Study of the Fetoplacental BOLD Effect in Pregnant Women Using Functional MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Highlight a placental BOLD effect
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Bold sequence patients test (Other)
Pregnant women with a diagnosis of IUGR fetuses
Measure of the BOLD effect in the feto-placental units of IUGR fetuses
干预措施: Bold + ASL sequence (Other)
Pregnant women with eutrophic fetuses
Measure of BOLD effects of fetal-placental unit eutrophic fetuses
干预措施: Bold + ASL sequence (Other)
结局指标
主要结局
Highlight a placental BOLD effect
时间窗: at inclusion
Measured as the difference between the T2\* of the placenta under the ambient air and under hyperoxygenation.
次要结局
- 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)
- 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 maternal liver of IUGR fetuses(at inclusion)
- Feasibility : percent of possible perfusion measure(at inclusion)
- Measure a Bold effect in the placenta of IUGR fetuses(at inclusion)
- Feasibility : number of possible perfusion measure(at inclusion)
- Compare the placental perfusion between eutrophic and RCIU fetuses(at inclusion)