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Labour Analgesia and Movement in Babies (LAMB)

10 de febrero de 2012 actualizado por: University of British Columbia

The Effect of Labour Analgesia on Babies' Movements After Birth: An Actigraphic Study

This study aims to measure movements in babies after they are born using an actigraph, a wristwatch-sized device worn on the ankle, which works similarly to the device used by runners to count the number of steps they have taken. We aim to compare the movements of babies whose mothers have received different types of pain relief in labour.

Descripción general del estudio

Estado

Terminado

Descripción detallada

The purpose of the study is to investigate the potential utility of actigraphy, a non-invasive means of measuring an individual's movements, in distinguishing the effects of different types of maternal labour analgesia on babies after birth.

The study hypothesizes that actigraphic data can be used to differentiate the effects on neonates of different forms of maternal intrapartum analgesia. In particular, we hypothesize that infants of mothers who receive intrapartum opioid analgesia will demonstrate fewer movements than infants of mothers who receive epidural analgesia or those who receive nothing.

Whilst it is well known that drugs administered to mothers during labour can affect their babies, means of assessing this effect are complex and unreliable. A more objective means of assessing babies after birth is required, and actigraphy may represent a useful technique. Actigraphy has been used on babies in other studies in a variety of settings, including comparing babies born by different delivery modes (i.e. vaginal versus cesarean delivery) and at different gestations (i.e. term versus preterm), although none of these studies have considered maternal analgesia received prior to delivery as a possible influence on babies' movements after birth. Other studies that have looked at sleep parameters in babies, particularly measures of activity, have shown association with later indices of psychomotor development.

The objective of the study is to compare actigraph-derived movement data from babies whose mothers have received any of the commonly used analgesic techniques for labour at BC Women's Hospital.

This is a prospective observational study. Women will be assessed for eligibility for the study on admission to the labour ward. As one of the inclusion criteria is vaginal birth, women considered eligible on admission may become ineligible depending on their mode fo delivery. Information will be available to all women in the assessment rooms and consent will be specifically sought after they deliver and are deemed eligible. We plan to recruit the babies of mothers who receive analgesia in one of four categories: no analgesia or nitrous oxide only; systemically administered opioid analgesia only; epidural analgesia with an intermediate total dose of fentanyl (<150mcg); epidural analgesia with a high total dose of fentanyl (>150mcg). We recognize that women may receive several or even all of the different modalities of labour analgesia in the course of their delivery. In this situation, we will calculate the total dose fo opioid received by all routes and convert this to fentanyl equivalents for the purposes of analysis. Neonates of women who agree to participate will be fitted with an actigraph that will remain in place (except for removal for bathing) for 24 hours, or until discharge from hospital. Actigraphs are small, light-weight, wrist-watch-sized monitors that weight 16 grams. The actigraphs will be placed on the neonates' ankle, as this position has been reported to cause less disturbance to them. Parents of participating neonates will also be instructed in the use fo a daily dairy that will allow correlation of actigraphic movement data with events such as bathing (when the actigraph will necessarily be removed) and other external sources of movements (e.g. being rocked, breastfeeding).

Tipo de estudio

De observación

Inscripción (Actual)

40

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.

Ubicaciones de estudio

    • British Columbia
      • Vancouver, British Columbia, Canadá, V6H 3N1
        • British Columbia Women's Hospital

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

19 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra de probabilidad

Población de estudio

Healthy women who have vaginal deliveries at BC Women's Hospital

Descripción

Inclusion Criteria:

  • Neonates born to healthy women with singleton pregnancies who deliver vaginally at term gestation (> 37 weeks)
  • Mothers aged 19 years or older and understand written and oral English
  • Neonates who are neurologically healthy

Exclusion Criteria:

  • Cesarean delivery; patients booked for cesarean delivery presenting in labour
  • Maternal opioid dependence
  • Maternal sedative or psychotropic medications
  • Maternal combined spinal epidural (CSE) analgesia in labour
  • Forceps delivery; 4th degree perineal tears
  • Birth weight greater than 4.5 kg
  • Intrapartum fetal heart rate abnormalities requiring immediate delivery
  • Neonates of mothers who receive epidural morphine for post-delivery analgesia
  • Neonates requiring admission to NICU
  • Neonates with obvious congenital anomalies

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
No labour analgesia/nitrous oxide
Women who use no analgesia during labour or who only used nitrous oxide.
Systemic opioids
Women who receive only systemic opioids for analgesia during, either intravenously or intramuscularly
Intermediate dose epidural fentanyl
Women who receive a total epidural fentanyl dose less than 150 micrograms
High dose epidural fentanyl
Women who receive a total epidural fentanyl dose more than 150 micrograms

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Neonates' mobile and immobile time in 24 hours
Periodo de tiempo: Within the first 24 hours of life
Within the first 24 hours of life
Neonates' number of mobile and immobile bouts in 24 hours
Periodo de tiempo: Within the first 24 hours of life
Within the first 24 hours of life
Total activity score
Periodo de tiempo: Within the first 24 hours of life
Within the first 24 hours of life

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Neonates' total sleep time in 24 hours, night-time sleep in 24 hours and day-time sleep in 24 hours
Periodo de tiempo: Within the first 24 hours of life
Within the first 24 hours of life
Neonates' total number of sleep bouts
Periodo de tiempo: Within the first 24 hours of life
Within the first 24 hours of life

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Naomi Kronitz, MD, FRCPC, Department of Anesthesia BC Women's Hospital

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

1 de febrero de 2011

Finalización primaria (Actual)

1 de agosto de 2011

Finalización del estudio (Actual)

1 de agosto de 2011

Fechas de registro del estudio

Enviado por primera vez

18 de enero de 2011

Primero enviado que cumplió con los criterios de control de calidad

19 de enero de 2011

Publicado por primera vez (Estimar)

20 de enero de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de febrero de 2012

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

10 de febrero de 2012

Última verificación

1 de febrero de 2012

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • H10-02900

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. .

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