China Obstetrics Alliance Cohort Study

NCT03038555 | Unknown

• 1 other identifier: 2016YFC1000405
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 5

Brief Summary

Preeclampsia (PE) is one of a common type of hypertensive disorder complicating pregnancy (HDCP). It is a class of clinical syndromes which shows relevant symptoms, hypertension and proteinuria after 20 weeks pregnant as main characteristic, and may accompany with fetal anomaly and systemic multi-system organs damage. Several complications, such as eclamptic seizures, coma, intracranial hemorrhage (ICH), cardiac failure, pneumonedema, hepatic failure, kidney failure, placental abruption and disseminated intravascular coagulation (DIC), may be threat to the life of the mother as well as fetal. Thus, the disease is one of the core issues that cause the maternal and perinatal death. Morbidity of PE is approximately 3% to 5%. Morbidity has significant differences between different populations. According to the data, from 1995 to 2004, HDCP morbidity in four hospitals in Guangzhou was 5.78%, and in the HDCP, mild preeclampsia and severe preeclampsia were accounted for 72.22% and 27.78% respectively. Meanwhile, HDCP morbidity decreased from 9.4% (1984 to 1989) to 5.57% (1989 to 1998). In 1996, the American Congress of Obstetricians and Gynecologists (ACOG) gave new classification of HDCP based on the characteristic of disease symptoms, divide into five groups; gestational hypertension, preeclampsia, eclampsia, chronic hypertension complicated with preeclampsia and chronic hypertension. The pathogenesis of PE remains unclear so far. The frequent sight is that PE caused by multiple reactions by a number of factors affect. Physiologically, mainly altered of PE is increased blood viscosity and systemic vascular spasm which cause hypoxic-ischemic of multiple key organs, such as the placenta, kidney, liver and brain. The research theory includes abnormal trophoblast invasion, immune response abnormal or increase, genetic susceptibility, coagulation disorders or thrombophilia, abnormal angiogenesis, endothelial cell damage, abnormal levels of carbonic oxide, increase of oxygen radical, abnormal metabolism of calcium ion, heterotrophia and so on. However, there are numbers of epidemiologic study have analyzed high risk factor of PE which provides significant medical evidence of prevention, early diagnosis and early treatment for PE, there is only little study focus on susceptibility gene and pathogenic genetic variation. Nowadays, there are numerous clinical phenotype are considered to exist, different phenotype gives different inheritance and epigenetics. Thus, our group will examine the onset of type and characteristics of PE by a retrospective cohort study to discuss if susceptibility gene and pathogenic genetic variation were existing in PE patients, also to find the relativity between clinical phenotype and genotype. Moreover, this study is trying to reach the effect of PE on the patients' health as well as their children. Thus, can predict the health status of PE patients and their children, and so can prevent (avoid or delay) of the patients from late complications and disease in their children.

Conditions

Preeclampsia

Keywords

Medical staff; preeclampsia; cohort study; further effect

Outcome Measures

Primary Outcomes (1)

• track the difference between preeclampsia and normal

  Our main judgement criterion allowing to distinguish patients with preeclampsia from those without disease

  2 years

Study Arms (2)

Disease group (subject to strategy)

Choose subjects that have ever got PE before as the diseases group.

Control group

Pair the same age, gestational weeks, children's gender and healthy subject as a control group in the ratio of 1:1. The control group should exclude subject that have ever got heart or lung diseases, diabetes, chronic nephrosis, immune disease and other hereditary disease.

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Choose subjects that have got PE before as the experimental group. Pair the same age, gestational weeks, children's gender and healthy subject as a control group in the ratio of 1:1. The control group should exclude subject that have ever got heart or lung diseases, diabetes, chronic nephrosis, immune disease and other hereditary disease.

You may qualify if:

• Choose subjects that have got PE before as the experimental group. Pair the same age, gestational weeks, children's gender and healthy subject as a control group in the ratio of 1:1.

You may not qualify if:

• Subject that have ever got heart or lung diseases, diabetes, chronic nephrosis, immune disease and other hereditary disease.

Sponsors & Collaborators

• The Third Affiliated Hospital of Guangzhou Medical University: lead
• Obstetrics & Gynecology Hospital of Fudan University: collaborator
• Tongji Medical College of Huazhong University of Science & Technology: collaborator
• Xinjiang Maternity & Children Health Care Hospital: collaborator
• Shandong Provincial Hospital: collaborator

Study Sites (5)

Guangzhou Institute of Obstetrics & Gynecology

Guangzhou, Guangdong, 510150, China

Location

Tongji Medical College Huazhong University of Science & Technology

Wuhan, Hubei, 430030, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Xinjiang Maternity & Children Health Care Hospital

Ürümqi, Xinjiang, 96595, China

Location

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Store the blood samples (serum, blood and plasma) of both the experimental group and control group and their children. These additional samples were be centrifuged and treated and stored in a collection of biological samples of total serum and plasma and blood at the Biobank of The Third Affiliated Hospital of Guangzhou Medical University at -80 ° C

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guangzhou Institute of Obstetrics & Gynecology

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 31, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2022
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

CN (5)