Evaluation of Fetoplacental Oxygenation With Functional MRI in Pregnant Women

NCT02238301 | Completed

• 1 other identifier: P130924
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Growth Restriction

Keywords

Intrauterine growth restriction; BOLD effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  at inclusion

• BOLD effect in the fetal liver and brain of IUGR fetuses

  at inclusion

• BOLD effect in the maternal liver of IUGR fetuses

  at inclusion

• Measure a Bold effect in the placenta of IUGR fetuses

  at inclusion

Study Arms (3)

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

OTHER

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

Pregnant women with a diagnosis of IUGR fetuses

ACTIVE COMPARATOR

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

Other: Bold + ASL sequence

Pregnant women with eutrophic fetuses

ACTIVE COMPARATOR

Measure of BOLD effects of fetal-placental unit eutrophic fetuses

Other: Bold + ASL sequence

Interventions

Bold sequence patients test OTHER

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

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

Bold + ASL sequence OTHER

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.

Pregnant women with a diagnosis of IUGR fetuses; Pregnant women with eutrophic fetuses

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 37743665 BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent SALOMON, MD, PhD

  Hospital Necker - Enfants Malades - Public Hospitals of Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 12, 2014
• Study Start: February 18, 2015
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

FR (1)