Xiamen Registry of Pregnant Women and Offspring (REPRESENT)

NCT04222621 | Unknown DMC

• 1 other identifier: REPRESENT
• Study Type: observational
• Target: 761,194
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnant Women; Registries

Keywords

Population-based healthcare database; Registry; Pregnant women and offspring; Longitudinal study

Outcome Measures

Primary Outcomes (11)

• 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 postpartum hemorrhage

  Postpartum bleeding volume ≥500 mL.

  Within 24h after delivery

• 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 preterm birth

  Delivery before 37th gestational weeks.

  Up to 37 weeks

• Incidence of neonatal birth weight

  Neonatal birth weight measured after birth.

  Up to 42 weeks

• Incidence of neonatal death

  Neonatal death

  Within 28 days after delivery

• Incidence of stillbirth

  Fetus death at or after 20-28 weeks of gestation.

  Up to 42 weeks

Study Arms (1)

Pregnant women

Other: Pregnant women without intervention

Interventions

Pregnant women without intervention OTHER

Pregnant women with those exposures of interest determined in specific research based on the registry

Pregnant women

Eligibility Criteria

• Age: 14 Years - 65 Years
• Gender Eligibility Details: All pregnant women registered at the Maternal and Child Health Management Platform were enrolled.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• West China Hospital: lead
• Xiamen Health and Medical Big Data Center, Xiamen Health Commission: collaborator

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Xin Sun, PhD

  Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and director of Chinese Evidence-based Medicine Center

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 10, 2020
• Study Start: January 1, 2008
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2023
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share