Proteomics/Modifier Based on Mass Spectrometry Reveals the Pathogenesis of Eclampsia During Pregnancy and the Screening of Disease Markers

Mechanism Clinical Trial

Official title:

Proteomics/Modifier Based on Mass Spectrometry Reveals the Pathogenesis of Eclampsia During Pregnancy and the Screening of Disease Markers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833881
• Other study ID #: PREECLAMPSIA
• Status: Recruiting
• Start date: April 2021
• Est. completion date: November 2024

Study information

• Verified date: April 2021
• Source: Heilongjiang University of Chinese Medicine
• Contact: Yuehui Zhang, Dr.
• Phone: 13936415986
• Email: chizishui-04[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pregnancy-induced hypertension is a unique abnormal blood pressure disease in women during pregnancy, including eclampsia, preeclampsia, pregnancy-induced hypertension, chronic hypertension and so on. Eclampsia can lead to convulsions, proteinuria, multiple organ failure, and eventually death. It is a very serious disease in women, and the incidence of pregnancy-induced hypertension during pregnancy is between 4% and 10%. The incidence of eclampsia ranges from 2% to 5%. Studies have shown that there are about 60,000 cases of stillbirth or stillbirth due to eclampsia every year worldwide. At present, there are many theories about the pathogenesis of eclampsia, such as oxidative stress theory, maternal and fetal interaction theory, immune imbalance theory, heredity theory and so on.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• 1. Women with preeclampsia:

1. Singleton women who meet the diagnostic criteria for preeclampsia.

2. No previous history of major disease.

3. Body mass index is between 23-25kg/m2.

4. 20-45 years old.

5. 22-42 weeks of gestation.

6. Participate in the test voluntarily and sign the informed consent.

2. Healthy pregnant women:

1. In good health, no history of major diseases before pregnancy, pregnant women and single mothers with healthy fetuses (newborn) after pregnancy and delivery.

2. Body mass index is between 23-25kg/m2.

3. 20-45 years old.

4. 22-42 weeks of gestation.

5. Participate in the test voluntarily and sign the informed consent.

Exclusion Criteria:

• 1. Women with preeclampsia:

1. Patients with essential hypertension.

2. Pregnant women with high blood glucose before and/or during pregnancy.

3. Convulsions on the basis of preeclampsia that cannot be explained by other reasons.

4. Women with primary disease due to other non-preeclampsia diseases before and after pregnancy, such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic, endocrine, immune, precancerous lesions or cancers, including the reproductive system.

5. Twin or multiple births.

6. Pregnant women with mental disorders or mental diseases.

7. Using illegal drugs before and after pregnancy.

8. Persons with sexually transmitted diseases or infectious diseases.

9. Pregnant women receiving prenatal steroid therapy.

2. Healthy pregnant women:

1. Patients with severe maternal and/or fetal (newborn) adverse events during or after the third trimester of pregnancy or delivery. Such as intrauterine infection, amniotic fluid embolism and other serious maternal adverse events; Fetal malformation, fetal growth restriction, fetal intrauterine distress, neonatal hemolysis and other serious fetal (neonatal) adverse events.

2. Pregnant women with other diseases before and after pregnancy, such as cardiovascular and cerebrovascular, liver, kidney, hematopoietic system, endocrine system, immune system, precancerous lesions or cancer, including the reproductive system, and other serious primary diseases.

3. Women with a clear cause of premature delivery.

4. Twin or multiple births.

5. Pregnant women with mental disorders or mental diseases.

6. Use illegal drugs before and after pregnancy.

7. Persons suffering from sexually transmitted diseases or infectious diseases.

8. Pregnant women receiving prenatal steroid therapy.

Related Conditions & MeSH terms

• Eclampsia
• Marker Screening
• Mechanism

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomics and acetylation modification analysis of placenta, blood, urine, and cervical secretions	Proteomics analysis is carried out using the TMT labeling quantitative method, the significantly differentially expressed proteins and modification sites are screened out, and then the proteins with significantly different changes are used as disease signs; Through the GO classification analysis of the protein, the subcellular structure location analysis of the protein is carried out, and the mitochondrial-related protein and skeleton protein are concerned. Through the enrichment of acetylated antibody modified protein-peptide, the changes of modified protein and its regulatory mechanism were analyzed, and the regulatory role of acetylated protein in mitochondrial metabolism and immune response was found. This study uses the Mfuzz clustering method to perform clustering analysis of the expression profile of proteins, the pathogenesis of the disease through protein enrichment analysis, pathway analysis, and interaction analysis are explored.	2023-08