- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01834599
Could the Cerebral Oximetry be a Good Technology to Measure Placental Oxygenation?
Could the Cerebral Oximetry (NIRS) be a Good Technology to Measure Placental Oxygenation in Pregnant Woman?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
There is general agreement among experts to recommend the use of phenylephrine as first line therapy for the treatment of arterial hypotension induced by spinal anaesthesia during caesarean delivery. In some studies, there are trends toward a lower PaO2 values in the umbilical cord venous blood when the mother receive this vasopressor. These findings may be a result of the vasoconstrictor effect of phenylephrine on utero-placental vessels, and a subsequent increased oxygen extraction by the fetus. The possibility to extract more oxygen would provide a certain "safety margin" in the event of compromised utero-placental blood flow during normal pregnancy. However, this "safety margin" should not be taken for granted in cases where signs of fetal distress are present, and this situation might influence the choice of vasopressors.
It is well establish on a physiological basis that during labour, utero-placental blood flow is lower during the contractions. This lower blood flow could result in a lower saturation value measured by the cerebral oximeter.
Twenty patients in labour will be included in this study. Patients will be recruited in obstetric clinic during pregnancy. Based on the second trimester ultrasound, patients with anterior placenta will be included.
During labour, once a functional epidural is in place, an Invos oximeter will be install. Two sensors will be applied on the abdomen (one above the placenta and the other above the myometrium at a place without placenta). Two sensors will also be applied on the extremities (forearm and leg).Saturation values and timing of the contractions will be recorded for sixty minutes. Half of the recording will be done with an oxygen mask. Vitals signs will also be registered every five minutes.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Quebec
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Montreal, Quebec, Canadá, H1T 2M4
- Maisonneuve Rosemont Hospital
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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:
- healthy pregnant woman (ASA I or II)
- Term gestation ( > 37 weeks)
- Normal pregnancy
- vaginal delivery
- obstetrical epidural in place
- anterior placenta
Exclusion Criteria:
- patient refusal
- Any contraindication to neuraxial anesthesia
- cesarean section
- multiple gestation
- placentation abnormalities
- anormal placental perfusion
- Placental Abruption
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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anterior placenta
Cerebral oximetry device used to obtain: Saturation value of the placenta probe with no oxygen, saturation value of the placenta probe with oxygen, saturation value of the myometrium probe with no oxygen saturation value of the myometrium probe with oxygen saturation value of the forearm probe with no oxygen, saturation value of the forearm probe with oxygen saturation value of the leg probe with no oxygen saturation value of the leg probe with oxygen Timing between the contractions measure by cardiotocography |
tissue saturation measurement in pregnant women
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Difference between Δp and Δm
Periodo de tiempo: 60 minutes
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Δp = Difference between the mean value area under the curve for the placenta and arm = (Ap- Af) Δm= Difference between the mean value area under the curve for the myometrium and arm = (Am- Af)
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60 minutes
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Difference of the area under the curve of saturation with and without oxygen
Periodo de tiempo: 60 minutes
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Ap with Oxygen - Ap without oxygen; Am with oxygen - Am without oxygen
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60 minutes
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christian Loubert, MD, FRCPC, Maisonneuve-Rosemont Hospital
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- LoubertHMR2013/04
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