口腔米索前列醇与合成渗透压宫颈扩张器在手术流产前的比较：一项随机对照试验。
Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial.
机构信息
Department of Obstetrics, Gynecology, and Reproductive Biology and the Center for Clinical Investigation, Brigham and Women's Hospital, Harvard Medical School, and Planned Parenthood League of Massachusetts, Boston, Massachusetts; and the Department of Obstetrics and Gynecology, Women and Infant's Hospital, Providence, Rhode Island.
出版信息
Obstet Gynecol. 2013 Jul;122(1):57-63. doi: 10.1097/AOG.0b013e3182983889.
OBJECTIVE
To compare the efficacy and acceptability of buccal misoprostol or a synthetic osmotic cervical dilator for cervical preparation before same-day late first-trimester and early second-trimester surgical abortion.
METHODS
In this randomized, double-blind trial, we compared 400 micrograms of buccal misoprostol with one synthetic osmotic cervical dilator administered 3-4 hours before surgical abortion among women at 12-15 weeks of gestation. The primary outcome was mean cervical circumferential dilation at the time of surgery. Randomization was stratified by parity and sample size calculated to detect a 3-French difference between groups with 90% power with a two-sided α of .05. Secondary outcomes included ease of further mechanical dilation, procedure time, complications, ripening and procedural pain, and participants' satisfaction.
RESULTS
One hundred twenty-five women were randomized with a mean gestational age of 13 3/7 weeks. Treatment with the synthetic osmotic dilator and buccal misoprostol resulted in similar preoperative dilation (mean French 33.9 compared with 32.1, P=.065). Procedure time, procedural pain, number of complications, and participants' satisfaction and preferences did not differ between treatment groups. Misoprostol participants experienced more pain during ripening (P=.008). All but six participants, three in each arm, required mechanical dilation at the time of the procedure. This manual dilation was subjectively easier in participants who received the synthetic osmotic cervical dilator (P=.015). All participants were able to have their procedure in 1 day without further cervical preparation.
CONCLUSION
Either buccal misoprostol or a synthetic osmotic cervical dilator provides adequate dilation for same-day late first-trimester and early second-trimester abortion. Despite more pain with misoprostol, patient satisfaction with misoprostol and the synthetic dilator is similar.
CLINICAL TRIAL REGISTRATION
www.clinicaltrials.gov, NCT00835731.
LEVEL OF EVIDENCE
I.
目的
比较在同日行晚期 1 孕期和早期 2 孕期手术流产前，使用颊黏膜米索前列醇与合成渗透宫颈扩张器进行宫颈准备的疗效和可接受性。
方法
在这项随机、双盲试验中，我们比较了在妊娠 12-15 周时，400 微克颊黏膜米索前列醇与在手术流产前 3-4 小时使用的一种合成渗透宫颈扩张器。主要结局是手术时的宫颈周径平均扩张度。根据产次和样本量进行分层随机化，计算出 90%效能和双侧 α=.05 时两组之间 3-French 差异的检测能力。次要结局包括进一步机械扩张的容易程度、手术时间、并发症、成熟和手术疼痛以及参与者的满意度。
结果
125 名妇女被随机分为两组，平均妊娠龄为 13 周 3 天。合成渗透扩张器和颊黏膜米索前列醇治疗导致术前扩张相似（平均法国 33.9 与 32.1，P=.065）。手术时间、手术疼痛、并发症数量以及治疗组之间的参与者满意度和偏好没有差异。米索前列醇组在成熟过程中疼痛更严重（P=.008）。所有参与者，除了每臂各 6 名参与者外，在手术时都需要进行机械扩张。在使用合成渗透宫颈扩张器的参与者中，这种手动扩张主观上更容易（P=.015）。所有参与者都能够在 1 天内无需进一步的宫颈准备进行手术。
结论
颊黏膜米索前列醇或合成渗透宫颈扩张器均可为同日行晚期 1 孕期和早期 2 孕期流产提供足够的扩张。尽管米索前列醇引起更多疼痛，但米索前列醇和合成扩张器的患者满意度相似。
临床试验注册
www.clinicaltrials.gov，NCT00835731。
证据水平
I。
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