Antiphospholipid Syndrome in PregnancyNCT05378516
Placental Pathology and Inflammatory Factor Analysis of OAPS
An observational study of Antiphospholipid Syndrome in Pregnancy, run by Peking University People's Hospital at 1 site in China.
Trial summary
This investigation is on placental pathological changes and inflammatory factors associated with obstetric antiphospholipid syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antiphospholipid Syndrome in Pregnancy
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women with antiphospholipid syndrome (diagnosed by experts with clinical evidence) and healthy pregnant women without antiphospholipid syndrome as a control group
Who may be able to join
- 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
Who cannot join
- pregnant women with other autoimmune diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PekingUPH
Beijing
Jingjing Yang, doctor, 008613810625484, yjjbear2013@126.com
Xinyang Ma, bachelor, 008618801152801, 2948138462@qq.com
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- Antiphospholipid Syndrome in Pregnancy
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| obstetric antiphospholipid syndrome | obstetric antiphospholipid syndrome 20 cases and normal pregnant women 20 cases Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
expression of ACC1 in placenta in pregnancy with/without antiphospholipid syndrome
Measured: in two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jan 2022
- Primary completion12 May 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid Syndrome in PregnancyStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jingjing, Peking University People's Hospital
- Investigators
- Jingjing Yang, doctor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378516
- Sponsor's protocol ID
- yjjbear2022
- Status last verified
- Jan 2022
- First submitted
- 12 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Pathology and Inflammatory Factor Analysis of Obstetric Antiphospholipid Syndrome Patients
- ClinicalTrials.gov ID
- NCT05378516
- Acronym / sponsor ID
- yjjbear2022
- Conditions
- Antiphospholipid Syndrome in Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 May 2022 (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.
This investigation is on placental pathological changes and inflammatory factors associated with obstetric antiphospholipid syndrome.
Detailed description
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obstetric antiphospholipid syndrome | – | Other: no interventionobstetric antiphospholipid syndrome 20 cases and normal pregnant women 20 cases |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women with antiphospholipid syndrome (diagnosed by experts with clinical evidence) and healthy pregnant women without antiphospholipid syndrome as a control group
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- pregnant women with other autoimmune diseases
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 |
|---|---|---|
| no interventionno intervention | Other | obstetric antiphospholipid syndrome |
Primary outcome
expression of ACC1 in placenta in pregnancy with/without antiphospholipid syndrome
Time frame: in two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jingjing Yang, doctor principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome in Pregnancy, run by Peking University People's Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 18 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingjing Yang, deputy chief physician, doctor (0086-13810625484, yjjbear2013@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expression of ACC1 in placenta in pregnancy with/without antiphospholipid syndrome (time frame: in two years). 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 18 May 2022.