An observational study in Hypertensive Disorder Complicating Pregnancy, sponsored by First Affiliated Hospital of Harbin Medical University. Not yet recruiting. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by First Affiliated Hospital of Harbin Medical University · Observational
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.
First Affiliated Hospital of Harbin Medical University is the lead sponsor of 74 studies on the registry; 11 are open to participants now.
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Pregnant women who underwent prenatal examination and delivery in the First Affiliated Hospital of Harbin Medical University from July 2024 to July 2027 were divided into control group and HDP group, with 200 cases in each group.
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Exclusion Criteria:
1. singleton pregnancy; 2. Those who meet the relevant diagnostic criteria in Guidelines for the Diagnosis and Treatment of Hypertensive Disorders during Pregnancy (2020).
data of analysis of multi-omics
Peripheral blood and fecal samples were collected from pregnant women in both the control group and HDP group, both prenatally and postnatally. Additionally, placental, umbilical cord, and umbilical cord blood samples were collected after childbirth. 16S rDNA sequencing was employed to identify differentially expressed pathogenic strains. Metabolomics analysis was also performed on fecal and plasma samples, in conjunction with clinical data analysis, to identify molecular markers that can predict the occurrence of hypertensive disorders of pregnancy.
Time frame: Periprocedural
No study locations are listed for this record.
Start is estimated for May 2025; primary completion for May 2028, 36 months later.
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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Harbin Medical University