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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.
Exclusion Criteria:
- None.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Gravid kvinde
|
Pregnant women with those exposures of interest determined in specific research based on the registry
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Forekomst af postpartum blødning
Tidsramme: Inden for 24 timer efter levering
|
Postpartum blødningsvolumen ≥500 ml.
|
Inden for 24 timer efter levering
|
|
Forekomst af for tidlig fødsel
Tidsramme: Op til 37 uger
|
Levering inden 37. svangerskabsuge.
|
Op til 37 uger
|
|
Hyppighed af neonatal død
Tidsramme: Inden for 28 dage efter levering
|
Neonatal død
|
Inden for 28 dage efter levering
|
|
Incidence of pre-eclampsia
Tidsramme: 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.
|
Up to 42 weeks
|
|
Incidence of eclampsia
Tidsramme: Up to 42 weeks
|
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
Tidsramme: 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).
|
Up to 32 weeks
|
|
Incidence of ruptured uterus
Tidsramme: Up to 42 weeks
|
Rupture of maternal uterus confirmed by laparotomy.
|
Up to 42 weeks
|
|
Incidence of maternal death
Tidsramme: Up to 52 weeks
|
Maternal death
|
Up to 52 weeks
|
|
Incidence of birth defects
Tidsramme: 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.
|
Up to 7 years
|
|
Incidence of neonatal birth weight
Tidsramme: Up to 42 weeks
|
Neonatal birth weight measured after birth.
|
Up to 42 weeks
|
|
Incidence of stillbirth
Tidsramme: Up to 42 weeks
|
Fetus death at or after 20-28 weeks of gestation.
|
Up to 42 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Xin Sun, PhD, Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- REPRESENT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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