Kapp Nathalie, Lohr Patricia A, Ngo Thoai D, Hayes Jennifer L
Department of Reproductive Health and Research, World Health Organization, 20 Rue Appia, Geneva 27, Switzerland, CH-1211.
Cochrane Database Syst Rev. 2010 Feb 17(2):CD007207. doi: 10.1002/14651858.CD007207.pub2.
Preparing the cervix prior to surgical abortion is intended to make the procedure both easier and safer. Options for cervical preparation include osmotic dilators and pharmacologic agents. Many formulations and regimens are available, and recommendations from professional organizations vary for the use of preparatory techniques in women of different ages, parity or gestational age of the pregnancy.
To determine whether cervical preparation is necessary in the first trimester, and if so, which preparatory agent is preferred.
We searched Cochrane, Popline, Embase, Medline and Lilacs databases for randomised controlled trials investigating the use of cervical preparatory techniques prior to first trimester surgical abortion. In addition, we hand-searched key references and contacted authors to locate unpublished studies or studies not identified in the database searches.
Randomised controlled trials investigating any pharmacologic or mechanical method of cervical preparation, with the exception of nitric oxide donors (the subject of another Cochrane review), administered prior to first trimester surgical abortion were included. Outcome measures must have included the amount of cervical dilation achieved, the procedure duration or difficulty, side-effects, patient satisfaction or adverse events to be included in this review.
Trials under consideration were evaluated by considering whether inclusion criteria were met as well as methodologic quality. Fifty-one studies were included, resulting in 24 different cervical preparation comparisons. Results are reported as odds ratios (OR) for dichotomous outcomes and weighted mean differences for continuous data.
When compared to placebo, misoprostol (400-600 microg given vaginally or sublingually), gemeprost, mifepristone (200 or 600 mg), prostaglandin E and F(2alpha) (2.5 mg administered intracervically) demonstrated larger cervical preparation effects. When misoprostol was compared to gemeprost, misoprostol was more effective in preparing the cervix and was associated with fewer gastrointestinal side-effects. For vaginal administration, administration 2 hours prior was less effective than administration 3 hours prior to the abortion. Compared to oral misoprostol administration, the vaginal route was associated with significantly greater initial cervical dilation and lower rates of side-effects; however, sublingual administration 2-3 hours prior to the procedure demonstrated cervical effects superior to vaginal administration.When misoprostol (600 microg oral or 800 microg vaginal) was compared to mifepristone (200 mg administered 24 hours prior to procedure), misoprostol had inferior cervical preparatory effects. Compared to day-prior laminaria tents, 200 or 400 microg vaginal misoprostol showed no differences in the need for further mechanical dilation or length of the procedure; similarly, the osmotic dilators Lamicel and Dilapan showed no differences in cervical ripening when compared to gemeprost, although gemeprost had cervical effects which were superior to laminaria tents. Older prostaglandin regimens (sulprostone, prostaglandin E(2) andF(2alpha)) were associated with high rates of gastrointestinal side-effects and unplanned pregnancy expulsions. Few studies reported women's satisfaction with cervical preparatory techniques.
AUTHORS' CONCLUSIONS: Modern methods of cervical ripening are generally safe, although efficacy and side-effects between methods vary. Reports of adverse events such as cervical laceration or uterine perforation are uncommon overall in this body of evidence and no published study has investigated whether cervical preparation impacts these rare outcomes. Cervical preparation decreases the length of the abortion procedure; this may become increasingly important with increasing gestational age, as mechanical dilation at later gestational ages takes longer and becomes more difficult. These data do not suggest a gestational age where the benefits of cervical dilation outweigh the side-effects, including pain, that women experience with cervical ripening procedures or the prolongation of the time interval before procedure completion. Mifepristone 200 mg, osmotic dilators and misoprostol, 400microg administered either vaginally or sublingually, are the most effective methods of cervical preparation.
在进行人工流产手术前准备宫颈旨在使手术更简便、更安全。宫颈准备的方法包括渗透扩张器和药物制剂。有多种配方和方案可供选择,不同专业组织对于不同年龄、产次或妊娠孕周的女性使用准备技术的建议也有所不同。
确定孕早期是否有必要进行宫颈准备,如果有必要,哪种准备药物更佳。
我们检索了Cochrane、Popline、Embase、Medline和Lilacs数据库,以查找关于孕早期人工流产手术前使用宫颈准备技术的随机对照试验。此外,我们还手工检索了关键参考文献并联系了作者,以查找未发表的研究或在数据库检索中未找到的研究。
纳入在孕早期人工流产手术前使用任何药物或机械性宫颈准备方法(一氧化氮供体除外,其为另一项Cochrane综述的主题)的随机对照试验。结局指标必须包括宫颈扩张程度、手术持续时间或难度、副作用、患者满意度或不良事件,才能纳入本综述。
通过考虑是否符合纳入标准以及方法学质量来评估所考虑的试验。共纳入51项研究,产生了24种不同的宫颈准备比较。结果以二分结局的比值比(OR)和连续数据的加权平均差报告。
与安慰剂相比,米索前列醇(经阴道或舌下给予400 - 600微克)、吉美前列素、米非司酮(200或600毫克)、前列腺素E和F₂α(宫颈内给予2.5毫克)显示出更大的宫颈准备效果。将米索前列醇与吉美前列素比较时,米索前列醇在宫颈准备方面更有效,且胃肠道副作用较少。对于经阴道给药,流产前2小时给药的效果不如3小时给药。与口服米索前列醇相比,经阴道途径的初始宫颈扩张明显更大,副作用发生率更低;然而,术前2 - 3小时舌下给药的宫颈效果优于经阴道给药。当将米索前列醇(口服600微克或经阴道800微克)与米非司酮(术前24小时给予200毫克)比较时,米索前列醇的宫颈准备效果较差。与术前一天放置海藻棒相比,经阴道给予200或400微克米索前列醇在进一步机械扩张需求或手术时长方面无差异;同样,渗透扩张器Lamicel和Dilapan与吉美前列素相比,在宫颈成熟方面无差异,尽管吉美前列素的宫颈效果优于海藻棒。较老的前列腺素方案(硫前列酮、前列腺素E₂和F₂α)与高胃肠道副作用发生率和意外妊娠排出率相关。很少有研究报告女性对宫颈准备技术的满意度。
现代宫颈成熟方法总体上是安全的,尽管不同方法之间的疗效和副作用有所不同。在这组证据中,宫颈撕裂或子宫穿孔等不良事件的报告总体上并不常见,且尚无已发表的研究调查宫颈准备是否会影响这些罕见结局。宫颈准备可缩短流产手术时间;随着孕周增加,这可能变得越来越重要,因为孕晚期的机械扩张耗时更长且更困难。这些数据并未表明在哪个孕周宫颈扩张的益处超过女性在宫颈成熟过程中所经历的副作用,包括疼痛,或超过手术完成前时间间隔的延长。200毫克米非司酮、渗透扩张器和经阴道或舌下给予400微克米索前列醇是最有效的宫颈准备方法。