Xiamen Registry of Pregnant Women and Offspring (REPRESENT)
Xiamen Registry of Pregnant Women and Offspring (REPRESENT): A Population-based, Long-term Follow-up Database Linking Four Major Healthcare Data Platforms
To improve the health of women and children under the background of Healthy China 2030, the investigators developed REPRESENT by establishing a pregnancy registry in Xiamen, a sub-provincial city of over four million residents in east China, based on the Maternal and Child Health Management Platform, and then linking to three other platforms, i.e. Residents Healthcare Management Platform, Primary Healthcare Management Platform, and Electronic Healthcare Records (EHR) Platform, which had been developed since 2006. The registry documented information and events about pregnant women from registration at their first trimester to postpartum, and includes the childhood follow up records. The registry not only enables longitudinal follow up of pregnant women and their offspring, but also expands the scope of database from pre-pregnancy exposures to long-term outcomes by data linkage.
During the past 11 years (January 2008 to March 2019), the REPRESENT has accumulated data concerning more than 700 thousands pregnancies. The data volume is substantial with over 800 variables being documented, and most variables are designed as structured fields. The disease categories and codes are standardized according to the International Classification of Diseases 10th Revision (ICD-10). The whole process of data access, data extraction, data processing and data analysis was conducted through an internal-only accessible server at Xiamen Health and Medical Big Data Center. All investigators cannot access sensitive information, are required to sign data confidentiality agreement and should obtain approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center.
연구 개요
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.
Exclusion Criteria:
- None.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
임산부
|
Pregnant women with those exposures of interest determined in specific research based on the registry
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
산후 출혈의 발생률
기간: 배송 후 24시간 이내
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산후 출혈량 ≥500mL.
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배송 후 24시간 이내
|
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조산의 부각
기간: 최대 37주
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임신 37주 이전에 분만.
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최대 37주
|
|
신생아 사망 발생률
기간: 배송 후 28일 이내
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신생아 사망
|
배송 후 28일 이내
|
|
Incidence of pre-eclampsia
기간: Up to 42 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.
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Up to 42 weeks
|
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Incidence of eclampsia
기간: Up to 42 weeks
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Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.
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Up to 42 weeks
|
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Incidence of gestational diabetes
기간: Up to 32 weeks
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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).
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Up to 32 weeks
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Incidence of ruptured uterus
기간: Up to 42 weeks
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Rupture of maternal uterus confirmed by laparotomy.
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Up to 42 weeks
|
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Incidence of maternal death
기간: Up to 52 weeks
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Maternal death
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Up to 52 weeks
|
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Incidence of birth defects
기간: Up to 7 years
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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.
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Up to 7 years
|
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Incidence of neonatal birth weight
기간: Up to 42 weeks
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Neonatal birth weight measured after birth.
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Up to 42 weeks
|
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Incidence of stillbirth
기간: Up to 42 weeks
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Fetus death at or after 20-28 weeks of gestation.
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Up to 42 weeks
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Xin Sun, PhD, Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- REPRESENT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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