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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Océane KACIMI
- Telefonní číslo: +33140275508
- E-mail: oceane.kacimi@aphp.fr
Studijní záloha kontaktů
- Jméno: Rosa-Maria Pr BRUNO
- Telefonní číslo: +33156093991
- E-mail: rosamaria.bruno@aphp.fr
Studijní místa
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Clamart
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Clamart, Clamart, Francie, 92141
- Hôpital Antoine Béclère
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Kontakt:
- Alexandra BENACHI
- Telefonní číslo: +33145374476
- E-mail: alexandra.benachi@aphp.fr
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Vrchní vyšetřovatel:
- Alexandra BENACHI
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Paris
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Paris, Paris, Francie, 75014
- Hôpital Paris Saint Joseph
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Vrchní vyšetřovatel:
- Elie AZRIA
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Kontakt:
- Elie AZRIA
- Telefonní číslo: +33144127570
- E-mail: eazria@hpsj.fr
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Paris, Paris, Francie, 75014
- Hôpital Cochin - Port Royal
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Vrchní vyšetřovatel:
- Vassilis TSATSARIS
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Kontakt:
- Vassilis TSATSARIS
- Telefonní číslo: +33158413871
- E-mail: vassilis.tsatsaris@cch.aphp.fr
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Paris, Paris, Francie, 75015
- Hôpital européen Georges-Pompidou
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Kontakt:
- Rosa-Maria BRUNO
- Telefonní číslo: +33156093991
- E-mail: rosamaria.bruno@aphp.fr
-
Vrchní vyšetřovatel:
- Rosa-Maria BRUNO
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Main objective
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Evaluation of the agreement between PVR measurements obtained by echocardiography and carotid ultrasound as continuous variables.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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.
Časové okno: 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.
Časové okno: 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.
Časové okno: At inclusion visit
|
Mean group score from the post experience usability questionnaire |
At inclusion visit
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- APHP260829
- 2026-A01568-43 (Jiný identifikátor: ANSM)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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
Časový rámec sdílení IPD
Two years after the last publication
Kritéria přístupu pro sdílení 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).
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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