Neonatal alloimmune thrombocytopenia caused by anti-HPA antibodies in pregnant Chinese women: a study protocol for a multicentre, prospective cohort trial

Autor: Tingting Xie, Jun Wen, Jun Zhang, Yonggeng Chen, Xianjun Ma, Fenghua Liu, Yinlan Kang, Beizhan Yan, Xiaojing Zeng, Li Chen, Wen Yin, Xiaochuan Song, Yaming Wei, Meiying Rao, Xiangfu Liu, Genling Zhang, Zhongjun Li, Lei Zhang, Huang Yuanshuai, Xiaojuan Li, Qiushi Wang, Peng Wang, Jiang Wu, Yongjun Wang, Sun Bo, Yi Guo, Tiemei Liu, Zhiwei Liu
Jazyk: angličtina
Rok vydání: 2017
Předmět:
China
medicine.medical_specialty
endocrine system
Genotype
Population
Reproductive medicine
Gestational Age
030204 cardiovascular system & hematology
lcsh:Gynecology and obstetrics
Neonatal Alloimmune thrombocytopenia
Study Protocol
03 medical and health sciences
Fetus
0302 clinical medicine
Asian People
Clinical Protocols
Isoantibodies
Pregnancy
Risk Factors
medicine
Humans
Antigens
Human Platelet
Prospective Studies
education
Prospective cohort study
lcsh:RG1-991
education.field_of_study
biology
Human leukocyte antigen
Obstetrics
business.industry
Incidence (epidemiology)
Infant
Newborn
Obstetrics and Gynecology
Gestational age
medicine.disease
Human platelet antigen
Thrombocytopenia
Neonatal Alloimmune
Immunology
Neonatal alloimmune thrombocytopenia
biology.protein
Female
Pregnancy Trimesters
Antibody
business
030215 immunology
Zdroj: BMC Pregnancy and Childbirth, Vol 17, Iss 1, Pp 1-5 (2017)
BMC Pregnancy and Childbirth
ISSN: 1471-2393
0293-4906
DOI: 10.1186/s12884-017-1453-y
Popis: Background Neonatal alloimmune thrombocytopenia (NAIT), caused by maternal antibodies raised against alloantigens carried on foetal platelets, is a very common haematological abnormality in newborns worldwide. However, baseline data on NAIT in China are lacking. Therefore, this study seeks to explore the incidence of alloantibody against the human platelet antigen (HPA) in pregnant women and its associations with NAIT in China. Methods A multicentre, prospective cohort study design will be used, and 55,497 pregnant women will be recruited for the first screening of the anti-HPA antibody at 12 to 28 weeks of gestational age. Subjects who are positive in the first screening for the anti-HPA antibody will be included in the exposure group. Re-tests of the antibody titre, antigen-specificity and genotyping of HPA and HLA will be conducted during admission. A ratio of 1:1 paired individuals with the same ethnicity and parity but testing negative for the anti-HPA antibody will be randomly selected to be included in the non-exposure group. NAIT will be diagnosed in the newborns on day one of the birth. The HPA of the neonates in the exposure group will also be genotyped by sequencing. Associations of maternal HLA with the occurrence of the anti-HPA antibody and correlation of the severity of NAIT with the titre of the anti-HPA antibody will be further analysed. Discussion The study is expected to provide baseline data on NAIT in China. Besides, we hope to find out a population who expresses particular HLA molecules has significant higher risk of HPA alloimmunization in Chinese individuals. We also hope to find a Chinese-specific cut-off antibody titre for the prediction of the severity of NAIT and to provide a means to evaluate the necessity of antenatal treatment. Trial registration ClinicalTrials.gov: NCT02934906 (date registered: 13.10.2016).
Databáze: OpenAIRE
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