Evaluation of Fetoplacental Oxygenation With Functional MRI in Pregnant Women

Intrauterine Growth Restriction Clinical Trial

— BOLD-FP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238301
• Other study ID #: P130924
• Status: Completed
• Phase: N/A
• Start date: February 18, 2015
• Est. completion date: September 26, 2019

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 26, 2019
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Intervention

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
• 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.

Locations

Country	Name	City	State
France	Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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 fetal growth restricted pregnancies : multicenter — View Citation

Outcome

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