Carotid Ultrasound-based Assessment of Maternal Hemodynamics to Guide HYpertension Treatment in PREgnancy - Pilot Study (CHYPRE-Pilot)
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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:
- To evaluate the agreement between PVR measurements obtained by echocardiography and carotid ultrasound as continuous variables.
- To evaluate the agreement between cardiac output (CO)measurements obtained by echocardiography and carotid ultrasound as continuous variables.
- To evaluate inter-operator agreement and variability in carotid ultrasound measurement of PVR between an expert operator and a novice operator.
- To evaluate inter-operator agreement and variability in carotid ultrasound measurement of CO between an expert operator and a novice operator.
Exploratory objectives:
- 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).
- To investigate whether the agreement between the PVR obtained by echocardiography and carotid ultrasound is acceptable in both healthy and pathological pregnancies.
- To evaluate the usability of carotid ultrasound in routine maternity setting.
Secondary endpoints:
- 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.
- 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:
- 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.
- Absence of significant bias in the Bland-Altman analysis both in healthy and pathological pregnancies.
- Mean group score from the post experience usability questionnaire.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Océane KACIMI
- Номер телефона: +33140275508
- Электронная почта: oceane.kacimi@aphp.fr
Учебное резервное копирование контактов
- Имя: Rosa-Maria Pr BRUNO
- Номер телефона: +33156093991
- Электронная почта: rosamaria.bruno@aphp.fr
Места учебы
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Clamart
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Clamart, Clamart, Франция, 92141
- Hôpital Antoine Béclère
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Контакт:
- Alexandra BENACHI
- Номер телефона: +33145374476
- Электронная почта: alexandra.benachi@aphp.fr
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Главный следователь:
- Alexandra BENACHI
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Paris
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Paris, Paris, Франция, 75014
- Hôpital Paris Saint Joseph
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Главный следователь:
- Elie AZRIA
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Контакт:
- Elie AZRIA
- Номер телефона: +33144127570
- Электронная почта: eazria@hpsj.fr
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Paris, Paris, Франция, 75014
- Hôpital Cochin - Port Royal
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Главный следователь:
- Vassilis TSATSARIS
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Контакт:
- Vassilis TSATSARIS
- Номер телефона: +33158413871
- Электронная почта: vassilis.tsatsaris@cch.aphp.fr
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Paris, Paris, Франция, 75015
- Hôpital européen Georges-Pompidou
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Контакт:
- Rosa-Maria BRUNO
- Номер телефона: +33156093991
- Электронная почта: rosamaria.bruno@aphp.fr
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Главный следователь:
- Rosa-Maria BRUNO
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: 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. |
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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Main objective
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Evaluation of the agreement between PVR measurements obtained by echocardiography and carotid ultrasound as continuous variables.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: At inclusion visit
|
Mean group score from the post experience usability questionnaire |
At inclusion visit
|
Соавторы и исследователи
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- APHP260829
- 2026-A01568-43 (Другой идентификатор: ANSM)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Сроки обмена IPD
Two years after the last publication
Критерии совместного доступа к IPD
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).
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .