Obstetrics, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.
Department of Experimental Immunohematology, Sanquin, Amsterdam, The Netherlands.
BMJ Open. 2020 Jul 20;10(7):e034071. doi: 10.1136/bmjopen-2019-034071.
Fetal and neonatal alloimmune thrombocytopenia (FNAIT) may lead to severe fetal or neonatal bleeding and/or perinatal death. Maternal alloantibodies, targeted against fetal human platelet antigens (HPAs), can result thrombocytopenia and bleeding complications. In pregnancies with known immunisation, fetal bleeding can be prevented by weekly maternal intravenous immunoglobulin infusions. Without population-based screening, immunisation is only detected after birth of an affected infant. Affected cases that might have been prevented, when timely identified through population-based screening. Implementation is hampered by the lack of knowledge on incidence, natural history and identification of pregnancies at high risk of bleeding. We designed a study aimed to obtain this missing knowledge.
The HIP (HPA-screening in pregnancy) study is a nationwide, prospective and observational cohort study aimed to assess incidence and natural history of FNAIT as well as identifying pregnancies at high risk for developing bleeding complications. For logistic reasons, we invite rhesus D-negative or rhesus c-negative pregnant women, who take part in the Dutch population-based prenatal screening programme for erythrocyte immunisation, to participate in our study. Serological HPA-1a typing is performed and a luminex-based multiplex assay will be performed for the detection of anti-HPA-1a antibodies. Results will not be communicated to patients or caregivers. Clinical data of HPA-1a negative women and an HPA-1a positive control group will be collected after birth. Samples of HPA-1a immunised pregnancies with and without signs of bleeding will be compared with identify parameters for identification of pregnancies at high risk for bleeding complications.
Ethical approval for this study has been obtained from the Medical Ethical Committee Leiden-The Hague-Delft (P16.002). Study enrolment began in March 2017. All pregnant women have to give informed consent for testing according to the protocol. Results of the study will be disseminated through congresses and publication in relevant peer-reviewed journals.
NCT04067375.
胎儿和新生儿同种免疫性血小板减少症（FNAIT）可导致严重的胎儿或新生儿出血和/或围产儿死亡。针对胎儿人类血小板抗原（HPAs）的母体同种抗体可导致血小板减少和出血并发症。在已知免疫的妊娠中，通过每周给母体静脉内输注免疫球蛋白可预防胎儿出血。如果没有进行基于人群的筛查，则只有在患有该病的婴儿出生后才能检测到免疫。如果通过基于人群的筛查及时识别出可能患病的病例，则可以预防这些受影响的病例。由于缺乏关于发病率、自然病史和识别高出血风险妊娠的知识，实施受到阻碍。我们设计了一项研究以获取这些缺失的知识。
HIP（妊娠期间 HPA 筛查）研究是一项全国性、前瞻性和观察性队列研究，旨在评估 FNAIT 的发病率和自然病史，并确定发生出血并发症高风险的妊娠。出于逻辑原因，我们邀请 RhD 阴性或 RhC 阴性的孕妇参加我们的研究，这些孕妇参加了荷兰基于人群的红细胞免疫产前筛查计划。将进行血清学 HPA-1a 分型，并将进行 Luminex 基于的多重分析以检测抗-HPA-1a 抗体。结果不会告知患者或护理人员。在分娩后将收集 HPA-1a 阴性妇女和 HPA-1a 阳性对照组的临床数据。将比较 HPA-1a 免疫妊娠有和无出血迹象的样本，以确定识别高出血风险妊娠的参数。
这项研究已获得莱顿-海牙-代尔夫特医学伦理委员会（P16.002）的批准。研究招募于 2017 年 3 月开始。所有孕妇都必须根据方案同意进行检测。研究结果将通过会议和在相关同行评议期刊上发表进行传播。
NCT04067375。
Zotero 插件