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Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05883189
Collaborator
(none)
300
Enrollment
9.3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Draw blood

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Establish the Reference Range of Antiphospholipid Antibody in Healthy Preganany Women: The Prospective Studies for Antiphospholipid Syndrome Related Pregancy Loss
Anticipated Study Start Date :
May 20, 2023
Anticipated Primary Completion Date :
Oct 7, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Group1: non-pregancy health women.

Diagnostic Test: Draw blood
Draw blood from human body and make into serum to test
Group 2:Pregancy health women.

Diagnostic Test: Draw blood
Draw blood from human body and make into serum to test
Group 3: Diagnosed Antiphospholipid syndrome patients

Diagnostic Test: Draw blood
Draw blood from human body and make into serum to test

Outcome Measures

Primary Outcome Measures

  1. 95th and 99th pencentile data of pregancy and non-pregancy women [Oct. 2023]

    95th and 99th pencentile data of pregancy and non-pregancy women, and the prevalence of aPLs

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
chenhui79, Chief Physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05883189
Other Study ID Numbers:
  • SYSKY-2022-412-01
First Posted:
May 31, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of May 31, 2023