NCT04833881

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

3.6 years

First QC Date

March 11, 2021

Last Update Submit

April 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

The control group

Experimental group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • \. 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.
  • years old.
  • weeks of gestation.
  • Participate in the test voluntarily and sign the informed consent.
  • \. 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.
  • years old.
  • weeks of gestation.
  • Participate in the test voluntarily and sign the informed consent.

You may not qualify if:

  • \. 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.
  • 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.
  • \. 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150000, China

RECRUITING

Central Study Contacts

Yuehui Zhang, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director of Obstetrics and Gynecology Department

Study Record Dates

First Submitted

March 11, 2021

First Posted

April 6, 2021

Study Start

April 1, 2021

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

April 6, 2021

Record last verified: 2021-04

Locations