左炔诺孕酮皮下埋植即刻与延迟置入对药物流产效果及重复妊娠的影响：一项随机对照试验。
Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.
机构信息
Gynuity Health Projects, New York, New York; the Departments of Medicine and Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Secretariat of Health, Mexico City, Mexico; Planned Parenthood of Southern New England, New Haven, Connecticut; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Planned Parenthood League of Massachusetts, Boston, Massachusetts; Planned Parenthood of the Pacific Southwest, San Diego, California; Planned Parenthood Northern California, San Rafael, California; and Johns Hopkins University, Baltimore, Maryland.
出版信息
Obstet Gynecol. 2016 Feb;127(2):306-12. doi: 10.1097/AOG.0000000000001274.
OBJECTIVE
To evaluate the effect of insertion of etonogestrel implants with mifepristone compared with after the abortion on the risks of medical abortion failure and repeat pregnancy over the subsequent 6 months.
METHODS
In a randomized trial, we assigned patients undergoing medical abortion to receive etonogestrel implants either with the mifepristone (Quickstart group) or after the abortion (Afterstart group). We followed them for 7 months to ascertain abortion outcome, pregnancies, and contraception use.
RESULTS
Between September 2013 and August 2014, we enrolled 236 participants in the Quickstart group and 240 in the Afterstart group. To examine abortion failure, we conducted a noninferiority analysis from which we excluded nine participants who had missing outcome data and four with specified protocol violations. Of the rest, 9 of 229 (3.9%) and 9 of 234 (3.8%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the difference of 0.08% (90% confidence interval -3.1% to 3.3%) excluded our prestipulated noninferiority margin of 5 percentage points. Among participants with pregnancy follow-up through 6 months, 1 of 213 (0.5%) and 3 of 208 (1.4%) in the Quickstart and Afterstart groups, respectively, became pregnant within that time; 6-month pregnancy rates did not differ significantly by group (exact log-rank test, P=.28). At enrollment, significantly more participants in the Quickstart group than in the Afterstart group were satisfied with their group assignments (187/236 [79%] compared with 129/240 [54%], respectively; P<.001).
CONCLUSION
Insertion of etonogestrel implants with mifepristone did not appreciably increase medical abortion failure risk and it enhanced patient satisfaction, but we found no evidence that it decreased repeat pregnancy rates.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, www.clinicaltrials.gov, NCT01902485.
目的
评估米非司酮与依托孕烯植入物联合使用（快启动组）与流产后使用（后启动组）对随后 6 个月内药物流产失败和再次妊娠风险的影响。
方法
在一项随机试验中，我们将接受药物流产的患者分为快启动组和后启动组，分别在米非司酮给药时（快启动组）或流产后（后启动组）放置依托孕烯植入物。我们随访了他们 7 个月，以确定流产结局、妊娠和避孕措施的使用情况。
结果
2013 年 9 月至 2014 年 8 月，我们将 236 名参与者纳入快启动组，240 名参与者纳入后启动组。为了检查流产失败，我们进行了一项非劣效性分析，排除了 9 名结局数据缺失和 4 名违反方案的参与者。在其余的参与者中，快启动组和后启动组分别有 9 例（3.9%）和 9 例（3.8%）需要手术来完成流产；0.08%（90%置信区间-3.1%至 3.3%）的差异排除了我们规定的 5 个百分点的非劣效性边界。在随访至 6 个月的妊娠参与者中，快启动组和后启动组分别有 1 例（0.5%）和 3 例（1.4%）在该时间内妊娠；两组 6 个月妊娠率无显著差异（确切对数秩检验，P=.28）。在入组时，快启动组中明显有更多的参与者对他们的分组感到满意（187/236 [79%]比 129/240 [54%]，P<.001）。
结论
米非司酮与依托孕烯植入物联合使用并没有显著增加药物流产失败的风险，反而提高了患者的满意度，但我们没有证据表明它降低了再次妊娠的发生率。
临床试验注册
ClinicalTrials.gov，www.clinicaltrials.gov，NCT01902485。
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