Xiamen Registry of Pregnant Women and Offspring (REPRESENT)

Overview

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.

Full Title of Study: “Xiamen Registry of Pregnant Women and Offspring (REPRESENT): A Population-based, Long-term Follow-up Database Linking Four Major Healthcare Data Platforms”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2019

Interventions

  • Other: Pregnant women without intervention
    • Pregnant women with those exposures of interest determined in specific research based on the registry

Arms, Groups and Cohorts

  • Pregnant women

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

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

  • None.

Gender Eligibility: Female

All pregnant women registered at the Maternal and Child Health Management Platform were enrolled.

Minimum Age: 14 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • West China Hospital
  • Collaborator
    • Xiamen Health and Medical Big Data Center, Xiamen Health Commission
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sun Xin, Professor and director of Chinese Evidence-based Medicine Center – West China Hospital
  • Overall Official(s)
    • Xin Sun, PhD, Study Director, Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University

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