Neonatal Alloimmune Thrombocytopenia Clinical Trial
Official title:
A Multi-center Prospective Cohort Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women
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
| Status | Not yet recruiting |
| Enrollment | 55497 |
| Est. completion date | |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Xinqiao Hospital of Chongqing | Beijing Chao Yang Hospital, First Affiliated Hospital Bengbu Medical College, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, Fourth Military Medical University, Guangzhou First Municipal People’s Hospital, Henan Province People's Hospital, Jilin University, LanZhou University, MCH Hospital of Yinchuan City, Peking University First Hospital, Qilu Hospital, Qingdao University, RenJi Hospital, Second Affiliated Hospital of Nanchang University, Second Xiangya Hospital of Central South University, Shengjing Hospital, Sir Run Run Shaw Hospital, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Hospital Of Southwest Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University, The People's hospital of Xinjiang autonomous region, Third Affiliated Hospital, Sun Yat-Sen University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The positive rate of anti-HPA antibody | Up to one and a half years after the study completed | No | |
| Primary | The morbidity of NAIT | Up to one and a half years after the study completed | No | |
| Secondary | Antigenic specificity of anti-HPA antibodies | Up to one and a half years after the study completed | No | |
| Secondary | 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 | No | |
| Secondary | 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 | No |