Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA 19104, USA.
Hum Reprod. 2014 Mar;29(3):441-7. doi: 10.1093/humrep/det450. Epub 2013 Dec 18.
Are there improvements in the accuracy of prediction of ectopic pregnancy (EP) in women with early symptomatic pregnancy using human chorionic gonadotrophin (hCG) curves when clinicians consider visits beyond the first 48 h after initial presentation?
Two hCG values, measured 48 h (2 days) apart, are often not sufficient to accurately predict the outcome of a woman with a pregnancy of unknown location (PUL), but adding a third visit on Day 4 or 7 significantly improved the prediction for 1 in 15 women.
The use of serial hCG values is commonly used to aid in the prediction of the final diagnosis in women with a PUL. Initial outcome predictions based on two hCG values may often be incorrect.
STUDY DESIGN, SIZE, DURATION: This retrospective multicenter cohort study included 646 women with a PUL, recruited over 2 years. Of these women, 146 were ultimately diagnosed with EP.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Women presenting to the emergency room with first trimester pain or bleeding, with a PUL, at least 2 hCG values and a definitive final diagnosis from the University of Pennsylvania, University of Miami and University of Southern California, were recruited from 2007 to 2009.
Using currently recommended prediction rules, adding a third hCG evaluation on Day 4 after initial presentation significantly improved the accuracy of initial prediction from the first two values (48 h apart, or Day 2) by 9.3% (P = 0.015). Adding a third value on Day 7 improved prediction significantly by 6.7% (P = 0.031), compared with prediction based on first two values. The improvement in prediction by assessing four hCG values (Days 0, 2, 4 and 7) compared with three values (Days 0, 2 and 4) was 1.3% and not statistically significant.
LIMITATIONS, REASONS FOR CAUTION: Missing data imputation likely biased results toward the null; predicted outcomes may not match those made by clinicians; and the study does not predict intrauterine pregnancy and spontaneous miscarriage separately.
This study provides useful information for the prediction of outcomes for women with a symptomatic first trimester pregnancy of unknown location, but may not be generalizable to all pregnant women.
STUDY FUNDING/COMPETING INTEREST(S): Supported by NIH grant numbers R01-HD036455 to Dr Barnhart and Dr Sammel, K24HD060687 to Dr Barnhart, and 5T32MH065218 to Ms. Zee. The authors have no conflicts of interest to declare.
对于首次就诊后 48 小时后就诊的有早期症状妊娠的女性,使用人绒毛膜促性腺激素(hCG)曲线是否可以提高异位妊娠(EP)预测的准确性?
两次 hCG 值,相隔 48 小时(2 天)测量,通常不足以准确预测妊娠位置不明(PUL)女性的结局,但在第 4 天或第 7 天增加第三次就诊,可显著提高 15 分之一女性的预测准确性。
使用连续 hCG 值通常用于辅助预测有 PUL 的女性的最终诊断。基于两次 hCG 值的初始结局预测可能经常不准确。
研究设计、大小、持续时间:这项回顾性多中心队列研究纳入了 646 名有 PUL 的女性,在 2 年内招募。这些女性中,最终有 146 名被诊断为 EP。
参与者/材料、地点、方法:2007 年至 2009 年,从宾夕法尼亚大学、迈阿密大学和南加州大学招募了因妊娠位置不明在急诊室就诊,有至少两次 hCG 值和明确的最终诊断的早期妊娠腹痛或出血的女性。
使用目前推荐的预测规则,在首次就诊后第 4 天增加第三次 hCG 评估,可将初始预测的准确性从第一次就诊后 48 小时(即第 2 天)提高 9.3%(P = 0.015)。在第 7 天增加第三次值可显著提高预测准确性 6.7%(P = 0.031),与基于前两次值的预测相比。与评估四次 hCG 值(第 0、2、4 和 7 天)相比,评估三次 hCG 值(第 0、2 和 4 天)的预测仅提高了 1.3%,无统计学意义。
局限性、谨慎的原因:缺失数据插补可能使结果偏向于零;预测结果可能与临床医生的判断不符;该研究不能分别预测宫内妊娠和自然流产。
这项研究为有症状的早期妊娠位置不明的女性的结局预测提供了有用的信息,但可能不适用于所有孕妇。
研究资助/利益冲突:本研究由 NIH 资助,R01-HD036455 资助给 Barnhart 博士和 Sammel 博士,K24HD060687 资助给 Barnhart 博士,5T32MH065218 资助给 Zee 女士。作者无利益冲突声明。