diagnosis of IUGR fetuses
Arm Type
Active Comparator
Arm Description
Measure of the BOLD effect in the feto-placental units of IUGR fetuses
Arm Title
Pregnant women with eutrophic fetuses
Arm Type
Active Comparator
Arm Description
Measure of BOLD effects of fetal-placental unit eutrophic fetuses
Intervention Type
Other
Intervention Name(s)
Bold sequence patients test
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Bold + ASL sequence
Intervention Description
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 Measure Information:
Title
Highlight a placental BOLD effect
Description
Measured as the difference between the T2* of the placenta under the ambient air and under hyperoxygenation.
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Number of patients with positive difference of signal intensity of maternal liver, under the ambient air and under hyperoxygenation
Time Frame
at inclusion
Title
BOLD effect in the fetal liver and brain of eutrophic fetuses
Description
Measure the BOLD effect in the fetal liver and brain of eutrophic fetuses
Time Frame
at inclusion
Title
BOLD effect in the fetal liver and brain of IUGR fetuses
Description
Measure the BOLD effect in the fetal liver and brain of IUGR fetuses
Time Frame
at inclusion
Title
BOLD effect in the maternal liver of IUGR fetuses
Description
Measure a Bold effect in the maternal liver of IUGR fetuses
Time Frame
at inclusion
Title
Measure a Bold effect in the placenta of IUGR fetuses
Time Frame
at inclusion
Title
Feasibility : number of possible perfusion measure
Time Frame
at inclusion
Title
Feasibility : percent of possible perfusion measure
Time Frame
at inclusion
Title
Compare the placental perfusion between eutrophic and RCIU fetuses
Time Frame
at inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent SALOMON, MD, PhD
Organizational Affiliation
Hospital Necker - Enfants Malades - Public Hospitals of Paris
Official's Role
Study Director
Facility Information:
Facility Name
Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Fetoplacental Oxygenation With Functional MRI in Pregnant Women

We'll reach out to this number within 24 hrs