Xiamen Registry of Pregnant Women and Offspring (REPRESENT)

Pregnant Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04222621
• Other study ID #: REPRESENT
• Status: Active, not recruiting
• Start date: January 2008
• Est. completion date: December 2023

Study information

• Verified date: January 2020
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 761194
• Est. completion date: December 2023
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Pregnant Women
• Registries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
West China Hospital	Xiamen Health and Medical Big Data Center, Xiamen Health Commission

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Incidence of ruptured uterus	Rupture of maternal uterus confirmed by laparotomy.	Up to 42 weeks
Primary	Incidence of postpartum hemorrhage	Postpartum bleeding volume =500 mL.	Within 24h after delivery
Primary	Incidence of maternal death	Maternal death	Up to 52 weeks
Primary	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
Primary	Incidence of preterm birth	Delivery before 37th gestational weeks.	Up to 37 weeks
Primary	Incidence of neonatal birth weight	Neonatal birth weight measured after birth.	Up to 42 weeks
Primary	Incidence of neonatal death	Neonatal death	Within 28 days after delivery
Primary	Incidence of stillbirth	Fetus death at or after 20-28 weeks of gestation.	Up to 42 weeks