Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Contraception. 2024 Apr;132:110364. doi: 10.1016/j.contraception.2024.110364. Epub 2024 Jan 11.
This study aimed to compare effectiveness and safety of cervical preparation with osmotic dilators plus same-day misoprostol or overnight mifepristone prior to dilation and evacuation (D&E).
We conducted a retrospective cohort analysis of 664 patients initiating abortion between 18 and 22 weeks at an ambulatory health center. We abstracted medical record data from two consecutive 12-month periods in 2017 to 2019. All patients received overnight dilators plus: 600 mcg buccal misoprostol 90 minutes before D&E (period 1); 200 mg oral mifepristone at time of dilators (period 2). Our primary outcome was procedure time. We report frequency of patients experiencing any acute complication, defined as unplanned procedure (i.e., reaspiration, cervical laceration repair, uterine balloon tamponade) or hospital transfer and bleeding complications.
We observed higher mean procedure time in the mifepristone group (9.7 ± 5.3 minutes vs 7.9 ± 4.4, p = 0.004). After adjusting for race, ethnicity, insurance, body mass index, parity, prior cesarean, prior uterine surgery, gestational age, provider, trainee participation, and long-acting reversible contraception initiation, the difference remained statistically significant (relative change 1.09, 95% CI 1.01, 1.17) but failed to reach our threshold for clinical significance. The use of additional misoprostol was more common in the mifepristone group, but the use of an additional set of dilators was not different between groups. Acute complications occurred at a frequency of 4.1% in misoprostol group and 4.3% in mifepristone group (p = 0.90).
We found procedure time to be longer with adjunctive mifepristone compared to misoprostol; however, this difference is unlikely to be clinically meaningful. Furthermore, the frequency of acute complications was similar between groups.
Overnight mifepristone at the time of cervical dilator placement is a safe and effective alternative to adjuvant same-day misoprostol for cervical preparation prior to D&E and may offer benefits for clinic flow and patient experience.
本研究旨在比较在扩张和排空(D&E)前使用渗透扩张器联合同日米索前列醇或隔夜米非司酮进行宫颈准备的有效性和安全性。
我们对在一家门诊保健中心进行的 18 至 22 周之间的流产的 664 名患者进行了回顾性队列分析。我们从 2017 年至 2019 年连续两个 12 个月的病历数据中提取了信息。所有患者均接受过夜扩张器加用:D&E 前 90 分钟给予 600mcg 颊部米索前列醇(第 1 期);扩张器时给予 200mg 口服米非司酮(第 2 期)。我们的主要结局是手术时间。我们报告了任何急性并发症(即计划外手术(即再吸入、宫颈裂伤修复、子宫球囊填塞)或医院转移和出血并发症)的患者的频率。
我们观察到米非司酮组的平均手术时间更长(9.7±5.3 分钟 vs 7.9±4.4,p=0.004)。在校正种族、民族、保险、体重指数、产次、剖宫产史、子宫手术史、妊娠年龄、提供者、受训者参与和长效可逆避孕措施的启动后,差异仍然具有统计学意义(相对变化 1.09,95%CI 1.01,1.17),但未达到我们的临床意义阈值。米非司酮组更常使用额外的米索前列醇,但两组之间使用额外一套扩张器并无差异。米索前列醇组发生急性并发症的频率为 4.1%,米非司酮组为 4.3%(p=0.90)。
我们发现与米索前列醇相比,附加米非司酮的手术时间更长;然而,这种差异不太可能具有临床意义。此外,两组之间的急性并发症发生率相似。
在宫颈扩张器放置时使用隔夜米非司酮是 D&E 前宫颈准备中替代辅助同日米索前列醇的安全有效方法,并且可能对就诊流程和患者体验有好处。