羊膜穿刺术诊断母体原发性感染后先天性巨细胞病毒感染。
Amniocentesis to diagnose congenital cytomegalovirus infection following maternal primary infection.
机构信息
Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL (Dr Dinsmoor and Ms Mallett).
The George Washington University Biostatistics Center, Washington, DC (Drs Fette and Thom).
出版信息
Am J Obstet Gynecol MFM. 2022 Jul;4(4):100641. doi: 10.1016/j.ajogmf.2022.100641. Epub 2022 May 6.
BACKGROUND
Congenital cytomegalovirus infection following maternal primary cytomegalovirus infection affects approximately 0.4% of newborns in the United States but may be hard to diagnose prenatally.
OBJECTIVE
To evaluate the current sensitivity and specificity of amniocentesis in detecting congenital cytomegalovirus infection.
STUDY DESIGN
Secondary analysis of a multicenter randomized placebo-controlled trial designed to evaluate whether cytomegalovirus hyperimmune globulin reduces congenital cytomegalovirus infection in neonates of individuals diagnosed with primary cytomegalovirus infection before 24 weeks of gestation. At randomization, subjects had no clinical evidence of fetal infection. Eligible subjects were randomized to monthly infusions of cytomegalovirus hyperimmune globulin or placebo until delivery. Although not required by the trial protocol, amniocentesis following randomization was permitted. The fetuses and neonates were tested for the presence of cytomegalovirus at delivery. Comparisons were made between those with and without amniocentesis and between those with cytomegalovirus-positive and negative results, using chi-square or Fisher exact test for categorical variables and the Wilcoxon rank sum test or t test for continuous variables. A P value of <.05 was considered significant.
RESULTS
From 2012 to 2018, 397 subjects were included, of whom 55 (14%) underwent amniocentesis. Cytomegalovirus results were available for 53 fetuses and neonates. Fourteen amniocenteses were positive (25%). Gestational age at amniocentesis was similar between those with and without cytomegalovirus present, as was the interval between maternal diagnosis and amniocentesis. The prevalence of fetal or neonatal infection was 26% (14/53). The neonates of all 12 subjects with a positive amniocentesis and available results had cytomegalovirus infection confirmed at delivery, as did 2 neonates from the group of 41 subjects with a negative amniocentesis, with a sensitivity of 86% (95% confidence interval, 57-98), specificity of 100% (95% confidence interval, 91-100), positive predictive value of 100% (95% confidence interval, 74-100), and negative predictive value of 95% (95% confidence interval, 83-99). Amniocentesis-positive pregnancies were delivered at an earlier gestational age (37.4 vs 39.6 weeks; P<.001) and had lower birthweights (2583±749 vs 3428±608 g, P=.004) than amniocentesis-negative pregnancies.
CONCLUSION
Amniocentesis results are an accurate predictor of congenital cytomegalovirus infection.
背景
在美国，大约有 0.4%的新生儿会受到母体原发性巨细胞病毒感染后先天性巨细胞病毒感染的影响，但这种感染可能难以在产前诊断。
目的
评估羊膜穿刺术在检测先天性巨细胞病毒感染方面的当前敏感性和特异性。
研究设计
对一项多中心随机安慰剂对照试验进行二次分析，该试验旨在评估巨细胞病毒免疫球蛋白是否能降低在妊娠 24 周前被诊断为原发性巨细胞病毒感染的个体的新生儿先天性巨细胞病毒感染。在随机分组时，受试者没有胎儿感染的临床证据。符合条件的受试者被随机分配到每月接受巨细胞病毒免疫球蛋白或安慰剂输注，直到分娩。尽管试验方案没有要求，但允许在随机分组后进行羊膜穿刺术。在分娩时对胎儿和新生儿进行巨细胞病毒检测。使用卡方检验或 Fisher 确切概率法比较有无羊膜穿刺术的情况，使用 Wilcoxon 秩和检验或 t 检验比较巨细胞病毒阳性和阴性结果，P 值<.05 认为差异有统计学意义。
结果
2012 年至 2018 年，共纳入 397 名受试者，其中 55 名（14%）进行了羊膜穿刺术。53 名胎儿和新生儿的巨细胞病毒检测结果可用。14 次羊膜穿刺术呈阳性（25%）。行羊膜穿刺术时的胎龄在有巨细胞病毒和无巨细胞病毒的情况下相似，母体诊断与羊膜穿刺术之间的间隔时间也相似。胎儿或新生儿感染的患病率为 26%（14/53）。12 名羊膜穿刺术阳性且结果可用的受试者的新生儿均在分娩时证实有巨细胞病毒感染，41 名羊膜穿刺术阴性且结果可用的受试者中有 2 名新生儿也证实有巨细胞病毒感染，敏感性为 86%（95%置信区间，57-98），特异性为 100%（95%置信区间，91-100），阳性预测值为 100%（95%置信区间，74-100），阴性预测值为 95%（95%置信区间，83-99）。羊膜穿刺术阳性的妊娠分娩胎龄更早（37.4 周 vs 39.6 周；P<.001），出生体重更低（2583±749 克 vs 3428±608 克，P=.004）。
结论
羊膜穿刺术结果是先天性巨细胞病毒感染的准确预测指标。
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