Delayed Umbilical Cord Clamping - C-section Pilot
Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Despite expert recommendations to delay clamping the cord for at least 2 minutes, early cord clamping remains a common obstetrical practice. The World Health Organization has noted that data on cesarean deliveries are more limited, particularly with respect to long-term effects in infants. Recently, the American College of Obstetrics and Gynecology also noted in a committee statement that " the ideal time for clamping of the umbilical cord in cesarean section vs. vaginal birth is a particularly important area for future research".
The objective of this study is to conduct a pilot trial of delayed cord clamping during cesarean deliveries to determine if progressively longer intervals of cord clamping are feasible and not related to poorer maternal and neonatal outcomes as compared to outcomes from historical controls. We will offer study entry for women planning elective cesarean delivery to collect prospective data on progressively longer intervals, analyzing outcomes for each time interval to ensure they are clinically acceptable, prior to extending the interval another 30 s. We anticipate approximately 20 women at each interval (90 and 120 sec) and will perform hemoglobin analysis on the infants specifically for this study. If intraoperative blood loss is clinically deemed excessive, or mother or baby are unstable, the cord will be clamped.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Medical Center
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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:Subjects that are pregnant (women 18 years of age and older) and scheduled for an elective C-section at ≥ 37 weeks gestation will be eligible for the study.
Exclusion Criteria:
Pregnant women that do not plan on having a C-section and individuals that are not pregnant. Pregnant women that are medically unstable, have poorly controlled diabetes mellitus, multiple gestations, anomalous fetuses and/or severe intrauterine growth retardation will be excluded. Adults unable to consent will not be included
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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90 seconds DCC
the initial 15-20 subjects (15 enrolled subjects who complete study) will have cord clamped at 90 seconds.
Then data will be analyzed and evaluated by DSMB
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Two minutes DCC
If Data Safety Monitoring Board (DSMB) concurs, DCC will then be practiced for 2 minutes for second group, which is the minimum amount of time recommended to be defined as DCC.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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maternal estimated blood loss (EBL)
Periodo de tiempo: at delivery (approximately 1 hour duration)
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Excessive EBL will be assessed by three measures
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at delivery (approximately 1 hour duration)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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neonatal hypothermia
Periodo de tiempo: at admission (within 30 minutes of birth)
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moderate or severe neonatal hypothermia (36.2 rectal or less)
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at admission (within 30 minutes of birth)
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newborn hemoglobin concentration and hematocrit
Periodo de tiempo: first day of life (0-24 h of age)
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mean hemoglobin concentration and incidence of polycythemia (hct >65 with symptoms, 70 without symptoms) and anemia (hgb <14.5 g/dL)
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first day of life (0-24 h of age)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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phototherapy
Periodo de tiempo: < 14 days of age
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phototherapy for hyperbilirubinemia without evidence hemolysis during birth hospitalization or readmission during first 14 d of life
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< 14 days of age
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Neonatal intensive care (NICU) 'observation' or admission
Periodo de tiempo: birth hospitalization (first 72 h of age approximately)
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NICU 'observation' during transition or admission will be measured and reason for admission.
respiratory symptoms are most of interest, but historical controls will only have data yes/no so we will look at overall nicu admissions also.
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birth hospitalization (first 72 h of age approximately)
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Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- 400656-4
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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