From Gynuity Health Projects, New York, New York; Planned Parenthood of New York City, Inc., New York, New York; Planned Parenthood of San Diego and Riverside Counties, San Diego, California; and Family Planning Associates Medical Group, Chicago, Illinois.
Obstet Gynecol. 2010 Feb;115(2 Pt 1):264-272. doi: 10.1097/AOG.0b013e3181c996f3.
To evaluate the ability of women and their providers to assess abortion outcome without the routine use of ultrasonography.
This multicenter trial enrolled 4,484 women seeking medical abortion at 10 clinics in the United States. Women received the standard medical abortion care with mifepristone-misoprostol in those clinics and blinded clinical assessments before follow-up ultrasonography. Data were collected prospectively on abortion outcomes, receipt of additional treatment, and clinical, laboratory, and ultrasound assessments associated with the procedure. We constructed five model algorithms for evaluating women's postabortion status, each using a different assortment of data. Four of the algorithms (algorithms 1-4) rely on data collected by the woman and on the results of the low-sensitivity pregnancy test. Algorithm 5 relies on the woman's assessment, the results of the pregnancy test, and follow-up physician assessment (sometimes including bimanual or speculum examination).
A total of 3,054 women received medical abortion and had adequate data for evaluation. Twenty women (0.7%) had an ongoing pregnancy; 26 (0.9%) received curettage for retained tissue, empiric treatment for possible infection, or both; and 55 (1.8%) received additional uterotonics or other medical abortion-related care. Screening algorithms including patient-observed outcomes, a low-sensitivity pregnancy test, and nonsonographic clinical evaluation were as effective as sonography in identifying women who received interventions at or after the follow-up visit.
Relying on women's observations, a low-sensitivity pregnancy test, and clinical examination, women and their providers can accurately assess whether follow-up care is required after medical abortion without routine ultrasonography.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00120224.
II.
评估女性及其提供者在不常规使用超声检查的情况下评估流产结局的能力。
这项多中心试验纳入了在美国 10 家诊所寻求药物流产的 4484 名女性。这些诊所为女性提供米非司酮-米索前列醇标准药物流产护理，并在后续超声检查前进行盲法临床评估。前瞻性收集流产结局、额外治疗以及与手术相关的临床、实验室和超声评估的数据。我们构建了五个评估女性流产后状态的模型算法，每个算法都使用不同的数据组合。前四个算法（算法 1-4）依赖于女性收集的数据以及低灵敏度妊娠试验的结果。算法 5依赖于女性的评估、妊娠试验的结果以及后续医生的评估（有时包括双合诊或窥器检查）。
共有 3054 名女性接受了药物流产，并获得了足够的评估数据。20 名女性（0.7%）妊娠继续；26 名女性（0.9%）因残留组织接受了刮宫术、经验性治疗可能的感染或两者兼有；55 名女性（1.8%）接受了额外的宫缩剂或其他与药物流产相关的治疗。包括患者观察到的结果、低灵敏度妊娠试验和非超声临床评估在内的筛查算法与超声检查一样，能准确识别在随访就诊时或之后需要干预的女性。
依靠女性的观察、低灵敏度妊娠试验和临床检查，女性及其提供者可以在不常规进行超声检查的情况下准确评估药物流产后是否需要随访护理。
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00120224。
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