University College Hospital, Gynaecology Diagnostic and Outpatient Treatment Unit, London, UK.
Ultrasound Obstet Gynecol. 2013 Jul;42(1):102-7. doi: 10.1002/uog.12401. Epub 2013 May 27.
To validate the efficacy and safety of our clinical protocol for expectant management of selected women diagnosed with tubal ectopic pregnancy.
This was a prospective observational study carried out in the early pregnancy unit of a London inner-city university teaching hospital from 1(st) January 2008 to 31(st) May 2011. All women presenting with suspected early pregnancy complications were assessed clinically and by transvaginal ultrasound. Those with a conclusive ultrasound diagnosis of tubal ectopic pregnancy were selected for either surgical or expectant management. Selection criteria for expectant management were clinical stability with no or minimal abdominal pain, no evidence of significant hemoperitoneum on ultrasound scan, ectopic pregnancy measuring < 30 mm in mean diameter with no evidence of embryonic cardiac activity, serum β-human chorionic gonadotropin (β-hCG) < 1500 IU/L and the woman's consent. All women selected for expectant management were followed up as outpatients until the ectopic pregnancy regressed spontaneously (resolution of clinical symptoms, serum β-hCG < 20 IU/L/negative urine pregnancy test) or surgical intervention was required. We recorded the rate of interventions, complications and length of follow-up.
During the study period 339/11 520 (2.9% (95% CI, 2.59-3.21%)) women were diagnosed with tubal ectopic pregnancy. Six women opted to participate in an ongoing randomized controlled trial and were excluded from further analysis. One hundred and sixty-five (49.5% (95% CI, 44.2-55.0%)) of the 333 remaining women met the criteria for expectant management; 146/333 (43.8% (95% CI, 38.5-49.1%)) of them opted for expectant management and 104/333 (31.2% (95% CI, 26.2-36.2%)) of all tubal ectopics resolved without requiring any intervention. All women with failed expectant management were treated by laparoscopic salpingectomy/salpingotomy and none of them required a blood transfusion.
Our clinical protocol for expectant management of tubal ectopic pregnancies eliminates the need for medical or surgical treatment in more than a third of women diagnosed with tubal ectopic pregnancy with a minimum risk of adverse outcome.
验证我们对选定的诊断为输卵管异位妊娠的妇女进行期待治疗的临床方案的疗效和安全性。
这是一项前瞻性观察研究,于 2008 年 1 月 1 日至 2011 年 5 月 31 日在伦敦市中心一所大学教学医院的早孕病房进行。所有疑似早孕并发症的妇女均进行临床和经阴道超声检查。对经超声检查确诊为输卵管异位妊娠的妇女进行手术或期待治疗。期待治疗的选择标准为临床稳定,腹痛轻微或无,超声检查未见明显腹腔积血,异位妊娠平均直径<30mm,未见胚胎心管活动,血清β-人绒毛膜促性腺激素(β-hCG)<1500IU/L,且患者同意。所有选择期待治疗的妇女均作为门诊患者进行随访,直至异位妊娠自然消退(临床症状缓解,血清β-hCG<20IU/L/尿妊娠试验阴性)或需要手术干预。我们记录了干预、并发症和随访的发生率。
在研究期间,339/11520(2.9%(95%可信区间,2.59-3.21%))名妇女被诊断为输卵管异位妊娠。6 名妇女选择参加正在进行的随机对照试验,并被排除在进一步分析之外。在其余的 333 名妇女中,有 165 名(49.5%(95%可信区间,44.2-55.0%))符合期待治疗标准;146/333(43.8%(95%可信区间,38.5-49.1%))名妇女选择期待治疗,104/333(31.2%(95%可信区间,26.2-36.2%))的所有输卵管异位妊娠无需任何干预即可自行消退。所有期待治疗失败的妇女均接受腹腔镜输卵管切除术/切开术治疗,无一人需要输血。
我们对输卵管异位妊娠进行期待治疗的临床方案可使超过三分之一的诊断为输卵管异位妊娠的妇女无需进行医疗或手术治疗,且不良结局的风险最小。