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SASH Study - Sonographic Assessment for Severe Hypertension in Pregnancy (SASH)

6 de enero de 2020 actualizado por: TriHealth Inc.
• Adjunctive use of easily-obtainable maternal sonographic vascular measurements assessing volume status, cardiac output, and systemic vascular resistance by means of inferior vena cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x heart rate), stroke volume variation, & radial artery resistance index) augments standard vital sign assessment (pulse pressure and systolic / diastolic predominance) in clinical decision-making potentially leading to more appropriate pharmacologic and clinical therapies with faster resolution of severe hypertension among pregnant women and women in the postpartum period.

Descripción general del estudio

Estado

Desconocido

Descripción detallada

  • Minutes count when it comes to treating and preventing serious complications associated with hypertensive emergencies in pregnancy. The rates of maternal morbidity and mortality are on the rise within the United States whereas the rates are falling in the rest of the developed world. Cardiovascular and neurologic injury associated with the severe hypertension witnessed among women with preeclampsia/eclampsia represent two of the leading causes of maternal mortality within the U.S. Optimizing the clinical identification and response to these perinatal complications represents one means of reducing overall maternal mortality.
  • Point-of-care use of ultrasound technology to augment clinical diagnosis and management is gaining traction throughout nearly all fields of medicine. Obstetricians utilize this technology frequently to assess the fetus and maternal-fetal interface, and our ability to expand its use to assess a deeper understanding of maternal physiology is underutilized. Exploration into the ability to apply clinically-proven point-of-care sonographic techniques to augment maternal care and reduce maternal mortality is warranted.
  • The purpose of this study is to gain a deeper understanding of maternal physiologic changes using easily-obtainable sonographic vascular measurements in the setting of hypertensive emergencies and to assess the utility of these adjunctive maternal sonographic measurements in augmenting clinical decision-making.

Tipo de estudio

De observación

Inscripción (Anticipado)

120

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45220
        • Reclutamiento
        • TriHealth - Good Samaritan and Bethesda North Hospitals
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

  • Group 1: All pregnant women (under the care of the Maternal-Fetal Medicine physicians or Faculty Medical Center physicians with MFM involvement) experiencing a hypertensive emergency (sustained systolic blood pressure > 160 mmHg or sustained diastolic blood pressure > 110 mmHg {or both} on at least two consecutive occasions 15 minutes apart). All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).
  • Group 2: All asymptomatic pregnant women who are undergoing routine obstetric ultrasound evaluations at any gestational age who elect to undergo cardiovascular sonographic assessment for research purposes at no cost. All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).

Descripción

Inclusion Criteria:

  • For symptomatic women, those presenting to triage, admitted to Labor & Delivery or any of the above units who are at risk for developing a hypertensive emergency will be identified by the OBGYN resident staff or attending physicians as "at risk" for hypertensive emergency as based on current chronic hypertension, gestational hypertension, or preeclampsia). Women presenting with or developing new onset hypertensive emergency can be offered recruitment as well given that the performance of these sonographic measures will not interfere with initiating antihypertensive therapy.

Exclusion Criteria:

  • Age < 18 years
  • Non-pregnant
  • Without the capacity to provide informed written consent
  • Non-English speaking without the ability to obtain a hospital interpreter
  • Known atrial-ventricular heart block
  • History of heart failure
  • Moderate-to-Severe bronchial asthma
  • Allergy to the medications used as part of regular care treatment of the patient population
  • Lack of intravenous IV access
  • Concurrent use of antihypertensive medications
  • Congenital heart disease in the mother

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Symptomatic patients
All pregnant women (under the care of the Maternal-Fetal Medicine physicians or Faculty Medical Center physicians with MFM involvement) experiencing a hypertensive emergency (sustained systolic blood pressure > 160 mmHg or sustained diastolic blood pressure > 110 mmHg {or both} on at least two consecutive occasions 15 minutes apart). All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).
Maternal sonographic vascular measurements assessing volume status, cardiac output, and systemic vascular resistance by means of inferior vena cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x heart rate), stroke volume variation, & radial artery resistance index) augments standard vital sign assessment (pulse pressure and systolic / diastolic predominance)
Asymptomatic patients
All asymptomatic pregnant women who are undergoing routine obstetric ultrasound evaluations at any gestational age who elect to undergo cardiovascular sonographic assessment for research purposes at no cost. All participants must be over the age of 18 and capable of consenting to the study (conscious, with capacity for medical decision making for themselves).
Maternal sonographic vascular measurements assessing volume status, cardiac output, and systemic vascular resistance by means of inferior vena cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x heart rate), stroke volume variation, & radial artery resistance index) augments standard vital sign assessment (pulse pressure and systolic / diastolic predominance)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Systolic Blood Pressure
Periodo de tiempo: At Enrollment into the Study
Systolic Blood Pressure at Enrollment into the Study
At Enrollment into the Study

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: William Schnettler, MD, TriHealth Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de diciembre de 2018

Finalización primaria (Anticipado)

1 de diciembre de 2020

Finalización del estudio (Anticipado)

1 de diciembre de 2020

Fechas de registro del estudio

Enviado por primera vez

19 de diciembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

19 de diciembre de 2018

Publicado por primera vez (Actual)

20 de diciembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de enero de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

6 de enero de 2020

Última verificación

1 de enero de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 18-027

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Hipertensión en el embarazo

Ensayos clínicos sobre Cardiovascular Sonographic Assessment

3
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