Paediatric Infectious Diseases Research Group, St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK.
St George's University Hospitals NHS Foundation Trust, London, UK.
BMC Pregnancy Childbirth. 2021 Aug 18;21(1):565. doi: 10.1186/s12884-021-03979-z.
Congenital cytomegalovirus (CMV) is the most common congenital infection globally, however information about CMV is not routinely included in antenatal education in the United Kingdom. This feasibility study aimed to gather the essential data needed to design and power a large randomised controlled trial (RCT) to investigate the efficacy of a digital intervention in reducing the risk of CMV acquisition in pregnancy. In order to do this, we carried out a single-centre RCT, which explored the knowledge, attitudes and risk reduction behaviours in women in the intervention and treatment as usual groups, pre- and post-intervention.
CMV seronegative women living with a child less than four years old, receiving antenatal care at a single UK tertiary centre, were randomised to the digital intervention or 'treatment as usual' groups. Participants completed questionnaires before the digital intervention and after and at 34 gestational weeks, and responses within groups and between groups were compared using tailored randomisation tests. CMV serology was tested in the first trimester and at the end of pregnancy.
Of the 878 women screened, 865 samples were analysed with 43% (n = 372) being CMV seronegative and therefore eligible to take part in the RCT; of these, 103 (27.7%) women were enrolled and 87 (84%) of these completed the study. Most participants (n = 66; 64%) were unfamiliar with CMV at enrolment, however at 34 gestational weeks, women in the intervention group (n = 51) were more knowledgeable about CMV compared to the treatment as usual group (n = 52) and reported engaging in activities that may increase the risk of CMV transmission less frequently. The digital intervention was highly acceptable to pregnant women. Overall, four participants seroconverted over the course of the study: two from each study group.
A large multi-centre RCT investigating the efficacy of a CMV digital intervention is feasible in the United Kingdom; this study has generated essential data upon which to power such a study. This single-centre feasibility RCT demonstrates that a digital educational intervention is associated with increase in knowledge about CMV and can result in behaviour change which may reduce the risk of CMV acquisition in pregnancy.
Clinicaltrials.gov, NCT03511274 , Registered 27.04.18, http://www.Clinicaltrials.gov.
先天性巨细胞病毒（CMV）是全球最常见的先天性感染，但在英国，产前教育中通常不包括 CMV 信息。这项可行性研究旨在收集设计和实施大型随机对照试验（RCT）所需的基本数据，以调查数字干预措施在降低妊娠期间 CMV 感染风险方面的疗效。为此，我们进行了一项单中心 RCT，该 RCT 探讨了干预组和常规治疗组妇女在干预前后的知识、态度和降低风险行为。
CMV 血清阴性、在英国一家三级中心接受产前护理、与小于 4 岁儿童同住的妇女被随机分配到数字干预组或“常规治疗”组。参与者在数字干预前和干预后以及妊娠 34 周时完成问卷，使用定制随机化检验比较组内和组间的反应。在孕早期和妊娠末期检测 CMV 血清学。
在 878 名筛查妇女中，对 865 个样本进行了分析，其中 43%（n=372）为 CMV 血清阴性，因此有资格参加 RCT；其中，103 名（27.7%）妇女入组，87 名（84%）完成了研究。大多数参与者（n=66；64%）在入组时对 CMV 不熟悉，但在妊娠 34 周时，干预组（n=51）的妇女比常规治疗组（n=52）更了解 CMV，并且报告较少参与可能增加 CMV 传播风险的活动。数字干预措施受到孕妇的高度认可。总的来说，在研究过程中有 4 名参与者发生血清转化：两组各有 2 名。
在英国，进行一项针对 CMV 数字干预措施疗效的大型多中心 RCT 是可行的；本研究产生了有力的研究数据。这项单中心可行性 RCT 表明，数字教育干预措施与 CMV 知识的增加有关，并可能导致行为改变，从而降低妊娠期间 CMV 感染的风险。
Clinicaltrials.gov，NCT03511274，注册于 2018 年 4 月 27 日，网址：http://www.Clinicaltrials.gov。
