Rohwer Anke C, Khondowe Oswell, Young Taryn
Centre for Evidence-based Health Care, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009243. doi: 10.1002/14651858.CD009243.pub3.
Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and asphyxia and requires early detection and appropriate clinical response. The risks for complications of prolonged labour are much greater in poor resource settings. Active management of labour versus physiological, expectant management, has shown to decrease the occurrence of prolonged labour. Administering antispasmodics during labour could also lead to faster and more effective dilatation of the cervix. Interventions to shorten labour, such as antispasmodics, can be used as a preventative or a treatment strategy in order to decrease the incidence of prolonged labour. As the evidence to support this is still largely anecdotal around the world, there is a need to systematically review the available evidence to obtain a valid answer.
To assess the effects of antispasmodics on labour in term pregnancies.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 February 2013), the ProQuest dissertation and thesis database, the dissertation database of the University of Stellenbosch and Google Scholar (28 February 2013) and reference lists of articles. We also contacted pharmaceutical companies and experts in the field. We did not apply language restrictions.
Randomised controlled trials comparing antispasmodics with placebo or no medication in women with term pregnancies.
Two review authors independently screened abstracts and selected studies for inclusion, assessed risk of bias and extracted data. Data were checked for accuracy. We contacted trial authors when data were missing.
Twenty-one trials (n = 3286) were included in the review. Seventeen trials (n = 2617) were included in the meta-analysis. Antispasmodics used included valethamate bromide, hyoscine butyl-bromide, drotaverine hydrochloride, rociverine and camylofin dihydrochloride. Most studies included antispasmodics as part of their package of active management of labour. Overall, the quality of studies was poor, as only four trials were assessed as low risk of bias. Thirteen trials (n = 1995) reported on the duration of first stage of labour, which was significantly reduced by an average of 74.34 minutes when antispasmodics were administered (mean difference (MD) -74.34 minutes; 95% confidence Interval (CI) -98.76 to -49.93). Seven studies (n = 797) reported on the total duration of labour, which was significantly reduced by an average of 85.51 minutes (MD -85.51 minutes; 95% CI -121.81 to -49.20). Six studies (n = 820) had data for the outcome: rate of cervical dilatation. Administration of antispasmodics significantly increased the rate of cervical dilatation by an average of 0.61 cm/hour (MD 0.61 cm/hour; 95% CI 0.34 to 0.88). Antispasmodics did not affect the duration of second and third stage of labour. The rate of normal vertex deliveries was not affected either. Only one study explored pain relief following administration of antispasmodics and no conclusions can be drawn on this outcome. There was significant heterogeneity for most outcomes and therefore, we undertook random-effects meta-analysis. Subgroup analysis was undertaken to explore heterogeneity, but remained largely unexplained. Maternal and neonatal adverse events were reported inconsistently. The main maternal adverse event reported was tachycardia. No serious neonatal adverse events were reported.
AUTHORS' CONCLUSIONS: There is low quality evidence that antispasmodics reduce the duration of first stage of labour and increase the cervical dilatation rate. There is very low quality evidence that antispasmodics reduce the total duration of labour. There is moderate quality evidence that antispasmodics do not affect the rate of normal vertex deliveries. There is insufficient evidence to make any conclusions regarding the safety of these drugs for both mother and baby. Large, rigorous randomised controlled trials are needed to evaluate the effect of antispasmodics on prolonged labour and to evaluate their effect on labour in a context of expectant management of labour.
产程延长会因产妇衰竭、产后出血及败血症、胎儿窘迫和窒息等风险增加,导致孕产妇和新生儿死亡率及发病率上升,因此需要早期发现并做出适当的临床应对。在资源匮乏地区,产程延长引发并发症的风险要高得多。与生理性、期待性管理相比,产程积极管理已显示可减少产程延长的发生。分娩期间使用解痉药也可能使宫颈扩张更快、更有效。缩短产程的干预措施,如解痉药,可作为预防或治疗策略,以降低产程延长的发生率。由于世界各地支持这一观点的证据大多仍为轶事性的,因此有必要系统地回顾现有证据以获得有效答案。
评估解痉药对足月妊娠分娩的影响。
我们检索了Cochrane妊娠与分娩组试验注册库(2013年2月28日)、ProQuest学位论文数据库、斯泰伦博斯大学学位论文数据库和谷歌学术(2013年2月28日)以及文章的参考文献列表。我们还联系了制药公司和该领域的专家。我们未设置语言限制。
比较解痉药与安慰剂或未用药对足月妊娠女性影响的随机对照试验。
两位综述作者独立筛选摘要并选择纳入研究,评估偏倚风险并提取数据。检查数据的准确性。数据缺失时我们与试验作者联系。
本综述纳入了21项试验(n = 3286)。荟萃分析纳入了17项试验(n = 2617)。使用的解痉药包括溴戊乙胺、丁溴东莨菪碱、盐酸屈他维林、罗西维林和盐酸卡米罗芬。大多数研究将解痉药作为其产程积极管理方案的一部分。总体而言,研究质量较差,因为只有4项试验被评估为低偏倚风险。13项试验(n = 1995)报告了第一产程的时长,使用解痉药时第一产程平均显著缩短74.34分钟(平均差(MD)-74.34分钟;95%置信区间(CI)-98.76至-49.93)。7项研究(n = 797)报告了总产程,总产程平均显著缩短85.51分钟(MD -85.51分钟;95% CI -121.81至-49.20)。6项研究(n = 820)有宫颈扩张率这一结局的数据。使用解痉药使宫颈扩张率平均显著增加0.61厘米/小时(MD 0.6厘米/小时;95% CI 0.34至0.88)。解痉药不影响第二和第三产程的时长。枕前位正常分娩率也未受影响。只有一项研究探讨了解痉药给药后的疼痛缓解情况,对此结局无法得出结论。大多数结局存在显著异质性,因此,我们进行了随机效应荟萃分析。进行了亚组分析以探讨异质性,但很大程度上仍无法解释。孕产妇和新生儿不良事件的报告不一致。报告的主要孕产妇不良事件是心动过速。未报告严重的新生儿不良事件。
低质量证据表明解痉药可缩短第一产程时长并增加宫颈扩张率。极低质量证据表明解痉药可缩短总产程。中等质量证据表明解痉药不影响枕前位正常分娩率。没有足够证据就这些药物对母婴的安全性得出任何结论。需要开展大型、严谨的随机对照试验来评估解痉药对产程延长的影响,并在产程期待性管理背景下评估其对分娩的影响。