Pregnancy Registry in West China

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

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).

Study Overview

• Status: Unknown
• Conditions: Pregnant Women

• Study Type: Observational
• Enrollment (Anticipated): 53667

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnant women; Pregnant women without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pre-eclampsia	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.	22 weeks
Incidence of eclampsia	Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.	22 weeks
Incidence of gestational diabetes	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).	20 weeks
Incidence of ruptured uterus	Rupture of maternal uterus confirmed by laparotomy.	Up to 40 weeks
Incidence of postpartum hemorrhage	Postpartum bleeding volume ≥500 mL.	Within 24h after delivery
Incidence of maternal death	Maternal death	Up to 40 weeks
Incidence of birth defects	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 40 weeks
Incidence of preterm birth	Delivery before 37th gestational weeks.	Up to 37 weeks
Value of neonatal birth weight	Neonatal birth weight measured after birth.	Within 24h after delivery
Incidence of neonatal death	Neonatal death	Within 28 days after delivery
Incidence of stillbirth	Fetus death at or after 20-28 weeks of gestation.	Up to 40 weeks

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: West China Second University Hospital, Sichuan University
• Investigators: Study Director: Xinghui Liu, MD, West China Second University Hospital, Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): November 1, 2019
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 24, 2020
• First Submitted That Met QC Criteria: October 24, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 24, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Registry; Pregnant women; Electronic medical records; West China
• Other Study ID Numbers: PRWC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Research institutions could apply for data access by submitting a formal study protocol, subjected to approval by the West China Second University Hospital of Sichuan University and the Chinese Evidence-based Medicine Center of West China Hospital. Ethical review and research registration are mandatory for all studies.
• IPD Sharing Time Frame: The data will be available after study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No