Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607499
Status:
UNKNOWN
Last Update Posted:
2020-10-29
First Post:
2020-10-24
Brief Title:
Pregnancy Registry in West China
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Pregnancy Registry in West China a Hospital-based Database Linking Electronic Medical Records
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 64468 pregnancies of 62690 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 53667 pregnancies about 51964 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 GBT14396-2016 and National Health Standard Criteria for Birth Defects WS 3776-2013
From January 29 2014 to November 29 2019 64468 pregnancies of 62690 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 53667 pregnancies about 51964 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 GBT14396-2016 and National Health Standard Criteria for Birth Defects WS 3776-2013
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None