AimIn Japan, noninvasive prenatal testing (NIPT) has been performed by facilities accredited by the Japanese Society of Obstetrics and Gynecology since 2013. However, since 2016, with the implementation of NIPT, which can only be performed by blood sampling, non‐obstetricians have been involved in prenatal testing. Therefore, in July 2022, a new government‐involved NIPT certification system based on Health Sciences Council guidelines was introduced to ensure access to prenatal testing information for pregnant women.MethodsThis survey was conducted in February 2023 and was the first survey after the certification system implementation. We conducted a web‐based survey of 1227 pregnant women and nursing mothers who underwent NIPT after July 2022 to evaluate their experiences.ResultsRespondents were categorized by certification status as certified (C: 56%), non‐certified (non‐C: 23%), or uncertain (Q: 20%). The C group with a higher mean age at examination (35.0 ± 4.5 years) paid lower examination fees, received longer pre‐ and post‐examination explanations, and underwent more weekday examinations (80%) than the other groups. Most respondents, 67%, 48%, and 53% in the C, non‐C, and Q groups, respectively (p < 0.0001), stated that “NIPT needs to be regulated by the government or academic societies.” The non‐C group was more likely to say, “Insufficient post‐test explanations at the laboratory made me more anxious,” than the other groups when the testing results were non‐negative (p = 0.015).ConclusionsDespite government regulation, some pregnant women choose convenience over certified facilities, risking inadequate care. The government should ensure that NIPT is a safe option for all pregnant women.

中文翻译：

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政府参与的新无创产前检查认证制度对日本孕妇无创产前检查意识的影响


Aim在日本，自 2013 年以来，无创产前检查 （NIPT） 一直由日本妇产科学会认可的机构进行。然而，自 2016 年以来，随着只能通过血液采样进行的 NIPT 的实施，非产科医生开始参与产前检查。因此，在 2022 年 7 月，基于健康科学委员会指南引入了一个新的政府参与的 NIPT 认证系统，以确保孕妇能够获得产前检测信息。方法本次调查于 2023 年 2 月进行，是认证系统实施后的首次调查。我们对 2022 年 7 月之后接受 NIPT 的 1227 名孕妇和哺乳期母亲进行了一项基于网络的调查，以评估她们的经历。结果受访者按认证状态分为认证 （C： 56%）、未认证 （non-C： 23%） 或不确定 （Q： 20%）。与其他组相比，平均检查年龄较高的 C 组 （35.0 ± 4.5 岁） 支付的检查费用较低，检查前和检查后的解释时间更长，并且接受的工作日检查次数更多 （80%）。C组、非C组和Q组的大多数受访者分别为67%、48%和53%（p < 0.0001）表示“NIPT需要由政府或学术团体监管”。当测试结果为非阴性时，非 C 组比其他组更有可能说，“实验室的检测后解释不足使我更加焦虑”（p = 0.015）。结论尽管政府有监管，但一些孕妇选择便利而不是经过认证的设施，冒着护理不足的风险。政府应确保 NIPT 对所有孕妇来说都是一个安全的选择。