Pregnancy Registry in West China

NCT04607499 | Unknown DMC

• 1 other identifier: PRWC
• Study Type: observational
• Target: 53,667
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pregnant Women

Keywords

Registry; Pregnant women; West China; Electronic medical records

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

Pregnant women

Pregnant women without intervention

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead
• West China Second University Hospital: collaborator

Study Officials

• Xinghui Liu, MD

  West China Second University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Chinese Evidence-based Medicine Center

Study Record Dates

• First Submitted: October 24, 2020
• First Posted: October 29, 2020
• Study Start: January 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2022
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available after study completion.