Pregnancy Registry in West China

• ClinicalTrials.gov Identifier: NCT04607499
• Recruitment Status: Active, not recruiting
• First Posted: October 29, 2020
• Last Update Posted: October 29, 2020
• Sponsor: West China Hospital
• Collaborator: West China Second University Hospital, Sichuan University
• Information provided by (Responsible Party): Jing Tan, West China Hospital

Study Description

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).

Condition or disease
Pregnant Women

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 53667 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 10 Months
• Official Title: Pregnancy Registry in West China: a Hospital-based Database Linking Electronic Medical Records
• Actual Study Start Date: January 2014
• Actual Primary Completion Date: November 2019
• Estimated Study Completion Date: December 2022

Groups and Cohorts

Group/Cohort
Pregnant women; Pregnant women without intervention

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 60 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Sponsors and Collaborators

West China Hospital

West China Second University Hospital, Sichuan University

Investigators

• Study Director: Xinghui Liu, MD; West China Second University Hospital, Sichuan University

More Information

• Responsible Party: Jing Tan, Associate professor of Chinese Evidence-based Medicine Center, West China Hospital
• ClinicalTrials.gov Identifier: NCT04607499
• Other Study ID Numbers: PRWC
• First Posted: October 29, 2020
• Last Update Posted: October 29, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Time Frame: The data will be available after study completion.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jing Tan, West China Hospital:

Registry; Pregnant women; West China; Electronic medical records