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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanism; Marker Screening
• Intervention / Treatment: Other

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Yuehui Zhang, Dr.; Phone Number: 13936415986; Email: chizishui-04@163.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
      • Contact: Yuehui Zhang, Dr.; Phone Number: 13936415986; Email: chizishui-04@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Experimental group
The control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Heilongjiang University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia
• Other Study ID Numbers: Preeclampsia (Other Identifier: Al-Ahliyya Amman University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No