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Carotid Ultrasound-based Assessment of Maternal Hemodynamics to Guide HYpertension Treatment in PREgnancy - Pilot Study (CHYPRE-Pilot)

2026年11月5日 更新者：Assistance Publique - Hôpitaux de Paris

Carotid ultrasound-based assessment of maternal hemodynamics to guide HYpertension treatment in PREgnancy - Pilot study - CHYPRE-pilot Healthy pregnancy is associated with significant physiological hemodynamic changes that are critical for maternal adaptation and health. Insufficient adaptive changes can lead to pregnancy disorders such as preeclampsia. Hypertensive disorders of pregnancy (HDP) are a leading cause of maternal and foetal morbidity and mortality. Assessment of maternal hemodynamic alterations can improve management strategies by better risk stratification of pregnant women. Current methods for maternal hemodynamic measurement involve transthoracic echocardiography, requiring expert consultation with a cardiologist and highly trained staff. Simpler techniques like carotid ultrasound based hemodynamic assessment can potentially provide an easy-to perform alternative, requiring minimal training.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Aims and objectives of the study Main objective: to evaluate the accuracy of carotid-ultrasound for classifying individuals with very high peripheral vascular resistance (PVR) or not very high PVR during pregnancy, using echocardiography as the standard reference, both performed by an expert operator.

Primary endpoint: The agreement between carotid ultrasound and echocardiography to classify individuals with very high (>1300 dynes.s.cm-5) vs not high (=<1300 dynes.s.cm-5) PVR the day of inclusion. The area under the receiver operating characteristic (AUROC) curve, sensitivity and specificity of carotid ultrasound to identify very high PVR will be calculated.

Secondary objectives:

  1. To evaluate the agreement between PVR measurements obtained by echocardiography and carotid ultrasound as continuous variables.
  2. To evaluate the agreement between cardiac output (CO)measurements obtained by echocardiography and carotid ultrasound as continuous variables.
  3. To evaluate inter-operator agreement and variability in carotid ultrasound measurement of PVR between an expert operator and a novice operator.
  4. To evaluate inter-operator agreement and variability in carotid ultrasound measurement of CO between an expert operator and a novice operator.

Exploratory objectives:

  1. To evaluate the association between very high (>1300 dynes.s.cm-5) PVR during pregnancy (defined using carotid ultrasound) with adverse pregnancy outcomes (preeclampsia or pre-term birth).
  2. To investigate whether the agreement between the PVR obtained by echocardiography and carotid ultrasound is acceptable in both healthy and pathological pregnancies.
  3. To evaluate the usability of carotid ultrasound in routine maternity setting.

Secondary endpoints:

  1. Bland Altman analysis to evaluate the agreement between echocardiography and carotid ultrasound-based estimation of PVR on a continuous scale. Mean differences and bias will be calculated.
  2. Inter-operator variability between expert and novice operator for carotid ultrasound-based PVR measurement using Bland-Altman analysis and Intraclass Correlation Coefficient (ICC) will be performed.

Exploratory endpoints:

  1. Multivariable logistic regression with the PVR group as exposure and adverse pregnancy outcomes (preeclampsia or pre-term birth) as outcome. Adjusted odds for very high PVR vs normal pregnancy will be calculated.
  2. Absence of significant bias in the Bland-Altman analysis both in healthy and pathological pregnancies.
  3. Mean group score from the post experience usability questionnaire.

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 法国
    • Clamart
      • Clamart、Clamart、法国、92141
        • Hôpital Antoine Béclère
        • 接触：
        • 首席研究员：
          • Alexandra BENACHI
    • Paris
      • Paris、Paris、法国、75014
        • Hôpital Paris Saint Joseph
        • 首席研究员：
          • Elie AZRIA
        • 接触：
      • Paris、Paris、法国、75014
        • Hôpital Cochin - Port Royal
        • 首席研究员：
          • Vassilis TSATSARIS
        • 接触：
      • Paris、Paris、法国、75015
        • Hôpital européen Georges-Pompidou
        • 接触：
        • 首席研究员：
          • Rosa-Maria BRUNO

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion criteria:

  • Pregnant women > 18 years of age
  • Singleton pregnancy
  • 10th to 40th week of pregnancy
  • Patients affiliated with social security or an equivalent scheme
  • Signed informed consent

Exclusion criteria:

  • Multifoetal pregnancy
  • Known allergies to ultrasound gel
  • Patient on AME (state medical aid)
  • Patient under a legal protection measure: guardianship, curatorship, or judicial safeguard.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：Pregnant women (>18 years of age) between 10-40th week of pregnancy

We will recruit pregnant women (>18 years of age) between 10-40th week of pregnancy. The study design will be cross-sectional with a total recruitment 200 pregnant women, during routine clinical visits.The element under investigation in this study is the use of carotid ultrasound-derived hemodynamic measurements as a surrogate for CO and PVR assessed by transthoracic echocardiography (TTE) in pregnant women.
诊断测试：Assessment of maternal hemodynamics

Carotid ultrasound and echocardiography will be performed by an expert operator in all participants for comparison with echocardiography. In all participants, a novice operator will also perform carotid ultrasound to assess inter-operator agreement.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Main objective
大体时间：At inclusion visit

To evaluate the accuracy of carotid-ultrasound for classifying individuals with very high peripheral vascular resistance (PVR) or not very high PVR during pregnancy, using echocardiography as the standard reference, both performed by an expert operator.
At inclusion visit

次要结果测量

结果测量
措施说明
大体时间
Evaluation of the agreement between PVR measurements obtained by echocardiography and carotid ultrasound as continuous variables.
大体时间：At inclusion visit

Bland Altman analysis to evaluate the agreement between echocardiography and carotid ultrasound-based estimation of PVR on a continuous scale. Mean differences and bias will be calculated.
At inclusion visit
Evaluation of the agreement between cardiac output (CO)measurements obtained by echocardiography and carotid ultrasound as continuous variables.
大体时间：At inclusion visit

Bland Altman analysis to evaluate the agreement between echocardiography and carotid ultrasound-based estimation of PVR on a continuous scale. Mean differences and bias will be calculated.
At inclusion visit
Evaluation of the inter-operator agreement and variability in carotid ultrasound measurement of PVR between an expert operator and a novice operator.
大体时间：At inclusion visit

Inter-operator variability between expert and novice operator for carotid ultrasound-based PVR measurement using Bland-Altman analysis and Intraclass Correlation Coefficient (ICC) will be performed.
At inclusion visit
Evaluation of the inter-operator agreement and variability in carotid ultrasound measurement of CO between an expert operator and a novice operator.
大体时间：At inclusion visit

Inter-operator variability between expert and novice operator for carotid ultrasound-based PVR measurement using Bland-Altman analysis and Intraclass Correlation Coefficient (ICC) will be performed.
At inclusion visit

其他结果措施

结果测量
措施说明
大体时间
Evaluation of whether pregnant women with very high (>1300 dynes.s.cm-5) PVR during pregnancy (defined using carotid ultrasound) have a higher incidence of adverse pregnancy outcomes (preeclampsia or pre-term birth) compared to pregnant women without.
大体时间：From inclusion visit, up to 7 months maximum (date of delivery)

Single clinically adverse pregnancy outcome defined as incidence of either preeclampsia or pre-term birth - Yes/No Association with PVR tested using multivariable logistic regression.
From inclusion visit, up to 7 months maximum (date of delivery)
Investigation of whether the agreement between the PVR obtained by echocardiography and carotid ultrasound is acceptable in both healthy and pathological pregnancies.
大体时间：At inclusion visit

Absence of significant bias in the Bland-Altman analysis both in healthy and pathological pregnancies.
At inclusion visit
Evaluation of the usability of carotid ultrasound in routine maternity setting.
大体时间：At inclusion visit

Mean group score from the post experience usability questionnaire
At inclusion visit

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assistance Publique - Hôpitaux de Paris

合作者

Ministry of Health, France

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年10月23日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • APHP260829
  • 2026-A01568-43 (其他标识符：ANSM)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD 共享时间框架

Two years after the last publication

IPD 共享访问标准

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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