Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women

NCT05883189 | Unknown FDA Device

• 1 other identifier: SYSKY-2022-412-01
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Focus Health Pregancy Women

Outcome Measures

Primary Outcomes (1)

• 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

  Oct. 2023

Study Arms (3)

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

Interventions

Draw blood DIAGNOSTIC_TEST

Draw blood from human body and make into serum to test

Group 2:Pregancy health women.; Group 3: Diagnosed Antiphospholipid syndrome patients; Group1: non-pregancy health women.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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
• 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
• APS pregnant patients diagnosed by clinical department

You may not qualify if:

• Thrombosis history
• Rheumatic immune disease
• Use oral contraception or biological inhibitors
• History of abortion, adverse pregnancy outcome, common high blood pressure, diabetes

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Central Study Contacts

Hui Chen

CONTACT

13826445092; zheling76@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: May 31, 2023
• Study Start: May 20, 2023
• Primary Completion: October 7, 2023
• Study Completion: February 28, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05