Xiamen Registry of Pregnant Women and Offspring (REPRESENT): A Population-based, Long-term Follow-up Database Linking Four Major Healthcare Data Platforms
试验速览
- 阶段
- 不适用
- 入组人数
- 761,194
- 主要终点
- Incidence of stillbirth
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.
排除标准
- 未提供
结局指标
主要结局
Incidence of stillbirth
时间窗: Up to 42 weeks
Fetus death at or after 20-28 weeks of gestation.
Incidence of pre-eclampsia
时间窗: 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.
Incidence of ruptured uterus
时间窗: Up to 42 weeks
Rupture of maternal uterus confirmed by laparotomy.
Incidence of maternal death
时间窗: Up to 52 weeks
Maternal death
Incidence of gestational diabetes
时间窗: 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).
Incidence of birth defects
时间窗: 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.
Incidence of preterm birth
时间窗: Up to 37 weeks
Delivery before 37th gestational weeks.
Incidence of eclampsia
时间窗: Up to 42 weeks
Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.
Incidence of postpartum hemorrhage
时间窗: Within 24h after delivery
Postpartum bleeding volume ≥500 mL.
Incidence of neonatal birth weight
时间窗: Up to 42 weeks
Neonatal birth weight measured after birth.
Incidence of neonatal death
时间窗: Within 28 days after delivery
Neonatal death
次要结局
未报告次要终点
研究者
Sun Xin
Professor and director of Chinese Evidence-based Medicine Center
West China Hospital