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海藻棒与米索前列醇用于孕中期手术流产前宫颈准备的比较:一项随机临床试验

Laminaria vs. vaginal misoprostol for cervical preparation before second-trimester surgical abortion: a randomized clinical trial.

作者信息

Sagiv Ron, Mizrachi Yossi, Glickman Hagit, Kerner Ram, Keidar Ran, Bar Jacob, Golan Abraham

机构信息

Department of Obstetrics and Gynecology, E. Wolfson Medical Center, Holon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

Department of Obstetrics and Gynecology, E. Wolfson Medical Center, Holon, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

出版信息

Contraception. 2015 May;91(5):406-11. doi: 10.1016/j.contraception.2015.01.018. Epub 2015 Jan 31.

Abstract

OBJECTIVE

To compare the efficacy and tolerability of vaginal misoprostol and laminaria for cervical preparation before second-trimester surgical abortion.

STUDY DESIGN

We performed a prospective, randomized trial comparing midnight administration of misoprostol 600 mcg vaginally to midnight placement of laminaria, before surgical abortions among women at 13-20 weeks of gestation. The primary outcome was preoperative cervical dilation. Secondary outcomes were the need for further dilation, procedure duration and difficulty, immediate complications and side effects.

RESULTS

Eighty-four women were randomized, with a median gestational age of 16.5 weeks. The mean time interval between misoprostol and laminaria placement and dilatation and evacuation initiation was 11.0±2.9 and 11.2±2.0h, respectively (p=.17). Cervical dilation was not greater in the laminaria group as compared to the misoprostol group (12.8 vs. 12.4mm, respectively; p=.32). No difference was demonstrated regarding the need for additional dilation or the difficulty of the procedure. Procedures performed after laminaria insertion were 1 min longer (median 11 vs. 10 min, p=.04). Participants found laminaria placement more uncomfortable than vaginal misoprostol placement. Other than pain, additional side effects occurred only in the misoprostol group, primarily nausea and vomiting. One participant in the misoprostol group experienced fetal expulsion during the night before the intended procedure.

CONCLUSION

Either vaginal misoprostol or laminaria provides adequate dilation for second-trimester surgical abortion. Laminaria causes more pain at insertion and misoprostol causes more side effects.

IMPLICATIONS STATEMENT

We found that cervical preparation in an inpatient setting for approximately 11h with misoprostol 600 mcg vaginally is comparable to 11h of laminaria. However, given the potential for spontaneous expulsion and more side effects with misoprostol, laminaria is likely a better general option in such a setting.

摘要

目的

比较米索前列醇阴道给药与海藻棒用于孕中期手术流产前宫颈准备的疗效和耐受性。

研究设计

我们进行了一项前瞻性随机试验,比较在妊娠13 - 20周的妇女中,于午夜阴道给予600微克米索前列醇与午夜放置海藻棒用于手术流产前的情况。主要结局为术前宫颈扩张情况。次要结局包括进一步扩张的需求、手术持续时间和难度、即刻并发症及副作用。

结果

84名妇女被随机分组,中位孕周为16.5周。米索前列醇给药与海藻棒放置及扩张和清宫术开始之间的平均时间间隔分别为11.0±2.9小时和11.2±2.0小时(p = 0.17)。与米索前列醇组相比,海藻棒组的宫颈扩张程度并无更大差异(分别为扩张12.8毫米和12.4毫米;p = 0.32)。在额外扩张需求或手术难度方面未显示出差异。放置海藻棒后进行的手术时间长1分钟(中位时间分别为11分钟和10分钟,p = 0.04)。参与者发现放置海藻棒比阴道给予米索前列醇更不舒服。除疼痛外,额外的副作用仅发生在米索前列醇组,主要是恶心和呕吐。米索前列醇组有1名参与者在预定手术前一晚发生了胎儿排出。

结论

米索前列醇阴道给药或海藻棒均可为孕中期手术流产提供足够的宫颈扩张。放置海藻棒时疼痛更明显,米索前列醇则副作用更多。

意义声明

我们发现,在住院环境中,阴道给予600微克米索前列醇进行约11小时的宫颈准备与使用海藻棒11小时相当。然而,鉴于米索前列醇有自发排出胎儿的可能性及更多副作用,在此种情况下海藻棒可能是更好的总体选择。

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