MechanismNCT04833881
Proteomics/Modifier Based on Mass Spectrometry Reveals the Pathogenesis of Eclampsia During Pregnancy and the Screening of Disease Markers
An observational study of Mechanism and Marker Screening, run by Heilongjiang University of Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mechanism, Marker Screening
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2021to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 1. Women with preeclampsia:
- Singleton women who meet the diagnostic criteria for preeclampsia.
- No previous history of major disease.
- Body mass index is between 23-25kg/m2.
- 20-45 years old.
- 22-42 weeks of gestation.
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- Participate in the test voluntarily and sign the informed consent.
- 2. Healthy pregnant women:
- In good health, no history of major diseases before pregnancy, pregnant women and single mothers with healthy fetuses (newborn) after pregnancy and delivery.
- Body mass index is between 23-25kg/m2.
- 20-45 years old.
- 22-42 weeks of gestation.
- Participate in the test voluntarily and sign the informed consent.
Who cannot join
- 1. Women with preeclampsia:
- Patients with essential hypertension.
- Pregnant women with high blood glucose before and/or during pregnancy.
- Convulsions on the basis of preeclampsia that cannot be explained by other reasons.
- 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.
- Twin or multiple births.
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- Pregnant women with mental disorders or mental diseases.
- Using illegal drugs before and after pregnancy.
- Persons with sexually transmitted diseases or infectious diseases.
- Pregnant women receiving prenatal steroid therapy.
- 2. Healthy pregnant women:
- 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.
- 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.
- Women with a clear cause of premature delivery.
- Twin or multiple births.
- Pregnant women with mental disorders or mental diseases.
- Use illegal drugs before and after pregnancy.
- Persons suffering from sexually transmitted diseases or infectious diseases.
- Pregnant women receiving prenatal steroid therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150000
Yuehui Zhang, Dr., 13936415986, chizishui-04@163.com
About this study
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.
- Conditions
- Mechanism, Marker Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| The control group | Not described | |
| Experimental group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2023-08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MechanismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoke Wu, Heilongjiang University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833881
- Sponsor's protocol ID
- PREECLAMPSIA
- Status last verified
- Apr 2021
- First submitted
- 11 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics/Modifier Based on Mass Spectrometry Reveals the Pathogenesis of Eclampsia During Pregnancy and the Screening of Disease Markers
- ClinicalTrials.gov ID
- NCT04833881
- Acronym / sponsor ID
- PREECLAMPSIA
- Conditions
- Mechanism, Marker Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | – | – |
| Experimental group | – | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (13 listed)
- 1. Women with preeclampsia:
Key exclusion criteria (19 listed)
- 1. Women with preeclampsia:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | Experimental group, The control group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanism and Marker Screening, run by Heilongjiang University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuehui Zhang, Dr. (13936415986, chizishui-04@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomics and acetylation modification analysis of placenta, blood, urine, and cervical secretions (time frame: 2023-08). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.