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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnant Women; Registries
• Intervention / Treatment: Other: Pregnant women without intervention

• Study Type: Observational
• Enrollment (Actual): 761194

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women	Other: Pregnant women without intervention; Pregnant women with those exposures of interest determined in specific research based on the registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postpartum hemorrhage	Postpartum bleeding volume ≥500 mL.	Within 24h after delivery
Incidence of preterm birth	Delivery before 37th gestational weeks.	Up to 37 weeks
Incidence of neonatal death	Neonatal death	Within 28 days after delivery
Incidence of pre-eclampsia	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	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	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	Rupture of maternal uterus confirmed by laparotomy.	Up to 42 weeks
Incidence of maternal death	Maternal death	Up to 52 weeks
Incidence of birth defects	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	Neonatal birth weight measured after birth.	Up to 42 weeks
Incidence of stillbirth	Fetus death at or after 20-28 weeks of gestation.	Up to 42 weeks

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: Xiamen Health and Medical Big Data Center, Xiamen Health Commission
• Investigators: Study Director: Xin Sun, PhD, Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): March 1, 2019
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Registry; Longitudinal study; Population-based healthcare database; Pregnant women and offspring
• Other Study ID Numbers: REPRESENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following the policy of Xiamen Health Commission, research institutions could apply for data access by submitting a formal study protocol, subjected to approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center. Ethical review and research registration are mandatory for all studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No