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

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ClinicalTrials.gov Identifier: NCT04833881
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine

Study Description
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Brief 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.

Condition or disease
Mechanism Marker Screening

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Proteomics/Modifier Based on Mass Spectrometry Reveals the Pathogenesis of Eclampsia During Pregnancy and the Screening of Disease Markers
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort
The control group
Experimental group


Outcome Measures
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Primary Outcome Measures :
  1. Proteomics and acetylation modification analysis of placenta, blood, urine, and cervical secretions [ Time Frame: 2023-08 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833881


Contacts
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Contact: Yuehui Zhang, Dr. 13936415986 chizishui-04@163.com

Locations
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China, Heilongjiang
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Yuehui Zhang, Dr.    13936415986    chizishui-04@163.com   
Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
More Information
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Responsible Party: Xiaoke Wu, Professor and Director of Obstetrics and Gynecology Department, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT04833881    
Other Study ID Numbers: PREECLAMPSIA
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications