Grimes David A, Smith M Susan, Witham Angela D
Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
BJOG. 2004 Feb;111(2):148-53. doi: 10.1046/j.1471-0528.2003.00044.x-i1.
To test the feasibility of mounting a randomised controlled trial comparing mifepristone-misoprostol versus dilation and evacuation (D&E) for midtrimester abortion.
Pilot randomised controlled trial.
University of North Carolina Hospitals, Chapel Hill, North Carolina.
Women aged 18 years or older and without prior uterine operations who requested abortion at 14-19 menstrual weeks of gestation from January 2002 to January 2003.
Participants received either mifepristone 200 mg by mouth followed in two days by vaginal then oral misoprostol (Aberdeen regimen) or D&E after one or two days of laminaria preparation. Care was provided by residents under faculty supervision.
Enrolment rate and acceptability of and adverse events associated with methods.
The trial was stopped at one year because of slow enrolment. Of 47 women eligible for the trial, 29 (62%) declined participation, primarily because of a preference for D&E abortion. Among the 18 participants enrolled, nine were randomised to treatment with mifepristone-misoprostol and 9 to D&E. Compared with D&E, mifepristone-misoprostol abortion caused more pain and adverse events, although none was serious.
Our findings concerning acceptability and adverse events should be considered hypothesis-generating; they may prove useful in planning a larger randomised controlled trial. Such a trial will be difficult to mount in the US. Hence, we suggest that it be done in a setting where labour-induction abortion is the norm.
检验开展一项随机对照试验的可行性，该试验比较米非司酮 - 米索前列醇与扩张刮宫术（D&E）用于孕中期流产的效果。
试点随机对照试验。
北卡罗来纳大学教堂山分校医院，北卡罗来纳州教堂山。
2002年1月至2003年1月期间，年龄在18岁及以上、既往无子宫手术史、妊娠14 - 19周要求流产的妇女。
参与者口服200毫克米非司酮，两天后经阴道然后口服米索前列醇（阿伯丁方案），或在放置海藻棒一或两天后进行扩张刮宫术。由住院医生在教员监督下提供护理。
入组率、方法的可接受性以及与之相关的不良事件。
由于入组缓慢，该试验在一年时停止。在47名符合试验条件的妇女中，29名（62%）拒绝参与，主要原因是更倾向于扩张刮宫术流产。在18名入组参与者中，9名被随机分配接受米非司酮 - 米索前列醇治疗，9名接受扩张刮宫术。与扩张刮宫术相比，米非司酮 - 米索前列醇流产引起更多疼痛和不良事件，尽管均不严重。
我们关于可接受性和不良事件的研究结果应被视为产生假设；它们可能在规划更大规模的随机对照试验中有用。在美国开展这样的试验将很困难。因此，我们建议在引产流产为常规做法的环境中进行。
