Functional Imaging of Human Placenta by MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 2
- 主要终点
- Composite of placenta-mediated adverse pregnancy outcomes
研究概览
简要总结
The purpose of this study is to test the application of newly generated magnetic resonance imaging (MRI) protocols for the assessment of placental perfusion in human subjects. The primary objective is to validate and establish the utility of placental MRI in pregnant women. The study will be entirely MRI-technology based with collection of placental tissue at the time of infant delivery for later correlative studies.
详细描述
The placenta provides all the nutrition from a pregnant mother to a developing fetus. A placenta that functions normally is needed to ensure normal fetal growth and development. Unfortunately, the placenta is the least understood human organ even though it is involved in all pregnancy complications. The placenta is so poorly understood because our current methods to look at it during pregnancy, like ultrasound, do not provide enough information about placental growth and function.
This study will help provide information about:
- How the placenta grows and develops during pregnancy
- How the placenta delivers nutrients, like oxygen to the developing fetus
- If placental function using new advanced imaging tools can predict pregnancy complications like fetal growth restriction, stillbirth, preeclampsia and preterm labor
This study will explore how blood flow to the placenta affects placental growth, fetal growth, and oxygen delivery to the fetus. Blood flow to the placenta may determine how the placenta supports fetal growth and development. Having a way to measure placental function during pregnancy may provide a way to understand normal pregnancies but importantly also identify pregnancies at increased risk for pregnancy complications.
Additionally we want to have an ancillary intrauterine growth restriction (IUGR) arm; the objective of this ancillary study is to test the sensitivity of the placental MRI protocol in women with confirmed cases of IUGR in the third trimester.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Composite of placenta-mediated adverse pregnancy outcomes
时间窗: 39 weeks gestation
A binary variable indication whether the placenta-mediated adverse pregnancy has observed within 39 weeks gestation Composite of placenta-mediated adverse pregnancy outcomes defined as the presence of at least one of the following: 1. Fetal death (not due to genetic or infectious etiology), 2. Preeclampsia or gestational hypertension, 3. Small for gestational age fetus \< 5%, 4. Oligohydramnios (defined as amniotic fluid index (AFI) \< 5 cm) prompting delivery prior to 39 weeks gestation, 5. Abnormal fetal heart rate tracing prompting delivery prior to 39 weeks gestation, 6. Abnormal umbilical artery Doppler velocimetry prompting delivery prior to 39 weeks gestation.
Optimal cutoff values of placental MRI for placenta mediated adverse outcomes using receiver operating characteristics (ROC)
时间窗: Change from 16, 24, and 32 weeks gestation
Determine the sensitivity and specificity of placental MRI at 16, 24, and 32 weeks gestation for identifying risk of adverse clinical outcome identified later in pregnancy. Optimal cutoff values of placental MRI for placenta mediated adverse outcomes using receiver operating characteristics (ROC).
Placental perfusion (Units of measure: ml/min) measured at 3 time points across gestation.
时间窗: Change from 16, 24, and 32 weeks gestation
This will allow perfusion changes across pregnancy to be quantified in women from the three study groups.
次要结局
- Small for gestational age fetus at 3% and 5%(39 weeks gestation)
- Gestational age at delivery prior to 37 weeks gestation.(37 weeks gestation)
- Composite of Placenta histologic outcomes(39 weeks gestation)
- Diagnosis of preeclampsia using standard clinical criteria(39 weeks gestation)
研究者
Antonio E. Frias
Associate Professor
Oregon Health and Science University