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Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women

Establish the Reference Range of Antiphospholipid Antibody in Healthy Preganany Women: The Prospective Studies for Antiphospholipid Syndrome Related Pregancy Loss

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05883189
Enrollment
300
Registered
2023-05-31
Start date
2023-05-20
Completion date
2024-02-28
Last updated
2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus Health Pregancy Women

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTDraw blood

Draw blood from human body and make into serum to test

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

1. Thrombosis history 2. Rheumatic immune disease 3. Use oral contraception or biological inhibitors 4. History of abortion, adverse pregnancy outcome, common high blood pressure, diabetes

Design outcomes

Primary

MeasureTime frameDescription
95th and 99th pencentile data of pregancy and non-pregancy womenOct. 202395th and 99th pencentile data of pregancy and non-pregancy women, and the prevalence of aPLs

Contacts

Primary ContactHui Chen
zheling76@163.com13826445092

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026