Maternal Fetal Medicine Unit, Department of Obstetrics; Universitat Autònoma de Barcelona, Hospital Vall d'Hebron, Barcelona, Spain.
Maternal Fetal Medicine Unit, Department of Obstetrics; Universitat Autònoma de Barcelona, Hospital Vall d'Hebron, Barcelona, Spain
BMJ Open. 2023 Jul 19;13(7):e071997. doi: 10.1136/bmjopen-2023-071997.
Congenital cytomegalovirus (cCMV) is the leading cause of non-genetic sensorineural hearing loss and one of the main causes of neurological disability. Despite this, no universal screening programme for cCMV has been implemented in Spain. A recent study has shown that early treatment with valaciclovir, initiated in the first trimester and before the onset of signs in the fetus, reduces the risk of fetal infection. This finding favours the implementation of a universal screening programme for cCMV.The aim of this study is to evaluate the performance of a universal screening programme for cCMV during the first trimester of pregnancy in a primary care setting.
This is an observational multicentre cohort study. The study will be conducted in four primary care settings from the Northern Metropolitan Barcelona area and three related hospitals and will last 3 years and will consist of a recruitment period of 18 months.In their first pregnancy visit, pregnant women will be offered to add a CMV serology test to the first trimester screening tests. Pregnant women with primary infection will be referred to the reference hospital, where they will continue treatment and follow-up according to the clinical protocol of the referral hospital, which includes treatment with valacyclovir. A CMV-PCR will be performed at birth on newborns of mothers with primary infection, and those who are infected will undergo neonatal follow-up for at least 12 months of life.For the analysis, the acceptance rate, the prevalence of primary CMV infections and the CMV seroprevalence in the first trimester of pregnancy will be studied.
Ethical approval was obtained from the University Institute Foundation for Primary Health Care Research Jordi Gol i Gurina Ethics Committee 22/097-P dated 27 April 2022.
先天性巨细胞病毒（cCMV）是导致非遗传性感觉神经性听力损失的主要原因之一，也是导致神经功能障碍的主要原因之一。尽管如此，西班牙尚未实施针对 cCMV 的普遍筛查计划。最近的一项研究表明，在胎儿出现症状之前的妊娠早期，用伐昔洛韦进行早期治疗可以降低胎儿感染的风险。这一发现有利于实施针对 cCMV 的普遍筛查计划。本研究旨在评估在初级保健环境中，妊娠早期针对 cCMV 的普遍筛查计划的性能。
这是一项观察性多中心队列研究。该研究将在巴塞罗那北部大都市区的四个初级保健机构和三个相关医院进行，持续 3 年，包括 18 个月的招募期。在首次妊娠就诊时，将向孕妇提供在孕早期筛查试验中添加 CMV 血清学检测的机会。原发性感染的孕妇将被转介到参考医院，在那里他们将根据参考医院的临床方案继续治疗和随访，包括使用伐昔洛韦治疗。对于原发性感染的母亲的新生儿，将在出生时进行 CMV-PCR，如果感染，将进行新生儿随访，至少随访 12 个月。对于分析，将研究接受率、原发性 CMV 感染的患病率和妊娠早期的 CMV 血清阳性率。
2022 年 4 月 27 日，获得了大学研究所基础初级卫生保健研究 Jordi Gol i Gurina 伦理委员会 22/097-P 的伦理批准。
