Kelly A J, Tan B
Clinical Effectiveness Support Unit, Royal College of Obstetricians and Gynaecologists, 27 Sussex Place, Regent's Park, London, UK, NW1 4RG.
Cochrane Database Syst Rev. 2001(3):CD003246. doi: 10.1002/14651858.CD003246.
Oxytocin is the commonest induction agent used worldwide. It has been used alone, in combination with amniotomy or following cervical ripening with other pharmacological or non-pharmacological methods. Prior to the introduction of prostaglandin agents oxytocin was used as a cervical ripening agent as well. In developed countries oxytocin alone is more commonly used in the presence of ruptured membranes whether spontaneous or artificial. In developing countries where the incidence of HIV is high, delaying amniotomy in labour reduces vertical transmission rates and hence the use of oxytocin with intact membranes warrants further investigation. This review will address the use of oxytocin alone for induction of labour. Amniotomy alone or oxytocin with amniotomy for induction of labour has been reviewed elsewhere in the Cochrane Library. Trials which consider concomitant administration of oxytocin and amniotomy will not be considered. This is one of a series of reviews of methods of cervical ripening and labour induction using a standardised methodology.
To determine the effects of oxytocin alone for third trimester cervical ripening or induction of labour in comparison with other methods of induction of labour or placebo/no treatment.
The Cochrane Pregnancy and Childbirth Group Trials Register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: May 2001.
The criteria for inclusion included the following: (1) clinical trials comparing vaginal prostaglandins used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions.
A strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data is to be extracted from the primary reviews into a series of secondary reviews, arranged by category of woman.
In total, 110 trials were considered; 52 have been excluded and 58 included examining a total of 11,129 women. Comparing oxytocin alone with expectant management: Oxytocin alone reduced the rate of unsuccessful vaginal delivery within 24 hours when compared with expectant management (8.3% versus 54%, relative risk (RR) 0.16, 95% confidence interval (CI) 0.10,0.25) but the caesarean section rate was increased (10.4% versus 8.9%, RR 1.17, 95% CI 1.01,1.36). This increase in caesarean section rate was not apparent in the subgroup analyses. Women were less likely to be unsatisfied with induction rather than expectant management, in the one trial reporting this outcome (5.5% versus 13.7%, RR 0.43, 95% CI 0.33, 0.56). Comparing oxytocin alone with vaginal prostaglandins: Oxytocin alone was associated with an increase in unsuccessful vaginal delivery within 24 hours (52% versus 28%, RR 1.85, 95% CI 1.41, 2.43), irrespective of membrane status, but there was no difference in caesarean section rates (11.4% versus 10%, RR 1.12, 95% CI 0.95, 1.33). Comparing oxytocin alone with intracervical prostaglandins: Oxytocin alone was associated with an increase in unsuccessful vaginal delivery within 24 hours when compared with intracervical PGE2 (51% versus 35%, RR 1.49, 95% CI 1.12,1.99). For all women with an unfavourable cervix regardless of membrane status, the caesarean section rates were increased (19.0% versus 13.1%, RR 1.42, 95% CI 1.11, 1.82).
REVIEWER'S CONCLUSIONS: Overall, comparison of oxytocin alone with either intravaginal or intracervical PGE2 reveals that the prostaglandin agents probably overall have more benefits than oxytocin alone. The amount of information relating to specific clinical subgroups is limited, especially with respect to women with intact membranes. Comparison of oxytocin alone to vaginal PGE2 in women with ruptured membranes reveals that both interventions are probably equally efficacious with each having some advantages and disadvantages over the others. With respect to current practice in women with ruptured membranes induction can be recommended by either method and in women with intact membranes there is insufficient information to make firm recommendations.
缩宫素是全球最常用的引产药物。它可单独使用,也可与人工破膜联合使用,或在采用其他药物或非药物方法使宫颈成熟后使用。在前列腺素类药物出现之前,缩宫素也被用作宫颈成熟剂。在发达国家,无论胎膜是自然破裂还是人工破裂,单独使用缩宫素更为常见。在艾滋病发病率较高的发展中国家,分娩时推迟人工破膜可降低垂直传播率,因此胎膜完整时使用缩宫素值得进一步研究。本综述将探讨单独使用缩宫素引产的情况。单独人工破膜或缩宫素联合人工破膜引产已在Cochrane图书馆的其他地方进行了综述。本综述不考虑同时使用缩宫素和人工破膜的试验。这是一系列采用标准化方法对宫颈成熟和引产方法进行综述的其中一篇。
与其他引产方法或安慰剂/不治疗相比,确定单独使用缩宫素进行孕晚期宫颈成熟或引产的效果。
Cochrane妊娠与分娩组试验注册库、Cochrane对照试验注册库以及相关论文的参考文献。最后检索时间:2001年5月。
纳入标准如下:(1)临床试验,将用于孕晚期宫颈成熟或引产的阴道前列腺素与安慰剂/不治疗或在预定义引产方法列表中位于其上方的其他方法进行比较;(2)随机分配至治疗组或对照组;(3)充分的分配隐藏;(4)违反分配管理但不足以实质性影响结论;(5)报告有临床意义的结局指标;(6)可根据随机分配进行分析的数据;(7)缺失数据不足以实质性影响结论。
制定了一项策略来处理与引产相关的大量且复杂的试验数据。这涉及两阶段的数据提取方法。初始数据提取在中心进行,并按照标准化方法纳入一系列按引产方法排列的主要综述中。数据将从主要综述中提取到一系列按女性类别排列的次要综述中。
共考虑了110项试验;排除了52项,纳入了58项,共涉及11129名女性。单独使用缩宫素与期待管理比较:与期待管理相比,单独使用缩宫素可降低24小时内阴道分娩失败率(8.3%对54%,相对危险度(RR)0.16,95%置信区间(CI)0.10,0.25),但剖宫产率增加(10.4%对8.9%,RR 1.17,95% CI 1.01,1.36)。在亚组分析中,剖宫产率的这种增加并不明显。在一项报告该结局的试验中,与期待管理相比,女性对引产不满意的可能性较小(5.5%对13.7%,RR 0.43,95% CI 0.33,0.56)。单独使用缩宫素与阴道前列腺素比较:无论胎膜状态如何,单独使用缩宫素与24小时内阴道分娩失败率增加相关(52%对28%,RR 1.85,95% CI 1.41,2.43),但剖宫产率无差异(11.4%对10%,RR 1.12,95% CI 0.95,1.33)。单独使用缩宫素与宫颈内前列腺素比较:与宫颈内PGE2相比,单独使用缩宫素与24小时内阴道分娩失败率增加相关(51%对35%,RR 1.49,95% CI 1.12,1.99)。对于所有宫颈条件不佳的女性,无论胎膜状态如何,剖宫产率均增加(19.0%对13.1%,RR 1.42,95% CI 1.11,1.82)。
总体而言,单独使用缩宫素与阴道或宫颈内PGE2比较表明,前列腺素类药物总体上可能比单独使用缩宫素更有益。与特定临床亚组相关的信息有限,尤其是关于胎膜完整的女性。胎膜破裂女性中单独使用缩宫素与阴道PGE2比较表明,两种干预措施可能同样有效,每种方法都有其优缺点。关于目前胎膜破裂女性的实践,两种方法均可推荐,而对于胎膜完整的女性,没有足够信息做出明确推荐。