Clinical trial NCT04222621: Xiamen Registry of Pregnant Women and Offspring (REPRESENT)
Official title: Xiamen Registry of Pregnant Women and Offspring (REPRESENT): A Population-based, Long-term Follow-up Database Linking Four Major Healthcare Data Platforms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnant Women
Registries
Keywords: Population-based healthcare database
Registry
Pregnant women and offspring
Longitudinal study
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Xiamen Health and Medical Big Data Center, Xiamen Health Commission
First posted: 2020-01-10
Enrollment: 761194
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Incidence of pre-eclampsia
timeFrame: Up to 42 weeks
measure: Incidence of eclampsia
timeFrame: Up to 42 weeks
measure: Incidence of gestational diabetes
timeFrame: Up to 32 weeks
measure: Incidence of ruptured uterus
timeFrame: Up to 42 weeks
measure: Incidence of postpartum hemorrhage
timeFrame: Within 24h after delivery
measure: Incidence of maternal death
timeFrame: Up to 52 weeks
measure: Incidence of birth defects
timeFrame: Up to 7 years
measure: Incidence of preterm birth
timeFrame: Up to 37 weeks
measure: Incidence of neonatal birth weight
timeFrame: Up to 42 weeks
measure: Incidence of neonatal death
timeFrame: Within 28 days after delivery
measure: Incidence of stillbirth
timeFrame: Up to 42 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
name: Xin Sun, PhD
role: STUDY_DIRECTOR
References: