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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.
Exclusion Criteria:
- None.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Schwangere Frau
|
Pregnant women with those exposures of interest determined in specific research based on the registry
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Häufigkeit postpartaler Blutungen
Zeitfenster: Innerhalb von 24 Stunden nach Lieferung
|
Blutungsvolumen nach der Geburt ≥500 ml.
|
Innerhalb von 24 Stunden nach Lieferung
|
|
Häufigkeit von Frühgeburten
Zeitfenster: Bis zu 37 Wochen
|
Entbindung vor der 37. Schwangerschaftswoche.
|
Bis zu 37 Wochen
|
|
Häufigkeit von Todesfällen bei Neugeborenen
Zeitfenster: Innerhalb von 28 Tagen nach Lieferung
|
Tod eines Neugeborenen
|
Innerhalb von 28 Tagen nach Lieferung
|
|
Incidence of pre-eclampsia
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 42 weeks
|
Rupture of maternal uterus confirmed by laparotomy.
|
Up to 42 weeks
|
|
Incidence of maternal death
Zeitfenster: Up to 52 weeks
|
Maternal death
|
Up to 52 weeks
|
|
Incidence of birth defects
Zeitfenster: 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
Zeitfenster: Up to 42 weeks
|
Neonatal birth weight measured after birth.
|
Up to 42 weeks
|
|
Incidence of stillbirth
Zeitfenster: Up to 42 weeks
|
Fetus death at or after 20-28 weeks of gestation.
|
Up to 42 weeks
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Xin Sun, PhD, Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- REPRESENT
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .