Kassie J. Bollig, Alex Finlinson, Kurt T. Barnhart, Christos Coutifaris, Danny J. Schust
{"title":"未知生存能力妊娠中人绒毛膜促性腺激素升高新模型的评价","authors":"Kassie J. Bollig, Alex Finlinson, Kurt T. Barnhart, Christos Coutifaris, Danny J. Schust","doi":"10.1097/01.ogx.0000993688.03052.e5","DOIUrl":null,"url":null,"abstract":"Abstract For early pregnancy management, quantitative serum human chorionic gonadotropin (hCG) measurements and transvaginal ultrasonography are the standard clinical guides. Current guidelines use the change in hCG levels to determine likely location of the pregnancy but represent a minimal rate to predict viability. When incorrectly used, these are inaccurate. This study examined the performance of a new hCG threshold model and compared it with 3 established models. The study is a retrospective cohort study. All individuals with at least 2 consecutive quantitative hCG serum levels seen at the University of Missouri–Columbia from January 1, 2015, until March 1, 2020, were screened for study eligibility. Eligibility requirements were 3-fold: first, patients who presented with pregnancy of unknown viability; second, they had an initial hCG level between 2 and 5000 mIU/mL, maintaining the first interval of no greater than 7 days between testing; and third, the final pregnancy outcome was confirmed. Exclusion occurred for patients who had germ cell tumors, had molar pregnancies, had an intrauterine device in place, utilized hCG monitoring for a molar pregnancy or elective abortion, utilized assisted reproductive technology to achieve pregnancy, or were lost to follow-up. Results of the study came from a pool of 688 patients who met all the inclusion criteria. They contributed an average of 2.3 measurements per patient for a total of 1554 hCG measurements. There was an average of 10.1 days for follow-up. Of those patients included, 167 had viable intrauterine pregnancy (IUP) (24.3%), 463 experienced early pregnancy loss (67.3%), and 58 had ectopic pregnancies (8.4%). The rates of rise in values up to 4 days and again between 4 and 6 days were added for a total rate or rise. Because this was a retrospective study, a calculation was used when hCG levels were not available on day 4 or 6. The values were calculated to be conservative and to avoid incorrectly classifying any viable pregnancy as nonviable. Strengths of the study include its large sample size, its inclusion of all 3 pregnancy outcomes, verified pregnancy outcomes, and subsequent misclassification assessments based off of the aforementioned strength. This study confirmed 122 of 168 viable IUPs (72.6%) had live births, and the simple nature of the study allows for easy integration into clinical practice. Finally, the new model allows for greater variation in days on which a patient must present for care. Study limitations included imputed values from hCG samples not specifically collected on day 4 or 6. Despite this, application of the proposed model utilizing merely known values resulted in better performance. In addition, minimal rise for hCG rates in this data set may be a result of internal validation that may differ in larger, multi-institutional data sets. Furthermore, it must be remembered that current methods using hCG thresholds to determine pregnancy viability rely predominantly on mathematical data analysis and thereby do not reach 100% accuracy thresholds due to biologic variations. Based on this reason, hCG rises below cutoffs established should not mandate a reflexive nonviability diagnosis. The study concluded that although shared decision-making remains paramount in determining management steps, the proposed new model simultaneously reduced unnecessary interventions and optimized correct classification rates for all subgroups of pregnancy. Further prospective studies and investigations of cost-effectiveness are needed before widespread model implementation for pregnancy classification.","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":4.3000,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluation of a New Model for Human Chorionic Gonadotropin Rise in Pregnancies of Unknown Viability\",\"authors\":\"Kassie J. Bollig, Alex Finlinson, Kurt T. Barnhart, Christos Coutifaris, Danny J. Schust\",\"doi\":\"10.1097/01.ogx.0000993688.03052.e5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Abstract For early pregnancy management, quantitative serum human chorionic gonadotropin (hCG) measurements and transvaginal ultrasonography are the standard clinical guides. Current guidelines use the change in hCG levels to determine likely location of the pregnancy but represent a minimal rate to predict viability. When incorrectly used, these are inaccurate. This study examined the performance of a new hCG threshold model and compared it with 3 established models. The study is a retrospective cohort study. All individuals with at least 2 consecutive quantitative hCG serum levels seen at the University of Missouri–Columbia from January 1, 2015, until March 1, 2020, were screened for study eligibility. Eligibility requirements were 3-fold: first, patients who presented with pregnancy of unknown viability; second, they had an initial hCG level between 2 and 5000 mIU/mL, maintaining the first interval of no greater than 7 days between testing; and third, the final pregnancy outcome was confirmed. Exclusion occurred for patients who had germ cell tumors, had molar pregnancies, had an intrauterine device in place, utilized hCG monitoring for a molar pregnancy or elective abortion, utilized assisted reproductive technology to achieve pregnancy, or were lost to follow-up. Results of the study came from a pool of 688 patients who met all the inclusion criteria. They contributed an average of 2.3 measurements per patient for a total of 1554 hCG measurements. There was an average of 10.1 days for follow-up. Of those patients included, 167 had viable intrauterine pregnancy (IUP) (24.3%), 463 experienced early pregnancy loss (67.3%), and 58 had ectopic pregnancies (8.4%). The rates of rise in values up to 4 days and again between 4 and 6 days were added for a total rate or rise. Because this was a retrospective study, a calculation was used when hCG levels were not available on day 4 or 6. The values were calculated to be conservative and to avoid incorrectly classifying any viable pregnancy as nonviable. Strengths of the study include its large sample size, its inclusion of all 3 pregnancy outcomes, verified pregnancy outcomes, and subsequent misclassification assessments based off of the aforementioned strength. This study confirmed 122 of 168 viable IUPs (72.6%) had live births, and the simple nature of the study allows for easy integration into clinical practice. Finally, the new model allows for greater variation in days on which a patient must present for care. Study limitations included imputed values from hCG samples not specifically collected on day 4 or 6. Despite this, application of the proposed model utilizing merely known values resulted in better performance. In addition, minimal rise for hCG rates in this data set may be a result of internal validation that may differ in larger, multi-institutional data sets. Furthermore, it must be remembered that current methods using hCG thresholds to determine pregnancy viability rely predominantly on mathematical data analysis and thereby do not reach 100% accuracy thresholds due to biologic variations. Based on this reason, hCG rises below cutoffs established should not mandate a reflexive nonviability diagnosis. The study concluded that although shared decision-making remains paramount in determining management steps, the proposed new model simultaneously reduced unnecessary interventions and optimized correct classification rates for all subgroups of pregnancy. Further prospective studies and investigations of cost-effectiveness are needed before widespread model implementation for pregnancy classification.\",\"PeriodicalId\":19409,\"journal\":{\"name\":\"Obstetrical & Gynecological Survey\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2023-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Obstetrical & Gynecological Survey\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1097/01.ogx.0000993688.03052.e5\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Obstetrical & Gynecological Survey","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1097/01.ogx.0000993688.03052.e5","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
血清人绒毛膜促性腺激素(hCG)定量测定和经阴道超声检查是早期妊娠管理的标准临床指导。目前的指导方针使用hCG水平的变化来确定可能的怀孕位置,但代表了预测生存能力的最低比率。如果使用不当,这些都是不准确的。本研究检验了一种新的hCG阈值模型的性能,并将其与3种已建立的模型进行了比较。本研究为回顾性队列研究。2015年1月1日至2020年3月1日期间在密苏里-哥伦比亚大学(University of Missouri-Columbia)至少连续两次出现hCG定量血清水平的所有个体均被筛选为研究资格。资格要求有3个方面:第一,出现生存能力未知的妊娠的患者;第二,他们的初始hCG水平在2 - 5000 mIU/mL之间,第一次测试间隔不超过7天;第三,最终妊娠结局得到确认。排除有生殖细胞肿瘤、有磨牙妊娠、有宫内节育器、使用hCG监测磨牙妊娠或选择性流产、使用辅助生殖技术实现妊娠或失去随访的患者。该研究的结果来自688名符合所有纳入标准的患者。在1554次hCG测量中,他们平均为每位患者贡献了2.3次测量。随访时间平均为10.1天。在这些患者中,167例有宫内妊娠(IUP)(24.3%), 463例早期妊娠丢失(67.3%),58例异位妊娠(8.4%)。4天内和4至6天内的价值增长率相加,得到总增长率或增长率。因为这是一项回顾性研究,所以当第4天或第6天hCG水平无法获得时,使用了计算方法。这些数值的计算是保守的,并避免将任何可存活的妊娠错误地归类为不可存活的妊娠。该研究的优势包括样本量大,包括所有三种妊娠结局,验证妊娠结局,以及基于上述优势的后续错误分类评估。本研究证实168例可行的IUPs中有122例(72.6%)有活产,并且该研究的简单性使其易于整合到临床实践中。最后,新模式允许病人必须来看病的天数有更大的变化。研究的局限性包括未在第4天或第6天特异性收集的hCG样本的估算值。尽管如此,应用仅利用已知值的所提出的模型可以获得更好的性能。此外,该数据集中hCG率的微小上升可能是内部验证的结果,这在更大的多机构数据集中可能有所不同。此外,必须记住,目前使用hCG阈值来确定妊娠存活率的方法主要依赖于数学数据分析,因此由于生物变异,无法达到100%的准确性阈值。基于这个原因,hCG上升低于临界值不应该强制要求一个反射性的无生存能力的诊断。该研究得出结论,尽管共同决策在确定管理步骤方面仍然至关重要,但提出的新模型同时减少了不必要的干预,并优化了所有妊娠亚组的正确分类率。在广泛应用妊娠分类模型之前,需要进一步的前瞻性研究和成本效益调查。
Evaluation of a New Model for Human Chorionic Gonadotropin Rise in Pregnancies of Unknown Viability
Abstract For early pregnancy management, quantitative serum human chorionic gonadotropin (hCG) measurements and transvaginal ultrasonography are the standard clinical guides. Current guidelines use the change in hCG levels to determine likely location of the pregnancy but represent a minimal rate to predict viability. When incorrectly used, these are inaccurate. This study examined the performance of a new hCG threshold model and compared it with 3 established models. The study is a retrospective cohort study. All individuals with at least 2 consecutive quantitative hCG serum levels seen at the University of Missouri–Columbia from January 1, 2015, until March 1, 2020, were screened for study eligibility. Eligibility requirements were 3-fold: first, patients who presented with pregnancy of unknown viability; second, they had an initial hCG level between 2 and 5000 mIU/mL, maintaining the first interval of no greater than 7 days between testing; and third, the final pregnancy outcome was confirmed. Exclusion occurred for patients who had germ cell tumors, had molar pregnancies, had an intrauterine device in place, utilized hCG monitoring for a molar pregnancy or elective abortion, utilized assisted reproductive technology to achieve pregnancy, or were lost to follow-up. Results of the study came from a pool of 688 patients who met all the inclusion criteria. They contributed an average of 2.3 measurements per patient for a total of 1554 hCG measurements. There was an average of 10.1 days for follow-up. Of those patients included, 167 had viable intrauterine pregnancy (IUP) (24.3%), 463 experienced early pregnancy loss (67.3%), and 58 had ectopic pregnancies (8.4%). The rates of rise in values up to 4 days and again between 4 and 6 days were added for a total rate or rise. Because this was a retrospective study, a calculation was used when hCG levels were not available on day 4 or 6. The values were calculated to be conservative and to avoid incorrectly classifying any viable pregnancy as nonviable. Strengths of the study include its large sample size, its inclusion of all 3 pregnancy outcomes, verified pregnancy outcomes, and subsequent misclassification assessments based off of the aforementioned strength. This study confirmed 122 of 168 viable IUPs (72.6%) had live births, and the simple nature of the study allows for easy integration into clinical practice. Finally, the new model allows for greater variation in days on which a patient must present for care. Study limitations included imputed values from hCG samples not specifically collected on day 4 or 6. Despite this, application of the proposed model utilizing merely known values resulted in better performance. In addition, minimal rise for hCG rates in this data set may be a result of internal validation that may differ in larger, multi-institutional data sets. Furthermore, it must be remembered that current methods using hCG thresholds to determine pregnancy viability rely predominantly on mathematical data analysis and thereby do not reach 100% accuracy thresholds due to biologic variations. Based on this reason, hCG rises below cutoffs established should not mandate a reflexive nonviability diagnosis. The study concluded that although shared decision-making remains paramount in determining management steps, the proposed new model simultaneously reduced unnecessary interventions and optimized correct classification rates for all subgroups of pregnancy. Further prospective studies and investigations of cost-effectiveness are needed before widespread model implementation for pregnancy classification.
期刊介绍:
Each monthly issue of Obstetrical & Gynecological Survey presents summaries of the most timely and clinically relevant research being published worldwide. These concise, easy-to-read summaries provide expert insight into how to apply the latest research to patient care. The accompanying editorial commentary puts the studies into perspective and supplies authoritative guidance. The result is a valuable, time-saving resource for busy clinicians.