Intrauterine Growth RestrictionBOLD-FPNCT02238301
Evaluation of Fetoplacental Oxygenation With Functional MRI in Pregnant Women
A study testing Bold sequence patients test and Bold + ASL sequence in people with Intrauterine Growth Restriction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intrauterine Growth Restriction
- What is being tested?
- Bold sequence patients test and Bold + ASL sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2015to 26 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)
Paris, 75015
About this study
Official title: 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.
Read the 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.
- Conditions
- Intrauterine Growth Restriction
- Being tested
- Bold sequence patients test, Bold + ASL sequence
- Keywords
- Intrauterine growth restriction, BOLD effect
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bold sequence patients testOther
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 sequenceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Bold + ASL sequence |
| Pregnant women with eutrophic fetuses | Active comparator | Measure of BOLD effects of fetal-placental unit eutrophic fetuses Receives: Other: Bold + ASL sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highlight a placental BOLD effect
Measured as the difference between the T2* of the placenta under the ambient air and under hyperoxygenation.
Measured: at inclusion
Secondary outcomes (8)
Number of patients with positive difference of signal intensity of maternal liver, under the ambient air and under hyperoxygenation
Measured: 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
Measured: 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
Measured: at inclusion
BOLD effect in the maternal liver of IUGR fetuses
Measure a Bold effect in the maternal liver of IUGR fetuses
Measured: at inclusion
Measure a Bold effect in the placenta of IUGR fetuses
Measured: at inclusion
Feasibility : number of possible perfusion measure
Measured: at inclusion
Feasibility : percent of possible perfusion measure
Measured: at inclusion
Compare the placental perfusion between eutrophic and RCIU fetuses
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study start18 Feb 2015
- Primary completion26 Sep 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Laurent SALOMON, MD, PhD, Study director, Hospital Necker - Enfants Malades - Public Hospitals of Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238301
- Sponsor's protocol ID
- P130924
- Acronym
- BOLD-FP
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2014
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 37743665
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Fetoplacental BOLD Effect in Pregnant Women Using Functional MRI
- ClinicalTrials.gov ID
- NCT02238301
- Acronym / sponsor ID
- BOLD-FP / P130924
- Conditions
- Intrauterine Growth Restriction
- Keywords
- Intrauterine growth restriction, BOLD effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 18 Feb 2015 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients "test" (pregnant women with a eutrophic fetus) | Other | Other: Bold sequence patients testTest 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) |
| Pregnant women with a diagnosis of IUGR fetuses | Active comparator | Other: Bold + ASL sequenceMeasure of the BOLD effect in the feto-placental units of IUGR fetuses |
| Pregnant women with eutrophic fetuses | Active comparator | Other: Bold + ASL sequenceMeasure of BOLD effects of fetal-placental unit eutrophic fetuses |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bold sequence patients testDevelop 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 | Other | Patients "test" (pregnant women with a eutrophic fetus) |
| Bold + ASL sequenceA 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. | Other | Pregnant women with a diagnosis of IUGR fetuses, Pregnant women with eutrophic fetuses |
Primary outcome
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.
8 secondary outcomes
Number of patients with positive difference of signal intensity of maternal liver, under the ambient air and under hyperoxygenation
Time frame: at inclusion
BOLD effect in the fetal liver and brain of eutrophic fetuses
Time frame: at inclusion
BOLD effect in the fetal liver and brain of IUGR fetuses
Time frame: at inclusion
BOLD effect in the maternal liver of IUGR fetuses
Time frame: at inclusion
Measure a Bold effect in the placenta of IUGR fetuses
Time frame: at inclusion
Feasibility : number of possible perfusion measure
Time frame: at inclusion
Feasibility : percent of possible perfusion measure
Time frame: at inclusion
Compare the placental perfusion between eutrophic and RCIU fetuses
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 37743665Jacquier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent SALOMON, MD, PhD study director
Hospital Necker - Enfants Malades - Public Hospitals of Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bold sequence patients test and Bold + ASL sequence in people with Intrauterine Growth Restriction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highlight a placental BOLD effect (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02238301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.