Boulvain M, Kelly A, Irion O
Hôpitaux Universitaires de Genève, Unite de Developpement en Obstetrique, CH-1211, Genève 14, Switzerland.
Cochrane Database Syst Rev. 2008 Jan 23(1):CD006971. doi: 10.1002/14651858.CD006971.
Prostaglandins have been used for cervical ripening and induction of labour since the 1970s. The goal of the administration of prostaglandins in the process of induction of labour is to achieve cervical ripening before the onset of contractions. One of the routes of administration that was proposed is intracervical. Using this route, prostaglandins are less easy to administer and the need for exposing the cervix may cause discomfort to the woman.
To determine the effects of intracervical prostaglandins for third trimester cervical ripening or induction of labour compared with placebo/no treatment and with vaginal prostaglandins (except misoprostol).
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (August 2007) and bibliographies of relevant papers.
Clinical trials comparing intracervical 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 (vaginal prostaglandins, except misoprostol).
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.
Fifty-six trials (7738 women) are included. INTRACERVICAL PGE2 WITH PLACEBO/NO TREATMENT: 28 TRIALS, 3764 WOMEN: Four studies reported the number of women who did not achieve vaginal delivery within 24 hours, showing a decreased risk with PGE2 (relative risk (RR) 0.61; 95% confidence interval (CI) 0.47 to 0.79). There was a small, and statistically non-significant, reduction of the risk of caesarean section when PGE2 was used (RR 0.88; 95% CI 0.77 to 1.00). The finding was statistically significant in a subgroup of women with intact membranes and unfavourable cervix only (RR 0.82; 95% CI 0.68 to 0.98). The risk of hyperstimulation with fetal heart rate (FHR) changes was not significantly increased (RR 1.21; 95% CI 0.72 to 2.05). However, the risk of hyperstimulation without FHR changes was significantly increased (RR 1.59; 95% CI 1.09 to 2.33. INTRACERVICAL PGE2 WITH INTRAVAGINAL PGE2: 29 TRIALS, 3881 WOMEN: The risk of not achieving vaginal delivery within 24 hours was increased with intracervical PGE2 (RR 1.26; 95% CI 1.12 to 1.41). There was no change in the risk of caesarean section (RR 1.07; 95% CI 0.93 to 1.22). The risks of hyperstimulation with FHR changes (RR 0.76; 95% CI 0.39 to 1.49) and without FHR changes (RR 0.80; 95% CI 0.56 to 1.15) were non-significantly different with the two methods of PGE2 administration. Only one trial with small sample size reported on women's views, with no difference between groups. INTRACERVICAL PGE2 LOW DOSE WITH INTRACERVICAL PGE2 HIGH DOSE: TWO TRIALS, 102 WOMEN: The trials are too small to provide any useful information.
AUTHORS' CONCLUSIONS: Intracervical prostaglandins are effective compared to placebo, but appear inferior when compared to intravaginal prostaglandins.
自20世纪70年代以来,前列腺素一直用于宫颈成熟和引产。在引产过程中使用前列腺素的目的是在宫缩开始前实现宫颈成熟。提出的给药途径之一是宫颈内给药。采用这种途径时,前列腺素较难给药,而且暴露宫颈的必要性可能会给女性带来不适。
确定与安慰剂/不治疗以及阴道前列腺素(米索前列醇除外)相比,宫颈内前列腺素用于孕晚期宫颈成熟或引产的效果。
我们检索了Cochrane妊娠与分娩组试验注册库(2007年8月)以及相关论文的参考文献。
将用于孕晚期宫颈成熟或引产的宫颈内前列腺素与安慰剂/不治疗或在预定义引产方法列表(阴道前列腺素,米索前列醇除外)中列于其上方的其他方法进行比较的临床试验。
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。
纳入了56项试验(7738名女性)。宫颈内给予PGE2与安慰剂/不治疗:28项试验,3764名女性:四项研究报告了24小时内未实现阴道分娩的女性数量,显示使用PGE2风险降低(相对风险(RR)0.61;95%置信区间(CI)0.47至0.79)。使用PGE2时,剖宫产风险有小幅降低,但在统计学上无显著意义(RR 0.88;95%CI 0.77至1.00)。在胎膜完整且宫颈条件不佳的女性亚组中,这一发现具有统计学意义(RR 0.82;95%CI 0.68至0.98)。伴有胎儿心率(FHR)变化的子宫过度刺激风险未显著增加(RR 1.21;95%CI 0.72至2.05)。然而,不伴有FHR变化的子宫过度刺激风险显著增加(RR 1.59;95%CI 1.09至2.33)。宫颈内给予PGE2与阴道内给予PGE2:29项试验,3881名女性:宫颈内给予PGE2时,24小时内未实现阴道分娩的风险增加(RR 1.26;95%CI 1.12至1.41)。剖宫产风险无变化(RR 1.07;95%CI 0.93至1.22)。两种PGE2给药方法在伴有FHR变化(RR 0.76;95%CI 0.39至1.49)和不伴有FHR变化(RR 0.80;95%CI 0.56至1.15)的子宫过度刺激风险方面无显著差异。只有一项小样本试验报告了女性的观点,两组之间无差异。低剂量宫颈内PGE2与高剂量宫颈内PGE2:两项试验,102名女性:试验规模太小,无法提供任何有用信息。
与安慰剂相比,宫颈内前列腺素是有效的,但与阴道内前列腺素相比似乎较差。