PreeclampsiaNCT06205771
The Role and Mechanism of GPER-Hippo-CBS/H2S Pathway in Preeclampsia
A study testing H2S content in people with Preeclampsia, run by Hao Feng at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about in health conditions. The main questions it aims to answer are: The pathological significance of GPER in uterine artery dilation in preeclampsia The Mechanism of GPER Hippo Pathway Regulating CBS/H2S in Human Uterine Artery Smooth Muscle Cells (hUASMC) This project… Read more about this study
- Who is it for?
- Ages Up to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- H2S content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2024to Dec 2029
- Phase
- Interventional
- 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 Up to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Full term pregnancy with clinical diagnosis of preeclampsia and normal pregnancy pregnant woman
- Pregnant women undergoing lower segment cesarean section for delivery
Who cannot join
- Combined with chronic hypertension, kidney disease, intrahepatic cholestasis, etc Other basic diseases;
- Multiple pregnancy
- Pregnant women undergoing vaginal delivery
- Normal pregnant women who are<37 weeks or>40 weeks pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Shandong First Medical University &Shandong Provincial Qianfoshan Hospital
Jinan, Please Select, 250000
About this study
Official title: The Role and Mechanism of GPER Hippo Pathway in Regulating Uterine Arterial Smooth Muscle CBS/H2S in the Pathogenesis of Preeclampsia
The goal of this clinical trial is to learn about in health conditions. The main questions it aims to answer are:
- The pathological significance of GPER in uterine artery dilation in preeclampsia
- The Mechanism of GPER Hippo Pathway Regulating CBS/H2S in Human Uterine Artery Smooth Muscle Cells (hUASMC) This project intends to use GPER interfering RNA, YAP1 interfering RNA, in vivo perfusion experiments of human uterine artery tissue, and single cell patch clamp technology to study hypotheses under physiological/pathological pregnancy conditions at the tissue, cellular, and molecular levels, revealing a novel signal transduction pathway of estrogen stimulating vasodilation, providing new ideas for studying the mechanism of uterine artery blood flow regulation. This research result will provide new targets for intervention and treatment of diseases such as fetal intrauterine growth retardation and preeclampsia.
Read the detailed description
- Measure the content of H2S in uterine arterial smooth muscle and circulation of normal pregnancy and PE pregnant women, and analyze the relationship between the content of H2S in uterine arterial smooth muscle and circulation of PE pregnant women and PE.
- Knock down the GPER and overexpression of GPER in HTR-8 cells, and detect the expression of GPER, CBS, and Hippo pathway related proteins using Western blot and qRT-PCR to verify the efficiency of knockdown and overexpression. Use different concentrations of H2S donor (GYY4137) to interfere with HTR-8 cells after treatment, and use RT-PCR and Western blot to detect the mRNA and protein expression of downstream molecules YAP and TAZ in Hippo pathway in cells, respectively.
- Conditions
- Preeclampsia
- Being tested
- H2S content
- Keywords
- preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H2S contentOther
H2S content
| Study group | Role | What they receive |
|---|---|---|
| NP | No intervention | normal pregnancy and preeclampsia pregnancy |
| PE | Experimental | preeclampsia Receives: Other: H2S content |
What is being measured
The primary outcome is the main question the study is designed to answer.
H2S content in uterine arterial smooth muscle circulation
H2S content in circulation
Measured: 8:00 am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start10 Apr 2024 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hao Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hao Feng, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205771
- Sponsor's protocol ID
- YXLL-KY-2023（031）
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 10 Apr 2024
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role and Mechanism of GPER Hippo Pathway in Regulating Uterine Arterial Smooth Muscle CBS/H2S in the Pathogenesis of Preeclampsia
- ClinicalTrials.gov ID
- NCT06205771
- Acronym / sponsor ID
- YXLL-KY-2023（031）
- Conditions
- Preeclampsia
- Keywords
- preeclampsia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Hao FengUniversity, hospital or other
- Study start
- 10 Apr 2024 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 Jan 2024 (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.
The goal of this clinical trial is to learn about in health conditions. The main questions it aims to answer are:
- The pathological significance of GPER in uterine artery dilation in preeclampsia
- The Mechanism of GPER Hippo Pathway Regulating CBS/H2S in Human Uterine Artery Smooth Muscle Cells (hUASMC) This project intends to use GPER interfering RNA, YAP1 interfering RNA, in vivo perfusion experiments of human uterine artery tissue, and single cell patch clamp technology to study hypotheses under physiological/pathological pregnancy conditions at the tissue, cellular, and molecular levels, revealing a novel signal transduction pathway of estrogen stimulating vasodilation, providing new ideas for studying the mechanism of uterine artery blood flow regulation. This research result will provide new targets for intervention and treatment of diseases such as fetal intrauterine growth retardation and preeclampsia.
Detailed description
- Measure the content of H2S in uterine arterial smooth muscle and circulation of normal pregnancy and PE pregnant women, and analyze the relationship between the content of H2S in uterine arterial smooth muscle and circulation of PE pregnant women and PE.
- Knock down the GPER and overexpression of GPER in HTR-8 cells, and detect the expression of GPER, CBS, and Hippo pathway related proteins using Western blot and qRT-PCR to verify the efficiency of knockdown and overexpression. Use different concentrations of H2S donor (GYY4137) to interfere with HTR-8 cells after treatment, and use RT-PCR and Western blot to detect the mRNA and protein expression of downstream molecules YAP and TAZ in Hippo pathway in cells, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NP | No intervention | –normal pregnancy and preeclampsia pregnancy |
| PE | Experimental | Other: H2S contentpreeclampsia |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Full term pregnancy with clinical diagnosis of preeclampsia and normal pregnancy pregnant woman
- Pregnant women undergoing lower segment cesarean section for delivery
Key exclusion criteria (4 listed)
- Combined with chronic hypertension, kidney disease, intrahepatic cholestasis, etc Other basic diseases;
- Multiple pregnancy
- Pregnant women undergoing vaginal delivery
- Normal pregnant women who are<37 weeks or>40 weeks pregnant
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 |
|---|---|---|
| H2S contentH2S content | Other | PE |
Primary outcome
H2S content in uterine arterial smooth muscle circulation
Time frame: 8:00 am
H2S content in circulation
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 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H2S content in people with Preeclampsia, run by Hao Feng 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 10 Apr 2024. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H2S content in uterine arterial smooth muscle circulation (time frame: 8:00 am). 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 10 Apr 2024.