Predicting Placental Pathologies by Ultrasound Imaging of the Human Placenta During Gestation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With Uterine Artery Indices Completed
研究概览
简要总结
Intrauterine growth restriction (IUGR) is caused when the placenta cannot provide enough nutrients to allow normal growth of the fetus during pregnancy. It is unclear why IUGR happens, but an increase in inflammatory T cells in the placenta known as villitis of unknown etiology (VUE) is observed in many IUGR infants. The investigators aim to develop ultrasound methods for diagnosing VUE to understand it's role in IUGR.
详细描述
Intrauterine growth restriction (IUGR) occurs in 3-10% of all pregnancies and is associated with significant morbidity and mortality during pregnancy, after birth and throughout the child's lifespan. IUGR is caused by the inability of the placental vasculature to provide enough oxygen and nutrients to support the fetus; yet, the mechanisms leading to disruption of placental vasculature are unknown. The placenta of ~50% of IUGR fetuses are infiltrated with inflammatory cells, specifically maternal T cells, which destroy placental blood vessels that support the fetus. This infiltration of T cells is known as villitis of unknown etiology (VUE). The diagnosis of VUE is problematic because it occurs without clinical signs and symptoms of maternal (or fetal) distress and puts the fetus at significant risk of demise. Additionally, VUE commonly recurs in subsequent pregnancies putting future offspring at risk. Yet, the exact prevalence of VUE and its significance in IUGR pathogenesis and outcomes are poorly understood as VUE is only diagnosed after the infant is outside the womb. Therefore, the study aims to recognize risk factors and cellular mechanisms associated with VUE and develop methods for diagnosing and treating VUE in utero, in order to improve infant health.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Known immunodeficiency or pregnancy complication (i.e. preeclampsia or gestational diabetes)
- •Known autoimmune disease (e.g., rheumatoid arthritis or systemic lupus erythematosus) or chronic hypertension
- •Chronic, active viral infections, including HIV-1/2, HTLV-1/2, Hepatitis B or C
- •Solid organ or transplant recipient
- •Current smokers (tobacco exposure within 30 days of registration)
- •Conceptions from assisted reproductive technology (prior Clomid use is allowed)
- •Multiple gestation
- •Ruptured membranes
- •Pregnancy <28 weeks gestation
- •Not planning on delivering at Mayo Clinic
结局指标
主要结局
Number of Participants With Uterine Artery Indices Completed
时间窗: Gestational age of 34-36 weeks
Measured by Doppler and 3D microvessel imaging, used to calculate outcomes 3-5
Number of Patients With Umbilical Artery Indices Completed
时间窗: Gestational Age of 34-36 weeks
Measured by Doppler and 3D microvessel imaging, used to calculate outcomes 3-5
Systolic(S)/Diastolic(D) Ratio
时间窗: Gestational Age of 34-36 weeks
S = Systolic peak (max velocity); Maximum velocity during contraction of the fetal heart. D = End-diastolic flow; Continuing forward flow in the umbilical artery during the relaxation phase of the heartbeat. S/D ratio = (systolic / diastolic ratio)
Resistance Index (RI)
时间窗: Gestational Age of 34-36 weeks
Resistance index (RI) = (systolic velocity - diastolic velocity / systolic velocity)
Pulsatility Index (PI)
时间窗: Gestational age of 34-36 weeks
Pulsatility index (PI) = (systolic velocity - diastolic velocity / mean velocity)
Number of Participants With Placental Pathology Indicating Chronic Villitis
时间窗: Gestational age up to 42 weeks
Using the Amsterdam criteria, following delivery, placentae will be histologically examined for placental villitis (presence of maternal T cells) and graded by severity. High grade involves greater than 10 villi while low grade affects fewer than 10 villi.
次要结局
- Birth Weight of Infant(Gestational age up to 42 weeks)
- Gestational Age at Birth(Gestational age up to 42 weeks)
- Preterm Labor(Gestational age up to 37 weeks)
研究者
Mauro H. Schenone
Principal Investigator
Mayo Clinic