Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women

• Conditions: Neonatal Alloimmune Thrombocytopenia

• Registration Number: NCT02934906
• Lead Sponsor: Xinqiao Hospital of Chongqing

Brief Summary

This clinical study aims to investigate the anti-HPA antibodies caused neonatal alloimmune thrombocytopenia in Chinese pregnant women. The survey and data collect will help form an appropriate clinical screening procedure

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-13
• Last Update Submitted: 2016-10-13
• Study First Posted: 2016-10-17
• Last Update Posted: 2016-10-17
• Study Start: 2017-01
• Primary Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 55497

Inclusion Criteria

• 12-28 weeks pregnant Chinese women
• between Jan 1, 2017 and Dec 31, 2018

Exclusion Criteria

• Not willing to participate in this study
• Plan to terminate pregnancy early

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The positive rate of anti-HPA antibody	Up to one and a half years after the study completed
The morbidity of NAIT	Up to one and a half years after the study completed

Secondary Outcome Measures

Name	Time	Method
Antigenic specificity of anti-HPA antibodies	Up to one and a half years after the study completed
Association of anti-HPA antibody with HLA genotype as assessed by Chi-square test	Up to one and a half years after the study completed
The relationship between the titer of anti-HPA antibody and clinical symptom severity in NAIT as assessed by Spearman Correlation assay	Up to one and a half years after the study completed