Verma Manju Lata, Singh Uma, Singh Nisha, Sankhwar Pushpa Lata, Qureshi Sabuhi
a Department of Obstetrics and Gynaecology , Hind Institute of Medical Sciences , Lucknow , Uttar Pradesh , India.
b Department of Obstetrics and Gynaecology , King George's Medical University , Lucknow , Uttar Pradesh , India.
Hum Fertil (Camb). 2017 Apr;20(1):43-47. doi: 10.1080/14647273.2016.1243817. Epub 2016 Nov 2.
In this prospective randomized parallel group study, subjects with a pregnancy of less than 63 d were randomized to receive either (i) 200 mg oral mifepristone plus 400 μg misoprostol per vaginally concurrently (group A); (ii) or the administration of misoprostol after 48 h (group B). Transvaginal sonography was performed on the 14th day of misoprostol administration to confirm complete abortion. The primary outcome was to compare the rates of complete abortion in two groups. Secondary outcomes were to compare induction abortion interval, side effects and compliance. A total of 200 subjects included in the study were randomized into groups A and B (100 each). Both the groups were comparable for age, parity, gestational age and history of previous abortion. The complete expulsion rate in group A was 96% (95% confidence interval (CI) 95.1-98.2%) and group B was 95% (95% CI 93.0-96.8%) (p > 0.100). A gestational age of more than 56 d was found to predict failure of treatment in both groups. The adverse effect profile in the two groups was the same. Efficacy of concurrent mifepristone and misoprostol in combination is similar to that when misoprostol is given 48 h later (ctri.nic.in CTRI/2010/091/001422).
在这项前瞻性随机平行组研究中,将妊娠少于63天的受试者随机分为两组,分别接受:(i)口服200毫克米非司酮加阴道内同时给予400微克米索前列醇(A组);(ii)48小时后给予米索前列醇(B组)。在给予米索前列醇第14天进行经阴道超声检查以确认完全流产。主要结局是比较两组的完全流产率。次要结局是比较引产流产间隔、副作用和依从性。该研究共纳入200名受试者,随机分为A组和B组(每组100名)。两组在年龄、产次、孕周和既往流产史方面具有可比性。A组的完全排出率为96%(95%置信区间(CI)95.1-98.2%),B组为95%(95%CI 93.0-96.8%)(p>0.100)。发现孕周超过56天可预测两组治疗失败。两组的不良反应情况相同。米非司酮与米索前列醇同时联合使用的疗效与48小时后给予米索前列醇的疗效相似(ctri.nic.in CTRI/2010/091/001422)。