Clinical trial NCT04607499: Pregnancy Registry in West China
Official title: Pregnancy Registry in West China: a Hospital-based Database Linking Electronic Medical Records
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnant Women
Keywords: Registry
Pregnant women
West China
Electronic medical records
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: West China Second University Hospital
First posted: 2020-10-29
Enrollment: 53667
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who registered prenatal information during first trimester at the West China Second University Hospital of Sichuan University, and had been followed up till the occurrence of at least one outcome, including any pregnancy complication, abortion, stillbirth, induced labor, and live birth.

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, 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).


Eligibility criteria: Inclusion Criteria:

* Pregnant women who registered prenatal information during first trimester at target hospital, and had been followed up till the occurrence of at least one outcome, including any pregnancy complication, abortion, stillbirth, induced labor, and live birth.

Exclusion Criteria:

* They only registered in the hospital, but lost to follow-up for various reasons, such as transferring out for treatment or delivery; or they were hospitalized for termination of pregnancy (e.g. induced labor) or treatment of any complications (e.g. pregnancy-induced hypertension syndrome), but had no pregnancy registry records at the first trimester; or they registered pre-pregnancy information in the hospital just before the end of the study, none of pregnancy outcomes such as live-birth delivery, has been followed-up within the study period.

Primary outcomes:
measure: Incidence of pre-eclampsia
timeFrame: 22 weeks
measure: Incidence of eclampsia
timeFrame: 22 weeks
measure: Incidence of gestational diabetes
timeFrame: 20 weeks
measure: Incidence of ruptured uterus
timeFrame: Up to 40 weeks
measure: Incidence of postpartum hemorrhage
timeFrame: Within 24h after delivery
measure: Incidence of maternal death
timeFrame: Up to 40 weeks
measure: Incidence of birth defects
timeFrame: Up to 40 weeks
measure: Incidence of preterm birth
timeFrame: Up to 37 weeks
measure: Value of neonatal birth weight
timeFrame: Within 24h after delivery
measure: Incidence of neonatal death
timeFrame: Within 28 days after delivery
measure: Incidence of stillbirth
timeFrame: Up to 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: West China Second University Hospital
name: Xinghui Liu, MD
role: STUDY_DIRECTOR
References: