Clinical trial NCT02934906: Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women
Official title: A Multi-center Prospective Cohort Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Alloimmune Thrombocytopenia
Keywords: Neonatal Alloimmune Thrombocytopenia
pregnancy
human platelet allogantigen
asian
Chinese
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
name: Shengjing Hospital
name: Qilu Hospital of Shandong University
name: Second Xiangya Hospital of Central South University
name: LanZhou University
name: The First Affiliated Hospital of Bengbu Medical University
name: The Affiliated Hospital Of Guizhou Medical University
name: Sir Run Run Shaw Hospital
name: Jilin University
name: First Affiliated Hospital of Xinjiang Medical University
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: Second Affiliated Hospital of Nanchang University
name: Guangzhou First People's Hospital
name: The Affiliated Hospital Of Southwest Medical University
name: Beijing Chao Yang Hospital
name: Qingdao University
name: Peking University First Hospital
name: RenJi Hospital
name: First Affiliated Hospital of Harbin Medical University
name: MCH Hospital of Yinchuan City
name: Henan Provincial People's Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital of Guangdong Pharmaceutical University
First posted: 2016-10-17
Enrollment: 55497
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Chinese women and their new borns

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


Eligibility criteria: 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

Primary outcomes:
measure: The positive rate of anti-HPA antibody
timeFrame: Up to one and a half years after the study completed
measure: The morbidity of NAIT
timeFrame: Up to one and a half years after the study completed
Secondary outcomes:
measure: Antigenic specificity of anti-HPA antibodies
timeFrame: Up to one and a half years after the study completed
measure: Association of anti-HPA antibody with HLA genotype as assessed by Chi-square test
timeFrame: Up to one and a half years after the study completed
measure: The relationship between the titer of anti-HPA antibody and clinical symptom severity in NAIT as assessed by Spearman Correlation assay
timeFrame: Up to one and a half years after the study completed
Other outcomes:
Locations:
Study officials:
References:
citation: Chen L, Liu Z, Liu T, Ma X, Rao M, Wang Y, Sun B, Yin W, Zhang J, Yan B, Li X, Wang Q, Zhang L, Wen J, Liu F, Wang P, Wei Y, Huang Y, Wu J, Guo Y, Kang Y, Song X, Liu X, Zhang G, Xie T, Chen Y, Zeng X, Li Z. Neonatal alloimmune thrombocytopenia caused by anti-HPA antibodies in pregnant Chinese women: a study protocol for a multicentre, prospective cohort trial. BMC Pregnancy Childbirth. 2017 Aug 31;17(1):281. doi: 10.1186/s12884-017-1453-y.