- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02178878
Genetic and Demographic Factors That Influence the Pain and Progress of Labor
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
There is enormous variability among women in the progress of normal labor. Labor requires complex integrated interplay between the decidua, uterine cervix and myometrium that can take minutes, days or weeks to occur and is incompletely understood. Understanding the biological variables that underlie differences in labor progress has been hampered by the lack of appropriate models that allow sensitive statistical analysis. Identification of genetic and physiognomic factors that impact normal labor progress will allow for individualization of labor management and better use of societal resources.
Structural models of labor progress were first proposed by Friedman in the 1950s at Columbia University. Aspects of Friedman's model, such as the deceleration phase, have been debated since that time but Friedman's model allowed for identification and quantification of the latent and active phase of labor in populations. These concepts have been modified by the World Health Organization as the WHO Partogram, the use of which has resulted in reduced requirement of oxytocin and reduced incidence of cesarean section.
Dr. Flood's group has developed a continuous bi-exponential model of labor progress and sigmoidal model for labor pain that the investigators have statistically and experimentally validated in several independent databases. The investigators model can be used both prospectively in an individual labor and with large cohorts to identify variables that significantly affect the progress of labor.
The investigators have found in a previous work that parturients who carry G at the 27th amino acid beta-2 adrenergic receptors (β2AR) developed labor pain more rapidly that parturients with the common allele [1]. and the investigators also have found that catechol-O-methyltransferase (COMT) rs4633 genotype TT resulted in a slower latent phase rate, and oxytocin receptor rs53576 genotype GG transitioned to active labor earlier [2].
In this new project, the investigators are planning to use bigger data base, to detect further genes associations, and tested some pharmacogenetic variations that could explain the different response to same medications and doses among patients.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- Reclutamiento
- University of Virginia
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Sub-Investigador:
- Abdullah S Terkawi, M.D.
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Contacto:
- Abdullah S Terkawi, MD
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Charlottesville, Virginia, Estados Unidos, 22903
- Aún no reclutando
- University of Virginia
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Contacto:
- Abdullah S Terkawi, M.D.
- Número de teléfono: 434-242-3145
- Correo electrónico: asterkawi@virginia.edu
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Contacto:
- Marcia Birk
- Correo electrónico: meb2w@virginia.edu
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Sub-Investigador:
- Abdullah S Terkawi, M.D.
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Investigador principal:
- Marcel E Durieux, M.D., Ph.D
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Study participants will be women presenting in term labor.
- Patients of all ethnicities will be included.
- All subjects will be greater than or equal to 18 years of age and able to give consent.
Exclusion Criteria:
- Include preexisting pain syndromes or the regular taking of pain medications.
- Preterm birth (< 37 weeks) and preeclampsia.
- Cervical dilatation more than 6 cm
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Progress, Pain
|
Progress, Pain
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Labor progress variability
Periodo de tiempo: We will monitor data from the entire period of labor, which may last from 1-30 hours
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We will monitor data from the entire period of labor, which may last from 1-30 hours
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Respond variability to different induction, augmentation and pain management medication Prostaglandine, Oxytocin, Epidural analgesia
Periodo de tiempo: admission to hospital discharge ( est. 2-3 days)
|
admission to hospital discharge ( est. 2-3 days)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Abdullah S Terkawi, M.D., University of Virginia
- Investigador principal: Marcel E Durieux, M.D., Ph.D, University of Virginia
- Investigador principal: Pamela D Flood, M.D., Ph.D, Stanford University
Publicaciones y enlaces útiles
Publicaciones Generales
- Terkawi AS, Jackson WM, Thiet MP, Hansoti S, Tabassum R, Flood P. Oxytocin and catechol-O-methyltransferase receptor genotype predict the length of the first stage of labor. Am J Obstet Gynecol. 2012 Sep;207(3):184.e1-8. doi: 10.1016/j.ajog.2012.06.079. Epub 2012 Jul 10.
- Terkawi AS, Jackson WM, Hansoti S, Tabassum R, Flood P. Polymorphism in the ADRB2 gene explains a small portion of intersubject variability in pain relative to cervical dilation in the first stage of labor. Anesthesiology. 2014 Jul;121(1):140-8. doi: 10.1097/ALN.0000000000000258.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 17054
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