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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Li Chen, Zhiwei Liu, Tiemei Liu, Xianjun Ma, Meiying Rao, Yongjun Wang, Bo Sun, Wen Yin, Jun Zhang, Beizhan Yan, Xiaojuan Li, Qiushi Wang, Lei Zhang, Jun Wen, Fenghua Liu, Peng Wang, Yaming Wei, Yuanshuai Huang, Jiang Wu, Yi Guo, Yinlan Kang, Xiaochuan Song, Xiangfu Liu, Genling Zhang, Tingting Xie, Yonggeng Chen, Xiaojing Zeng, Zhongjun Li

Published in: BMC Pregnancy and Childbirth | Issue 1/2017

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Abstract

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).
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Metadata
Title
Neonatal alloimmune thrombocytopenia caused by anti-HPA antibodies in pregnant Chinese women: a study protocol for a multicentre, prospective cohort trial
Authors
Li Chen
Zhiwei Liu
Tiemei Liu
Xianjun Ma
Meiying Rao
Yongjun Wang
Bo Sun
Wen Yin
Jun Zhang
Beizhan Yan
Xiaojuan Li
Qiushi Wang
Lei Zhang
Jun Wen
Fenghua Liu
Peng Wang
Yaming Wei
Yuanshuai Huang
Jiang Wu
Yi Guo
Yinlan Kang
Xiaochuan Song
Xiangfu Liu
Genling Zhang
Tingting Xie
Yonggeng Chen
Xiaojing Zeng
Zhongjun Li
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2017
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-017-1453-y

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