Pregnancy Registry in West China

Pregnant Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04607499
• Other study ID #: PRWC
• Status: Active, not recruiting
• Start date: January 2014
• Est. completion date: December 2022

Study information

• Verified date: October 2020
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53667
• Est. completion date: December 2022
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnant Women

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
West China Hospital	West China Second University Hospital, Sichuan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Incidence of ruptured uterus	Rupture of maternal uterus confirmed by laparotomy.	Up to 40 weeks
Primary	Incidence of postpartum hemorrhage	Postpartum bleeding volume =500 mL.	Within 24h after delivery
Primary	Incidence of maternal death	Maternal death	Up to 40 weeks
Primary	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
Primary	Incidence of preterm birth	Delivery before 37th gestational weeks.	Up to 37 weeks
Primary	Value of neonatal birth weight	Neonatal birth weight measured after birth.	Within 24h after delivery
Primary	Incidence of neonatal death	Neonatal death	Within 28 days after delivery
Primary	Incidence of stillbirth	Fetus death at or after 20-28 weeks of gestation.	Up to 40 weeks