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Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women

NCT ID: NCT05883189

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-20

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Focus Health Pregancy Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group1: non-pregancy health women.

Draw blood

Intervention Type DIAGNOSTIC_TEST

Draw blood from human body and make into serum to test

Group 2:Pregancy health women.

Draw blood

Intervention Type DIAGNOSTIC_TEST

Draw blood from human body and make into serum to test

Group 3: Diagnosed Antiphospholipid syndrome patients

Draw blood

Intervention Type DIAGNOSTIC_TEST

Draw blood from human body and make into serum to test

Interventions

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Draw blood

Draw blood from human body and make into serum to test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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chenhui79

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hui Chen

Role: CONTACT

Phone: 13826445092

Email: [email protected]

Other Identifiers

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SYSKY-2022-412-01

Identifier Type: -

Identifier Source: org_study_id