Evaluation of Fetoplacental Oxygenation With Functional MRI in Pregnant Women

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT02238301
• Date of registration: 09/09/2014
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Evaluation of Fetoplacental Oxygenation With Functional MRI in Pregnant Women BOLD-FP
• Scientific title: Study of the Fetoplacental BOLD Effect in Pregnant Women Using Functional MRI
• Date of first enrolment: February 18, 2015
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02238301
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Laurent SALOMON, MD, PhD
• Affiliation: Hospital Necker - Enfants Malades - Public Hospitals of Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Intrauterine Growth Restriction

Intervention(s)

Other: Bold + ASL sequence

Other: Bold sequence patients test

Primary Outcome(s)

Highlight a placental BOLD effect [Time Frame: at inclusion]

Secondary Outcome(s)

Feasibility : number of possible perfusion measure [Time Frame: at inclusion]

BOLD effect in the fetal liver and brain of eutrophic fetuses [Time Frame: at inclusion]

Measure a Bold effect in the placenta of IUGR fetuses [Time Frame: at inclusion]

Compare the placental perfusion between eutrophic and RCIU fetuses [Time Frame: at inclusion]

BOLD effect in the fetal liver and brain of IUGR fetuses [Time Frame: at inclusion]

Feasibility : percent of possible perfusion measure [Time Frame: at inclusion]

BOLD effect in the maternal liver of IUGR fetuses [Time Frame: at inclusion]

Number of patients with positive difference of signal intensity of maternal liver, under the ambient air and under hyperoxygenation [Time Frame: at inclusion]

Secondary ID(s)

P130924

Source(s) of Monetary Support

Please refer to primary and secondary sponsors