Abstract：
OBJECTIVE: To evaluate the safety of current guidelines on methotrexate (MTX) administration in women with pregnancy of unknown location (PUL) who are considered to have a high risk of underlying ectopic pregnancy (EP), and to investigate whether implementation of these guidelines would result in inadvertent exposure to MTX of viable intrauterine pregnancies (IUPs).
METHODS: This was a retrospective observational study of consecutive clinically stable women who were classified with PUL at the early pregnancy unit of Nepean Hospital, Sydney, Australia, between 2007 and 2021. PUL was defined as a positive pregnancy test in the absence of signs of IUP or EP on transvaginal ultrasound. Patients with a PUL that behaved biochemically like an EP, but for which the location of pregnancy was not confirmed on ultrasound, were eligible for MTX to minimize the risk of subsequent tubal rupture. Criteria discussed in the guidelines of the American College of Obstetricians and Gynecologists (ACOG), American Society for Reproductive Medicine (ASRM), Royal College of Obstetricians and Gynaecologists (RCOG) and National Institute for Health and Care Excellence (NICE) were applied to the PUL database. The number of patients eligible to receive MTX and the number with an underlying viable IUP who would be inadvertently prescribed MTX were calculated.
RESULTS: A total of 816 women with PUL were reviewed, of whom 724 had complete data and were included in the final analysis. Six patients had persistent PUL and the remaining 718 had a diagnosis of viable IUP, non-viable IUP, EP or failed PUL. According to the ACOG, ASRM, RCOG and NICE guidelines, the rate of MTX administration among patients with PUL would have been 2.76%, 4.56%, 0.41% and 35.36%, respectively. However, no persistent PUL would have received MTX according to the ACOG, ASRM and RCOG protocols (the NICE protocol identified patients with persistent PUL with a sensitivity of 100%), and the majority of MTX treatments were unnecessary because those patients were later classified as having non-viable IUP or failed PUL. Application of ACOG and ASRM guidance could result theoretically in inadvertent MTX administration to women with an underlying viable IUP at a rate of 4.1/1000 (3/724).
CONCLUSIONS: Current guidelines used to predict high risk of EP in the PUL population lead to inadvertent MTX administration to women with an underlying viable IUP. These guidelines should be used wisely to ensure that no wanted pregnancy is exposed to MTX. Women with PUL should be monitored carefully, and MTX should be used judiciously when the location of pregnancy is yet to be confirmed. © 2024 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
METHODS: This was a retrospective observational study of consecutive clinically stable women who were classified with PUL at the early pregnancy unit of Nepean Hospital, Sydney, Australia, between 2007 and 2021. PUL was defined as a positive pregnancy test in the absence of signs of IUP or EP on transvaginal ultrasound. Patients with a PUL that behaved biochemically like an EP, but for which the location of pregnancy was not confirmed on ultrasound, were eligible for MTX to minimize the risk of subsequent tubal rupture. Criteria discussed in the guidelines of the American College of Obstetricians and Gynecologists (ACOG), American Society for Reproductive Medicine (ASRM), Royal College of Obstetricians and Gynaecologists (RCOG) and National Institute for Health and Care Excellence (NICE) were applied to the PUL database. The number of patients eligible to receive MTX and the number with an underlying viable IUP who would be inadvertently prescribed MTX were calculated.
RESULTS: A total of 816 women with PUL were reviewed, of whom 724 had complete data and were included in the final analysis. Six patients had persistent PUL and the remaining 718 had a diagnosis of viable IUP, non-viable IUP, EP or failed PUL. According to the ACOG, ASRM, RCOG and NICE guidelines, the rate of MTX administration among patients with PUL would have been 2.76%, 4.56%, 0.41% and 35.36%, respectively. However, no persistent PUL would have received MTX according to the ACOG, ASRM and RCOG protocols (the NICE protocol identified patients with persistent PUL with a sensitivity of 100%), and the majority of MTX treatments were unnecessary because those patients were later classified as having non-viable IUP or failed PUL. Application of ACOG and ASRM guidance could result theoretically in inadvertent MTX administration to women with an underlying viable IUP at a rate of 4.1/1000 (3/724).
CONCLUSIONS: Current guidelines used to predict high risk of EP in the PUL population lead to inadvertent MTX administration to women with an underlying viable IUP. These guidelines should be used wisely to ensure that no wanted pregnancy is exposed to MTX. Women with PUL should be monitored carefully, and MTX should be used judiciously when the location of pregnancy is yet to be confirmed. © 2024 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
摘要：
目的：为了评估当前指南对不明部位妊娠（PUL）且被认为具有潜在异位妊娠（EP）高风险的女性使用甲氨蝶呤（MTX）的安全性，并调查这些指南的实施是否会导致可行的宫内妊娠（IUP）无意中暴露于MTX。
方法：这是一项回顾性观察性研究，对在Nepean医院妊娠早期病房接受PUL分类的连续临床稳定妇女，悉尼,澳大利亚,2007年至2021年。PUL被定义为在经阴道超声检查中没有IUP或EP迹象的情况下妊娠试验阳性。具有类似于EP的生化行为的PUL患者，但是在超声波上没有确认怀孕的位置，有资格使用MTX，以最大程度地减少随后输卵管破裂的风险。美国妇产科医师学会（ACOG）指南中讨论的标准，美国生殖医学学会（ASRM），皇家妇产科学院（RCOG）和国家健康与护理卓越研究所（NICE）被应用于PUL数据库。计算了有资格接受MTX的患者数量和可能无意中开出MTX处方的潜在可行IUP的数量。
结果：共对816名患有PUL的女性进行了回顾，其中724人拥有完整的数据，并被纳入最终分析。6例患者患有持续性PUL，其余718例诊断为可行的IUP，不可行的IUP，EP或失败的PUL。根据ACOG，ASRM,RCOG和NICE指南，在患有PUL的患者中，MTX的使用率为2.76%，4.56%,0.41%和35.36%，分别。然而,根据ACOG，没有持久性PUL会收到MTX，ASRM和RCOG方案（NICE方案以100%的灵敏度识别持续性PUL患者），大多数MTX治疗是不必要的,因为这些患者后来被分类为IUP无活性或PUL失败.ACOG和ASRM指导的应用在理论上可能导致以4.1/1000(3/724)的比率对具有潜在可行IUP的女性意外施用MTX。
结论：目前用于预测PUL人群中EP风险高的指南会导致对具有潜在可行IUP的女性不小心给予MTX。应明智地使用这些指南，以确保没有想要的怀孕暴露于MTX。患有PUL的女性应该仔细监测，当怀孕的位置尚未确认时，应谨慎使用MTX。©2024作者由JohnWiley&SonsLtd代表国际妇产科超声学会出版的妇产科超声。
方法：这是一项回顾性观察性研究，对在Nepean医院妊娠早期病房接受PUL分类的连续临床稳定妇女，悉尼,澳大利亚,2007年至2021年。PUL被定义为在经阴道超声检查中没有IUP或EP迹象的情况下妊娠试验阳性。具有类似于EP的生化行为的PUL患者，但是在超声波上没有确认怀孕的位置，有资格使用MTX，以最大程度地减少随后输卵管破裂的风险。美国妇产科医师学会（ACOG）指南中讨论的标准，美国生殖医学学会（ASRM），皇家妇产科学院（RCOG）和国家健康与护理卓越研究所（NICE）被应用于PUL数据库。计算了有资格接受MTX的患者数量和可能无意中开出MTX处方的潜在可行IUP的数量。
结果：共对816名患有PUL的女性进行了回顾，其中724人拥有完整的数据，并被纳入最终分析。6例患者患有持续性PUL，其余718例诊断为可行的IUP，不可行的IUP，EP或失败的PUL。根据ACOG，ASRM,RCOG和NICE指南，在患有PUL的患者中，MTX的使用率为2.76%，4.56%,0.41%和35.36%，分别。然而,根据ACOG，没有持久性PUL会收到MTX，ASRM和RCOG方案（NICE方案以100%的灵敏度识别持续性PUL患者），大多数MTX治疗是不必要的,因为这些患者后来被分类为IUP无活性或PUL失败.ACOG和ASRM指导的应用在理论上可能导致以4.1/1000(3/724)的比率对具有潜在可行IUP的女性意外施用MTX。
结论：目前用于预测PUL人群中EP风险高的指南会导致对具有潜在可行IUP的女性不小心给予MTX。应明智地使用这些指南，以确保没有想要的怀孕暴露于MTX。患有PUL的女性应该仔细监测，当怀孕的位置尚未确认时，应谨慎使用MTX。©2024作者由JohnWiley&SonsLtd代表国际妇产科超声学会出版的妇产科超声。
