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UnknownNCT04607499

Pregnancy Registry in West China

Pregnancy Registry in West China: a Hospital-based Database Linking Electronic Medical Records

Status
Unknown
Phase
Study type
Observational
Enrollment
53,667 (estimated)
Sponsor
West China Hospital · Academic / Other
Sex
Female
Age
16 Years – 60 Years
Healthy volunteers
Not accepted

Summary

With the Healthy China 2030 Plan for further reducing maternal mortality ratio (MMR), and increasing number of high-risk pregnancies in China, we aimed to develop a registry of pregnant women based on hospital-based Electronic Medical Records (EMR) data in West China, through integrating information technology and medical knowledge, by linking multi-resource data covering information regarding the whole cycle from pregnancy registration till delivery, and process of diagnosis, treatment and pregnancy outcomes, in order to provide reliable, valuable and efficient data resources for researches about high-risk pregnancy safety and MMR reduction in southwestern China. From January 29, 2014 to November 29, 2019, 64,468 pregnancies of 62,690 women were registered around gestational 13th weeks in the hospital, collecting over 47 million records (including repeated measurement data) from Health Information System (HIS), Laboratory Information System (LIS), and Picture Archiving and Communication System (PACS). After excluding 3476 pregnancies lost to follow-up and 7325 newly-pregnancies with expected date of delivery out of the study time, a total of 53,667 pregnancies about 51,964 women were finally included in the registry, who had been followed up till the occurrence of at least one outcome, including any pregnancy complication, abortion, stillbirth, induced labor, and live birth between January 1, 2015 and November 30, 2019. Till now, through data linkage, data collection, cleaning and recoding, we have generated more than 2100 structured variables regarding pre-pregnancy conditions, prenatal visit records, hospitalized diagnosis, treatment and discharge outcomes. The diagnoses of pregnancy complications, maternal and fetal outcomes, recorded by ICD-10 coding or free terms in original fields, were uniformly encoded by the Classification and Codes of Diseases released by Chinese National Standards Institute (GB/T14396-2016) and National Health Standard Criteria for Birth Defects (WS 377.6-2013).

Conditions

Timeline

Start date
2014-01-01
Primary completion
2019-11-01
Completion
2022-12-01
First posted
2020-10-29
Last updated
2020-10-29

Source: ClinicalTrials.gov record NCT04607499. Inclusion in this directory is not an endorsement.

Pregnancy Registry in West China (NCT04607499) · Clinical Trials Directory