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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Focus Health Pregancy Women
• Intervention / Treatment: Diagnostic test: Draw blood

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Hui Chen; Phone Number: 13826445092; Email: zheling76@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2023
• Primary Completion (Estimated): October 7, 2023
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: May 20, 2023
• First Submitted That Met QC Criteria: May 20, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SYSKY-2022-412-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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