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

5. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Frankreich
    • Clamart
      • Clamart, Clamart, Frankreich, 92141
        • Hôpital Antoine Béclère
        • Kontakt:
        • Hauptermittler:
          • Alexandra BENACHI
    • Paris
      • Paris, Paris, Frankreich, 75014
        • Hôpital Paris Saint Joseph
        • Hauptermittler:
          • Elie AZRIA
        • Kontakt:
      • Paris, Paris, Frankreich, 75014
        • Hôpital Cochin - Port Royal
        • Hauptermittler:
          • Vassilis TSATSARIS
        • Kontakt:
      • Paris, Paris, Frankreich, 75015
        • Hôpital européen Georges-Pompidou
        • Kontakt:
        • Hauptermittler:
          • Rosa-Maria BRUNO

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: 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.
Diagnosetest: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Main objective
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluation of the agreement between PVR measurements obtained by echocardiography and carotid ultrasound as continuous variables.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: At inclusion visit

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Assistance Publique - Hôpitaux de Paris

Mitarbeiter

Ministry of Health, France

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

23. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. November 2026

Zuerst gepostet (Tatsächlich)

12. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • APHP260829
  • 2026-A01568-43 (Andere Kennung: ANSM)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

Two years after the last publication

IPD-Sharing-Zugriffskriterien

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).

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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