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

Study of the Fetoplacental BOLD Effect in Pregnant Women Using Functional MRI

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.

Study Overview

• Status: Completed
• Conditions: Intrauterine Growth Restriction
• Intervention / Treatment: Other: Bold sequence patients test; Other: Bold + ASL sequence

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highlight a placental BOLD effect	Measured as the difference between the T2* of the placenta under the ambient air and under hyperoxygenation.	at inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Unité de Recherche Clinique Necker Cochin, France
• Investigators: Study Director: Laurent SALOMON, MD, PhD, Hospital Necker - Enfants Malades - Public Hospitals of Paris

Publications and helpful links

General Publications

• Jacquier M, Chalouhi G, Marquant F, Bussieres L, Grevent D, Picone O, Mandelbrot L, Mahallati H, Briand N, Elie C, Siauve N, Salomon LJ. Placental T2* and BOLD effect in response to hyperoxia in normal and growth-restricted pregnancies: multicenter cohort study. Ultrasound Obstet Gynecol. 2024 Apr;63(4):472-480. doi: 10.1002/uog.27496.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2015
• Primary Completion (Actual): September 26, 2019
• Study Completion (Actual): September 26, 2019

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 11, 2014
• First Posted (Estimated): September 12, 2014

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Intrauterine growth restriction; BOLD effect
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Fetal Diseases; Growth Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Fetal Growth Retardation
• Other Study ID Numbers: P130924