Focus Health Pregancy WomenNCT05883189
Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women
An observational study of Focus Health Pregancy Women, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
The study is aim to establish 95th and 99th percentile for healthy pregancy women for antiphospholipid antibodies(aPLs), such as aCL IgG/M/A, B2GP1 IgG/M/A, aPS/PT IgG/M. The outcome of the study is expected to aid Antiphospholipid syndrome patients diagnosis and managment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Focus Health Pregancy Women
- What is being tested?
- Draw blood
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2023to 28 Feb 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 1. Non-pregnant healthy women, Age 18-45; 2. Pregnant women, Age 18-45, follow through the pregnancy and successful delivery 3. APS pregnant patients diagnosed by clinical department
Who may be able to join
- 120 non-pregnant healthy women, Age 18-45, with at least 1 successful pregnancy , no history of adverse pregnancy outcome, no abortion, still birth, premature delivery, preeclampsia
- 120 pregnant women, Age 18-45, follow through the pregnancy and successful delivery without any adverse pregnancy outcome during the pregnancy process, no abortion, still birth, premature delivery, preeclampsia, no drug treatment
- 60 APS pregnant patients diagnosed by clinical department
Who cannot join
- Thrombosis history
- Rheumatic immune disease
- Use oral contraception or biological inhibitors
- History of abortion, adverse pregnancy outcome, common high blood pressure, diabetes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Establish the Reference Range of Antiphospholipid Antibody in Healthy Preganany Women: The Prospective Studies for Antiphospholipid Syndrome Related Pregancy Loss
The study is aim to establish 95th and 99th percentile for healthy pregancy women for antiphospholipid antibodies(aPLs), such as aCL IgG/M/A, B2GP1 IgG/M/A, aPS/PT IgG/M. The outcome of the study is expected to aid Antiphospholipid syndrome patients diagnosis and managment. We also include some obstetirc Antiphospholipid syndrome(APS) patients to analysis the correlation between antiphospholipid antibodies and pregancy outcome, also want to know the prevalenc of aPLs, which can be guide for clinical application for APS diagnosis and treatment.
- Conditions
- Focus Health Pregancy Women
- Being tested
- Draw blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Draw bloodDiagnostic test
Draw blood from human body and make into serum to test
| Study group | Role | What they receive |
|---|---|---|
| Group1: non-pregancy health women. | Not described Receives: Diagnostic Test: Draw blood | |
| Group 2:Pregancy health women. | Not described Receives: Diagnostic Test: Draw blood | |
| Group 3: Diagnosed Antiphospholipid syndrome patients | Not described Receives: Diagnostic Test: Draw blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
95th and 99th pencentile data of pregancy and non-pregancy women
95th and 99th pencentile data of pregancy and non-pregancy women, and the prevalence of aPLs
Measured: Oct. 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start20 May 2023 (estimated)
- Primary completion7 Oct 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus Health Pregancy WomenStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chenhui79, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883189
- Sponsor's protocol ID
- SYSKY-2022-412-01
- Status last verified
- May 2023
- First submitted
- 20 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish the Reference Range of Antiphospholipid Antibody in Healthy Preganany Women: The Prospective Studies for Antiphospholipid Syndrome Related Pregancy Loss
- ClinicalTrials.gov ID
- NCT05883189
- Acronym / sponsor ID
- SYSKY-2022-412-01
- Conditions
- Focus Health Pregancy Women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (estimated)
- Primary completion
- 7 Oct 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 31 May 2023 (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 study is aim to establish 95th and 99th percentile for healthy pregancy women for antiphospholipid antibodies(aPLs), such as aCL IgG/M/A, B2GP1 IgG/M/A, aPS/PT IgG/M. The outcome of the study is expected to aid Antiphospholipid syndrome patients diagnosis and managment. We also include some obstetirc Antiphospholipid syndrome(APS) patients to analysis the correlation between antiphospholipid antibodies and pregancy outcome, also want to know the prevalenc of aPLs, which can be guide for clinical application for APS diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1: non-pregancy health women. | – | Diagnostic Test: Draw blood |
| Group 2:Pregancy health women. | – | Diagnostic Test: Draw blood |
| Group 3: Diagnosed Antiphospholipid syndrome patients | – | Diagnostic Test: Draw blood |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Non-pregnant healthy women, Age 18-45; 2. Pregnant women, Age 18-45, follow through the pregnancy and successful delivery 3. APS pregnant patients diagnosed by clinical department
Key inclusion criteria (3 listed)
- 120 non-pregnant healthy women, Age 18-45, with at least 1 successful pregnancy , no history of adverse pregnancy outcome, no abortion, still birth, premature delivery, preeclampsia
- 120 pregnant women, Age 18-45, follow through the pregnancy and successful delivery without any adverse pregnancy outcome during the pregnancy process, no abortion, still birth, premature delivery, preeclampsia, no drug treatment
- 60 APS pregnant patients diagnosed by clinical department
Key exclusion criteria (4 listed)
- Thrombosis history
- Rheumatic immune disease
- Use oral contraception or biological inhibitors
- History of abortion, adverse pregnancy outcome, common high blood pressure, diabetes
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 |
|---|---|---|
| Draw bloodDraw blood from human body and make into serum to test | Diagnostic test | Group 2:Pregancy health women., Group 3: Diagnosed Antiphospholipid syndrome patients, Group1: non-pregancy health women. |
Primary outcome
95th and 99th pencentile data of pregancy and non-pregancy women
Time frame: Oct. 2023
95th and 99th pencentile data of pregancy and non-pregancy women, and the prevalence of aPLs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus Health Pregancy Women, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 3 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: status not confirmed, as of the sponsor's last update on 31 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Chen (13826445092, zheling76@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
95th and 99th pencentile data of pregancy and non-pregancy women (time frame: Oct. 2023). 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 31 May 2023.