Hypertensive Disorder Complicating PregnancyNCT06995456
Multivariate Analysis and Prediction of Hypertensive Disorder Complicating Pregnancy and Its Related Mechanism
An observational study of Hypertensive Disorder Complicating Pregnancy, run by First Affiliated Hospital of Harbin Medical University.
Trial summary
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. 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
- Hypertensive Disorder Complicating Pregnancy
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2025to 25 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- singleton pregnancy;
- Those who meet the relevant diagnostic criteria in Guidelines for the Diagnosis and Treatment of Hypertensive Disorders during Pregnancy (2020).
Who cannot join
- Patients with severe cardiovascular diseases, blood system diseases and organ damage before pregnancy;
- Persons with severe mental illness;
- 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 with chronic hypertension complicated with pregnancy;
- History of taking antibiotics, immunotoxic drugs, hormone antagonists and large doses of probiotics within 3 months;
- Patients who refused to participate in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Keywords
- HDP, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | Not described | |
| HDP group | 1. singleton pregnancy; 2. Those who meet the relevant diagnostic criteria in Guidelines for the Diagnosis and Treatment of Hypertensive Disorders during Pregnancy (2020). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start25 May 2025 (estimated)
- Primary completion25 May 2028 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorder Complicating PregnancyStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995456
- Sponsor's protocol ID
- HDP
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivariate Analysis and Prediction of Hypertensive Disorder Complicating Pregnancy and Its Related Mechanism
- ClinicalTrials.gov ID
- NCT06995456
- Acronym / sponsor ID
- HDP
- Keywords
- HDP, gut microbiota
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 25 May 2028 (estimated)
- Study completion
- 25 May 2028 (estimated)
- First posted
- 29 May 2025 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | – | – |
| HDP group | – | –1. singleton pregnancy; 2. Those who meet the relevant diagnostic criteria in Guidelines for the Diagnosis and Treatment of Hypertensive Disorders during Pregnancy (2020). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- singleton pregnancy;
- Those who meet the relevant diagnostic criteria in Guidelines for the Diagnosis and Treatment of Hypertensive Disorders during Pregnancy (2020).
Key exclusion criteria (8 listed)
- Patients with severe cardiovascular diseases, blood system diseases and organ damage before pregnancy;
- Persons with severe mental illness;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
data of analysis of multi-omics
Time frame: Periprocedural
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Disorder Complicating Pregnancy, run by First Affiliated Hospital of Harbin Medical University.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Li Yue Li, Doctor's degree (+86-13766875068, ly99ly@hrbmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
data of analysis of multi-omics (time frame: Periprocedural). 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 29 May 2025.