Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers
Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preeclampsia With Severe Features and/or Fetal Growth Restriction in Support of a Molecular Assay Development
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Delaware
-
Newark, Delaware, Estados Unidos, 19718
- Christiana Hospital
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02111
- Tufts Medical Center
-
-
New Jersey
-
New Brunswick, New Jersey, Estados Unidos, 08901
- Saint Peter's University Hospital
-
Piscataway, New Jersey, Estados Unidos, 08854
- Rutgers University
-
Sewell, New Jersey, Estados Unidos, 08080
- Virtua Materna-Fetal Medicine Specialists
-
-
New York
-
Flushing, New York, Estados Unidos, 11355
- New York-Presbyterian/Queens
-
New York, New York, Estados Unidos, 10032
- New York-Presbyterian/Columbia University Medical Center
-
New York, New York, Estados Unidos, 11501
- Winthrop University Hospital Clinical Trials Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19102
- Drexel Medicine
-
-
Texas
-
Galveston, Texas, Estados Unidos, 77555
- The University of Texas Medical Branch
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Affected Group: Pregnant women diagnosed with preeclampsia with severe features or fetal growth restriction
Control group: Pregnant women matched for gestational age to the Affected group above
Descripción
Inclusion Criteria:
- Women 18 years of age or older at enrollment
- Pregnant women with a viable singleton gestation
- Able to provide written, informed consent
- Able to provide 20 mL of whole blood
Diagnosis of preeclampsia with severe features and/or diagnosis of fetal growth restriction.
Preeclampsia with severe features is defined as:
Proteinuria: Excretion of ≥300mg/24hr (24 hour collection) of protein or a timed excretion that is extrapolated to the 24 hour urine value or a protein/creatinine [both in mg/dL] ratio of at least 0.3 or a qualitative determination of (urine dipstick) of ≥1+ WITH Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on at least 2 occasions 4 hours apart while on bedrest but before the onset of labor OR Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on 1 occasion but before the onset of labor, if antihypertensive therapy is initiated due to severe hypertension OR New onset hypertension defined as: Systolic BP ≥140 mmHg or diastolic ≥90 mmHg with one or more of the following features: Thrombocytopenia (<100,000 plts/mL); impaired liver function (AST/ALT 2X ULN); newly developed renal insufficiency (serum creatinine >1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease); pulmonary edema; new onset cerebral disturbances or scotomata
- Fetal Growth Restriction defined as:
Estimated fetal weight by ultrasound at ≥ 19 0/7 weeks gestational age < 5%ile or 5-10%ile with abnormal umbilical artery Doppler examination (S/D ratio >95%ile for gestational age, absent end diastolic flow or reverse end diastolic flow)
- Gestational age between 20 0/7 and 33 6/7 weeks determined by ultrasound and/or LMP per ACOG guidelines1. A subject diagnosed with preeclampsia without severe features prior to 33 6/7 weeks gestation and who is managed expectantly and develops severe features after 34 weeks may be included.
Exclusion Criteria:
- Known malignancy
- History of maternal organ or bone marrow transplant
- Maternal blood transfusion in the last 8 weeks
- Chronic hypertension diagnosed prior to current pregnancy
- Type I, II or gestational diabetes
- Fetal anomaly or known chromosome abnormality
- Active labor
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Affected Group
Women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction.
|
|
Control/Unaffected Group
Women who do not have a diagnosis of preeclampsia with severe features and/or fetal growth restriction.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions
Periodo de tiempo: 2 years
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Matthew Rhoa, MD, Illumina, Inc.
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RGH-014
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .