- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04666285
Southampton Women's Survey COVID-19 Study (SWS_COVID-19)
A Survey of Southampton Women's Survey Women's and Offspring's Health and Wellbeing During the COVID-19 Pandemic and Lockdown.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Between 1998 and 2002 the Southampton Women's Survey (SWS) team interviewed 12,583 Southampton women aged 20 to 34 years. The baseline survey collected data on women's diets, lifestyles, body and blood measures, reproductive health, education, mental health and social circumstances. Of these participants, 3,158 women subsequently became pregnant within the study period and delivered a liveborn singleton infant. The survey has followed up the offspring and mothers with home visits at six months, one, two and three years. A sample of over 1,000 offspring was seen at 4 years of age, more than 2,000 offspring were seen at ages 6-7 years, and more than 1,000 at 8-9 years. Follow-up of offspring aged 11-13 years is being completed and at 17-19 years is being piloted.
The women are currently aged 37 to 57 years and the offspring are currently aged 12 to 21 years.
The COVID-19 pandemic has brought unique challenges across the population. The effects include those of the threat of the virus itself as well as the impact of the government-imposed lockdown on health and wellbeing. Research in many contexts will allow greater understanding of the repercussions of this unprecedented event. The Southampton Women's Survey provides an opportunity to understand the effects of the lockdown on a well-characterised cohort of women and their adolescent/young adult offspring. The longitudinal data available in the cohort will provide a unique opportunity to understand how circumstances earlier in life (including pre-pregnancy) influence people's health and wellbeing during the pandemic.
Objectives:
- To collect individual level data relating to health and wellbeing during the COVID-19 pandemic amongst SWS women and their offspring.
- To assess whether lockdown-specific pressures such as working from home, home schooling and lack of social contact are associated with health and wellbeing during the pandemic.
- To use longitudinal data to understand how health and lifestyle in earlier life (including pre-pregnancy) are associated with health and wellbeing during the pandemic.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Southampton, Reino Unido, SO16 6YD
- MRC Lifecourse Epidemiology Unit
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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:
- Women with offspring born in the Southampton Women's Survey (original project)
- Offspring born in the Southampton Women's Survey (original project)
Exclusion Criteria:
- anyone who was not a part of the original project
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mental Health in women
Periodo de tiempo: 3 months
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General Health Questionnaire (GHQ-12) - higher score more severe condition
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mental Health in offspring
Periodo de tiempo: 3 months
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Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) - higher score describes better mental health
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3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Keith Godfrey, BM, PhD,FRCP, Professor of Human Development and Health
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
Otros números de identificación del estudio
- 56780
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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