Xiamen Registry of Pregnant Women and Offspring (REPRESENT)
Xiamen Registry of Pregnant Women and Offspring (REPRESENT): A Population-based, Long-term Follow-up Database Linking Four Major Healthcare Data Platforms
To improve the health of women and children under the background of Healthy China 2030, the investigators developed REPRESENT by establishing a pregnancy registry in Xiamen, a sub-provincial city of over four million residents in east China, based on the Maternal and Child Health Management Platform, and then linking to three other platforms, i.e. Residents Healthcare Management Platform, Primary Healthcare Management Platform, and Electronic Healthcare Records (EHR) Platform, which had been developed since 2006. The registry documented information and events about pregnant women from registration at their first trimester to postpartum, and includes the childhood follow up records. The registry not only enables longitudinal follow up of pregnant women and their offspring, but also expands the scope of database from pre-pregnancy exposures to long-term outcomes by data linkage.
During the past 11 years (January 2008 to March 2019), the REPRESENT has accumulated data concerning more than 700 thousands pregnancies. The data volume is substantial with over 800 variables being documented, and most variables are designed as structured fields. The disease categories and codes are standardized according to the International Classification of Diseases 10th Revision (ICD-10). The whole process of data access, data extraction, data processing and data analysis was conducted through an internal-only accessible server at Xiamen Health and Medical Big Data Center. All investigators cannot access sensitive information, are required to sign data confidentiality agreement and should obtain approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
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:
- Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.
Exclusion Criteria:
- None.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Mujeres embarazadas
|
Pregnant women with those exposures of interest determined in specific research based on the registry
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidencia de hemorragia posparto
Periodo de tiempo: Dentro de las 24h posteriores a la entrega
|
Volumen de sangrado posparto ≥500 ml.
|
Dentro de las 24h posteriores a la entrega
|
|
Incidencia de parto prematuro
Periodo de tiempo: Hasta 37 semanas
|
Parto antes de las 37 semanas de gestación.
|
Hasta 37 semanas
|
|
Incidencia de muerte neonatal
Periodo de tiempo: Dentro de los 28 días posteriores a la entrega
|
Muerte neonatal
|
Dentro de los 28 días posteriores a la entrega
|
|
Incidence of pre-eclampsia
Periodo de tiempo: Up to 42 weeks
|
Maternal systolic blood pressure ≥ 140 mmHg and (or) diastolic pressure ≥ 90 mmHg, accompanied by any one of the following: urinary protein ≥ 0.3g/24 h, or the ratio of urinary protein and creatinine ≥ 0.3, or random urine protein ≥ (+) if quantitative urine protein is not available; no proteinuria but with any damages of heart, lung, liver, kidney and other important organs, or with abnormal changes of blood system, digestive system and nervous system, or placenta fetus involvement, etc.
|
Up to 42 weeks
|
|
Incidence of eclampsia
Periodo de tiempo: Up to 42 weeks
|
Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.
|
Up to 42 weeks
|
|
Incidence of gestational diabetes
Periodo de tiempo: Up to 32 weeks
|
By oral glucose tolerance test between 24 and 28 gestational weeks (fasting glucose ≥5.1 mmol/L, 1-h glucose ≥10.0 mmol/L, 2-h glucose ≥8.5 mmol/L; one abnormal result sufficient).
|
Up to 32 weeks
|
|
Incidence of ruptured uterus
Periodo de tiempo: Up to 42 weeks
|
Rupture of maternal uterus confirmed by laparotomy.
|
Up to 42 weeks
|
|
Incidence of maternal death
Periodo de tiempo: Up to 52 weeks
|
Maternal death
|
Up to 52 weeks
|
|
Incidence of birth defects
Periodo de tiempo: Up to 7 years
|
Birth defects such as anencephaly, spina bifida, encephalocele, hydrocephalus, cleft palate, cleft lip, microtia, esophageal atresia or stenosis, anorectal, hypospadias, ectropion of bladder, talipes equinovarus, polydactylism, ankylodactylia, congenital diaphragmatic hernia, umbilical cord prolapse, gastroschisis, conjoined twins, down syndrome, congenital heart disease, or other birth defects.
|
Up to 7 years
|
|
Incidence of neonatal birth weight
Periodo de tiempo: Up to 42 weeks
|
Neonatal birth weight measured after birth.
|
Up to 42 weeks
|
|
Incidence of stillbirth
Periodo de tiempo: Up to 42 weeks
|
Fetus death at or after 20-28 weeks of gestation.
|
Up to 42 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Xin Sun, PhD, Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
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 (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
Palabras clave
Otros números de identificación del estudio
- REPRESENT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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