PlaCEUS: Feasibility Study of Contrast-enhanced Ultrasound to Visualize Maternal Uterine Spiral Arteries Postpartum.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of participants with persisting spiral arteries detected by contrast enhanced ultrasound within 4 hours postpartum.
研究概览
简要总结
During pregnancy, unique blood vessels form within the uterine wall, known as spiral arteries. These vessels originate from the uterine artery, which is the main artery supplying blood to the uterus. Throughout pregnancy, spiral arteries undergo significant changes to increase blood and oxygen flow to the placenta, ensuring the developing baby receives adequate nutrients. When these arteries fail to remodel properly, complications such as pre-eclampsia or fetal growth restriction can occur.
Until now, direct observation and evaluation of spiral arteries during pregnancy has not been feasible. Contrast-enhanced ultrasound may provide a breakthrough in this area. In this study, the investigators aim to use this imaging technique to visualize spiral arteries after the placenta has been delivered. If successful, this could allow to assess their structural quality. Additionally, the investigators will employ ultrasound to monitor physiological changes in the uterine artery during late pregnancy (after 37 weeks), during labour, and postpartum.
By conducting these measurements, the investigators hope to develop methods for detecting spiral artery abnormalities earlier in pregnancy. Early identification could enable timely interventions and help prevent severe complications.
详细描述
Adequate blood flow to the placenta is critical for normal fetal development and positive pregnancy outcomes. A key component of this process is the maternal uterine spiral arteries, which undergo significant physiological remodeling during pregnancy to meet the growing demands of the fetus. When this remodeling is impaired, it has been linked to complications such as preeclampsia, fetal growth restriction, and placental abruption.
Despite its importance, directly and non-invasively assessing the maternal uterine microvasculature-particularly spiral arteries-remains difficult. Conventional Doppler ultrasound only provides indirect insights by estimating vascular resistance at a macroscopic level and cannot visualize spiral arteries or directly evaluate placental perfusion. Contrast-enhanced ultrasound (CEUS) represents a promising alternative, as it improves visualization of small vessels through the use of ultrasound contrast agents (UCAs). Since UCAs are currently not approved for use during pregnancy, this study focuses on assessing the feasibility of CEUS for visualizing persistent spiral arteries in the immediate postpartum period, as an initial step toward investigating the maternal side of the placenta. In addition, Doppler waveform analysis of the uterine arteries will be performed at three time points: before delivery, during labor, and after birth. Combining CEUS with Doppler imaging may provide a more comprehensive understanding of dynamic uteroplacental vascular changes around delivery.
The primary objectives are to determine whether maternal uterine spiral arteries remain present after delivery and to evaluate the feasibility of CEUS with UCAs in visualizing and characterizing these arteries within four hours postpartum.
Secondary objectives include assessing uterine artery Doppler parameters before, during, and after delivery to describe peripartum hemodynamic changes, and correlating CEUS findings at four hours postpartum with Doppler measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Pregnant patient at a minimum age of 18 years
- •Singleton pregnancy at term (≥37 weeks gestation)
- •Planning to deliver at the Máxima Medical Centre
- •Able to provide informed consent
- •Intravenous access present at the time of delivery
排除标准
- •Multiple gestation pregnancy
- •Contra-indications to CEUS, e.g. known allergy for constituents of SonoVue™
- •Planning on breastfeeding
- •Medical emergency during or after delivery, which makes CEUS impossible or undesirable
- •No intravenous access present at the time of delivery
- •Body Mass Index >40 kg/m
- •Pre-eclampsia requiring medication
- •Foetal growth restriction < p3
研究组 & 干预措施
CEUS
All participants included in the study will receive contrast enhanced ultrasound imaging postpartum. During pregnancy, during labour and postpartum Doppler parameters of the uterine arterie will be performed.
干预措施: SonoVue (sulphur hexafluoride microbubbles) (Diagnostic Test)
结局指标
主要结局
Number of participants with persisting spiral arteries detected by contrast enhanced ultrasound within 4 hours postpartum.
时间窗: Within 4 hours postpartum
Presence of persisting spiral arteries will be assessed using contrast enhanced ultrasound (CEUS) with Sonovue within 4 hours postpartum. The transition of spiral arteries into the intervillous space will be identified at the interface between the decidua and the basal plate of the placenta. Depending on placental location, a sagittal or coronal plane will be selected for optimal visualization. The probe will be positioned perpendicular (90°) to the uteroplacental interface, and color Doppler will be activated to confirm unidirectional flow at the spiral artery opening. Persistence of spiral arteries will be determined as a dichotomous outcome. Visbile or not visible. The number of patients will be calculated in whom the result was: visible.
Feasibility of Contrast Enhanced Ultrasound (CEUS) with Sonovue for visualizing spiral arteries within 4 hours postpartum. Dichotomous outcome; visible or invisible spiral arteries.
时间窗: Within 4 hours postpartum
Feasibility will be assessed by determining whether CEUS with Sonovue successfully visualizes and characterizes maternal uterine spiral arteries within 4 hours postpartum. A scan will be considered feasible if the transition of spiral arteries into the intervillous space can be identified at the uteroplacental interface using the predefined imaging protocol (correct probe orientation, sagittal/coronal plane selection, and confirmation of unidirectional flow with color Doppler). The outcome is dichotomous. The spiral arteries are visible or not visible.
次要结局
- Change in uterine artery Resistance Index (RI) across peripartum period(Before delivery (after 37 weeks of gestation), during delivery (when in active labour or at the same day prior to a Caesarean delivery), and within 4 hours postpartum.)
- Change in uterine artery Pulsatility Index (PI) across peripartum period(Before delivery (after 37 weeks of gestation), during delivery (when in active labour or at the same day prior to a Caesarean delivery), and within 4 hours postpartum.)
- Change in uterine artery Systolic/Diastolic Ratio across peripartum period(Before delivery (after 37 weeks of gestation), during delivery (when in active labour or at the same day prior to a Caesarean delivery), and within 4 hours postpartum.)
- Correlating CEUS findings with uterine artery Doppler parameters within 4 hours postpartum(Within 4 hours postpartum)
研究者
Loes Monen
Dr.
Maxima Medical Center