Abstract：
BACKGROUND: This prospective single-arm study was conducted to understand the expulsion rate of the gestational sac in the management of early pregnancy loss (EPL).
METHODS: We recruited 441 participants; 188 met eligibility criteria. Participants were 18 years of age and older who experienced a confirmed early pregnancy loss (<12 weeks gestational age) defined by an intrauterine pregnancy with a non-viable embryonic or anembryonic gestational sac with no fetal heart activity. Participants were given 200 mg of mifepristone pretreatment orally followed by two doses of misoprostol 800 mcg vaginally after 24 and 48 hours. Participants were seen in follow-up on day 14 to confirm the absence of a gestational sac, classified as treatment success. For failed treatment (defined by retained gestational sac), we offered expectant management or a third dose of misoprostol and/or dilatation and curettage (D & C). We followed all participants for 30 days. We collected data on overtreatment for retained products of conception and hospital admissions for adverse events.
RESULTS: 181 participants followed the protocol, and 169 (93.3%) participants had a complete expulsion of the gestational sac by the second visit (day 14). Twelve (6.6%) failed the treatment and one had an adverse event of heavy vaginal bleeding requiring D & C. Despite the expulsion of the gestational sac, 29 cases (17.1%) at subsequent follow-up were diagnosed as retained products of conception based on ultrasound assessment of thickened endometrium.
CONCLUSIONS: Pretreatment with mifepristone followed by 2 doses of misoprostol with a 14-day follow-up resulted in a high expulsion rate and is a safe management option for EPL.
METHODS: We recruited 441 participants; 188 met eligibility criteria. Participants were 18 years of age and older who experienced a confirmed early pregnancy loss (<12 weeks gestational age) defined by an intrauterine pregnancy with a non-viable embryonic or anembryonic gestational sac with no fetal heart activity. Participants were given 200 mg of mifepristone pretreatment orally followed by two doses of misoprostol 800 mcg vaginally after 24 and 48 hours. Participants were seen in follow-up on day 14 to confirm the absence of a gestational sac, classified as treatment success. For failed treatment (defined by retained gestational sac), we offered expectant management or a third dose of misoprostol and/or dilatation and curettage (D & C). We followed all participants for 30 days. We collected data on overtreatment for retained products of conception and hospital admissions for adverse events.
RESULTS: 181 participants followed the protocol, and 169 (93.3%) participants had a complete expulsion of the gestational sac by the second visit (day 14). Twelve (6.6%) failed the treatment and one had an adverse event of heavy vaginal bleeding requiring D & C. Despite the expulsion of the gestational sac, 29 cases (17.1%) at subsequent follow-up were diagnosed as retained products of conception based on ultrasound assessment of thickened endometrium.
CONCLUSIONS: Pretreatment with mifepristone followed by 2 doses of misoprostol with a 14-day follow-up resulted in a high expulsion rate and is a safe management option for EPL.
摘要：
背景：进行了这项前瞻性单臂研究，以了解早期妊娠丢失（EPL）管理中孕囊的排出率。
方法：我们招募了441名参与者；188名符合资格标准。参与者年龄在18岁及以上，经历了确认的早期妊娠丢失（<12周孕龄），定义为宫内妊娠，无存活的胚胎或胚胎孕囊，无胎儿心脏活动。参与者口服200mg米非司酮预处理，然后在24和48小时后阴道给予两剂800mcg米索前列醇。在第14天的随访中观察参与者，以确认没有孕囊，归类为治疗成功。对于失败的治疗（由保留的孕囊定义），我们提供了期待管理或第三剂米索前列醇和/或扩张和刮治（D＆C）。我们跟踪所有参与者30天。我们收集了保留妊娠产品的过度治疗和不良事件入院的数据。
结果：181名参与者遵循了协议，在第二次访视(第14天)时,169例(93.3%)参与者的孕囊完全排出.12例（6.6％）治疗失败，1例发生严重阴道出血的不良事件，需要D＆C。尽管孕囊排出，29例（17.1%）在随后的随访中根据超声评估增厚的子宫内膜被诊断为保留的受孕产物。
结论：用米非司酮预处理，然后2剂米索前列醇，随访14天，可导致高排出率，是EPL的安全管理选择。
方法：我们招募了441名参与者；188名符合资格标准。参与者年龄在18岁及以上，经历了确认的早期妊娠丢失（<12周孕龄），定义为宫内妊娠，无存活的胚胎或胚胎孕囊，无胎儿心脏活动。参与者口服200mg米非司酮预处理，然后在24和48小时后阴道给予两剂800mcg米索前列醇。在第14天的随访中观察参与者，以确认没有孕囊，归类为治疗成功。对于失败的治疗（由保留的孕囊定义），我们提供了期待管理或第三剂米索前列醇和/或扩张和刮治（D＆C）。我们跟踪所有参与者30天。我们收集了保留妊娠产品的过度治疗和不良事件入院的数据。
结果：181名参与者遵循了协议，在第二次访视(第14天)时,169例(93.3%)参与者的孕囊完全排出.12例（6.6％）治疗失败，1例发生严重阴道出血的不良事件，需要D＆C。尽管孕囊排出，29例（17.1%）在随后的随访中根据超声评估增厚的子宫内膜被诊断为保留的受孕产物。
结论：用米非司酮预处理，然后2剂米索前列醇，随访14天，可导致高排出率，是EPL的安全管理选择。
