Comparison of the efficacy and safety of two combined misoprostol regimens for second trimester medical abortion

Abstract

Objective

The aim of the study was to compare the efficacy and safety of two combined misoprostol regimens for second trimester medical abortion.

Methods

This was a retrospective cohort study examining data on singleton pregnancies that underwent second trimester medical abortion between November 2011 and November 2019 in a tertiary care centre in northern Greece. In the first study period (November 2011 to August 2015), the management protocol (protocol 1) consisted of 800 μg vaginal misoprostol followed by 400 μg oral misoprostol, every 3 h, for up to five doses. In the second study period (September 2015 to November 2019), a new protocol (protocol 2) was introduced, where the oral route was changed to sublingual, using the same dosage. The two routes were compared in terms of efficacy and safety.

Results

The study comprised 85 women: 43 (50.6%) received the protocol 1 regimen (vaginal-oral), while 42 (49.4%) received the protocol 2 regimen (vaginal-sublingual). The groups did not differ in terms of maternal age, gestational age and parity. Sublingual misoprostol was more effective than oral misoprostol, both in terms of dose needed (median 1600 μg vs 2000 μg; p = 0.031) and induction-to-abortion interval (8 h vs 11 h; p = 0.001). Surgical evacuation due to incomplete abortion was necessary in 11.9% of women in the sublingual group vs 18.6% in the oral group (p = 0.394). Women in the sublingual group reported a higher rate of severe pain (odds ratio [OR] 6.061; 95% confidence interval [95% CI] 1.240, 29.619) and shivering (OR 4.632; 95% CI 1.788, 11.995).

Conclusion

The administration of vaginal-sublingual misoprostol, when compared with the vaginal-oral regimen, was associated with a shorter induction-to-abortion interval but a higher incidence of severe pain and shivering.

摘要

目的：比较两种米索前列醇联合方案在治疗妊娠中期药物流产的疗效和安全性。

方法：这是一项回顾性队列研究, 研究了2011年11月至2019年11月在希腊北部的一个三级保健中心进行的单胎妊娠患者中期药物流产的数据。在第一个研究期间（2011年11月至2015年8月）, 管理方案（方案1）包括800lg阴道米索前列醇和400lg口服米索前列醇, 每3个小时一次, 最多5次。在第二个研究阶段（2015年9月至2019年11月）, 采用了一种新的方案（方案2）, 将口服途径改为舌下含服, 应用相同的剂量。比较两种途径的疗效和安全性。

结果：该研究包括了85名女性：43人（50.6%）接受方案1（阴道-口服）方案, 42人（49.4%）接受方案2（阴道-舌下）方案。两组在产妇年龄、孕龄和胎次方面没有差异。在所需剂量方面, 舌下米索前列醇比口服米索前列醇更有效（中位数为1600lg vs 2000lg；p=0.031）和诱导流产间隔时间（8h vs 11h；p=0.001）。在舌下组中11.9%的女性因不完全流产而需要手术治疗, 而在口服组中18.6%的女性需要手术治疗（p=0.394）。舌下含服组的女性报告了更多严重的疼痛发生（优势比[OR]6.061;95%的置信区间[95% CI]1.240, 29.619）和寒战（OR 4.632; 95% CI 1.788, 11.995）。

结论：与阴道-口服方案相比, 阴道-舌下米索前列醇的应用与较短的引产到流产周期相关, 但剧烈疼痛和寒战的发生率较高。

Keywords:

• Medical abortion
• misoprostol
• oral
• second trimester
• sublingual

Disclosure statement

No potential conflict of interest was reported by the author(s).