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| Name | Class |
|---|---|
| West China Second University Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Pregnant women without intervention |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Xinghui Liu, MD | West China Second University Hospital | Study Director |
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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.
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The data will be available after study completion.
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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 |