- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05378516
Placental Pathology and Inflammatory Factor Analysis of OAPS
May 12, 2022 updated by: Yang Jingjing, Peking University People's Hospital
Placental Pathology and Inflammatory Factor Analysis of Obstetric Antiphospholipid Syndrome Patients
This investigation is on placental pathological changes and inflammatory factors associated with obstetric antiphospholipid syndrome.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
1. To clarify the correlation between antiphospholipid antibody, ACC1 expression level, Treg cell and placental pathological changes associated with antiphospholipid syndrome.
2. Reveal that antiphospholipid antibodies affect Treg cell differentiation through the key enzyme of lipid metabolism ACC1.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jingjing Yang, deputy chief physician, doctor
- Phone Number: 0086-13810625484
- Email: yjjbear2013@126.com
Study Contact Backup
- Name: Xinyang Ma, resident, bachelor
- Phone Number: 0086-18801152801
- Email: 2948138462@qq.com
Study Locations
-
-
-
Pekin, China
- Recruiting
- PekingUPH
-
Contact:
- Jingjing Yang, doctor
- Phone Number: 008613810625484
- Email: yjjbear2013@126.com
-
Contact:
- Xinyang Ma, bachelor
- Phone Number: 008618801152801
- Email: 2948138462@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
pregnant women with antiphospholipid syndrome (diagnosed by experts with clinical evidence) and healthy pregnant women without antiphospholipid syndrome as a control group
Description
Inclusion Criteria:
- pregnant women with antiphospholipid syndrome (diagnosed by experts with clinical evidence) and healthy pregnant women without antiphospholipid syndrome as a control group
- consent to join this study and finish the informed consents
Exclusion Criteria:
pregnant women with other autoimmune diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
obstetric antiphospholipid syndrome
obstetric antiphospholipid syndrome 20 cases and normal pregnant women 20 cases
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
expression of ACC1 in placenta in pregnancy with/without antiphospholipid syndrome
Time Frame: in two years
|
in two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jingjing Yang, doctor, Peking University People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
May 12, 2022
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
May 12, 2022
First Submitted That Met QC Criteria
May 12, 2022
First Posted (Actual)
May 18, 2022
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 12, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- yjjbear2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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