Xiamen Registry of Pregnant Women and Offspring (REPRESENT)

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Xiamen Registry of Pregnant Women and Offspring (REPRESENT): A Population-based, Long-term Follow-up Database Linking Four Major Healthcare Data Platforms

Conditions
-----------------
Pregnant Women, Registries

Intervention / Treatment
-----------------
* Other: Pregnant women without intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br> | Other: Pregnant women without intervention<br>* Pregnant women with those exposures of interest determined in specific research based on the registry<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | Up to 42 weeks | 
| Incidence of eclampsia | Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders. | Up to 42 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). | Up to 32 weeks | 
| Incidence of ruptured uterus | Rupture of maternal uterus confirmed by laparotomy. | Up to 42 weeks | 
| Incidence of postpartum hemorrhage | Postpartum bleeding volume ≥500 mL. | Within 24h after delivery | 
| Incidence of maternal death | Maternal death | Up to 52 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 7 years | 
| Incidence of preterm birth | Delivery before 37th gestational weeks. | Up to 37 weeks | 
| Incidence of neonatal birth weight | Neonatal birth weight measured after birth. | Up to 42 weeks | 
| 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 42 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Population-based healthcare database, Registry, Pregnant women and offspring, Longitudinal study