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NCT06995456Not yet recruiting

Multivariate Analysis and Prediction of Hypertensive Disorder Complicating Pregnancy and Its Related Mechanism

Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Hypertensive disorder complicating pregnancy (HDP) is a unique disease during pregnancy, accounting for about 5.2% \~ 8.2% of pregnant women in the world, which seriously threatens the health and life safety of mothers and infants, and is also one of the important causes of maternal and perinatal deaths. At present, the pathogenesis of HDP is not completely clear, and there is a lack of early effective early warning molecules and limited treatment methods. It is of great significance to find biomarkers that can predict the occurrence of HDP in early pregnancy and explore the pathogenesis of HDP in depth. Intestinal flora is a complex and huge microbial community existing in the digestive tract, which has the function of independent metabolism and plays a vital role in maintaining the dynamic balance of the body and promoting the occurrence and development of diseases. It is found that the intestinal flora and metabolites of pregnant women with HDP have changed significantly, and they are related to blood pressure and proteinuria. Supplementing intestinal microbial decomposition products (such as butyrate, propionate, etc.) in HDP rats can improve intestinal barrier function, inhibit inflammatory reaction, and then lower blood pressure. Therefore, the imbalance of intestinal flora and its metabolites can lead to intestinal barrier damage and activate inflammatory reaction, which may be an important cause of HDP. The investigators selected the patients who underwent prenatal examination and delivery in the First Affiliated Hospital of Harbin Medical University from July 2024 to July 2027, and divided them into control group and hypertensive disorder complicating pregnancy group, with 200 cases in each group. Samples of peripheral blood, feces, placenta, umbilical cord and umbilical cord blood of pregnant women with different gestational weeks were collected, and 16S r DNA sequencing was used to find out the differentially expressed pathogenic strains. At the same time, the metabonomics of feces and plasma samples were detected, combined with clinical data analysis, to find out the molecular markers that can predict the occurrence of hypertensive disorder complicating pregnancy, and to find out the potential preventive measures and therapeutic targets.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
8 May 2025
Start date
25 May 2025
Primary completion date
25 May 2028
Lead sponsor
First Affiliated Hospital of Harbin Medical University
NCT number
NCT06995456

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 25 May 2025 to the primary completion date, 25 May 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with severe cardiovascular diseases, blood system diseases and organ damage before pregnancy;
  • Persons with severe mental illness;
  • Patients with chronic hypertension complicated with pregnancy;
  • History of taking antibiotics, immunotoxic drugs, hormone antagonists and large doses of probiotics within 3 months;

Other

  • Pregnant women who gave birth to children with birth defects in pregnancy outcome;
  • Patients who are not suitable for taking blood samples, such as anemia;
  • Patients who are in an emergency during operation and are difficult to take tissue samples;
  • Patients who refused to participate in the trial.

Who the study is looking for

  • singleton pregnancy;
  • Those who meet the relevant diagnostic criteria in Guidelines for the Diagnosis and Treatment of Hypertensive Disorders during Pregnancy (2020).

Age in the registry: 20 years to 45 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.