NCT06205771

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
43mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Apr 2024Dec 2029

First Submitted

Initial submission to the registry

January 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 10, 2024

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 10, 2024

Status Verified

January 1, 2024

Enrollment Period

5.5 years

First QC Date

January 4, 2024

Last Update Submit

April 8, 2024

Conditions

Keywords

preeclampsia

Outcome Measures

Primary Outcomes (1)

  • H2S content in uterine arterial smooth muscle circulation

    H2S content in circulation

    8:00 am

Study Arms (2)

NP

NO INTERVENTION

normal pregnancy and preeclampsia pregnancy

PE

EXPERIMENTAL

preeclampsia

Other: H2S content

Interventions

H2S content

PE

Eligibility Criteria

AgeUp to 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Full term pregnancy with clinical diagnosis of preeclampsia and normal pregnancy pregnant woman
  • Pregnant women undergoing lower segment cesarean section for delivery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University &Shandong Provincial Qianfoshan Hospital

Jinan, Please Select, 250000, China

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 16, 2024

Study Start

April 10, 2024

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 10, 2024

Record last verified: 2024-01

Locations