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Not yet recruitingNCT05883189Updated May 31, 2023

Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women

An observational study in Focus Health Pregancy Women, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Focus Health Pregancy Women
03

In context

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testDraw blood

    Draw blood from human body and make into serum to test

06

What researchers measure

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

    Time frame: Oct. 2023

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05883189
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Responsible party
chenhui79 (Chief Physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University) — Principal investigator
First posted
May 31, 2023
Start date
May 20, 2023 (estimated)
Primary completion
Oct 7, 2023 (estimated)
Completion
Feb 28, 2024 (estimated)
Last update
May 31, 2023

Study contacts

Hui Chen
Contact
zheling76@163.com
13826445092

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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