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门诊使用米索前列醇与地诺前列酮凝胶进行引产术前宫颈成熟度的比较:一项随机对照试验。

Outpatient misoprostol compared with dinoprostone gel for preinduction cervical ripening: a randomized controlled trial.

作者信息

Meyer Marjorie, Pflum Jeannie, Howard Diantha

机构信息

University of Vermont, Burlington, USA.

出版信息

Obstet Gynecol. 2005 Mar;105(3):466-72. doi: 10.1097/01.AOG.0000152341.31873.d9.

Abstract

OBJECTIVE

To determine whether a single outpatient dose of intravaginal misoprostol (versus intracervical dinoprostone gel) reduces the oxytocin use for induction. Despite the numerous trials examining misoprostol for induction, the efficacy of a single outpatient dose of misoprostol followed by oxytocin induction is unknown.

METHODS

Patients with a term, vertex, singleton pregnancy and a Bishop score of 6 or less were randomly assigned to receive misoprostol (n = 42, 0.25 microg intravaginally) or dinoprostone gel (n = 42, 0.5 mg intracervically) the evening before oxytocin induction. Patients were monitored for 3 hours after administration and discharged to home if fetal assessment was reassuring, for readmission the next morning for oxytocin. Primary outcomes were oxytocin dose, time, and dose intensity (dose divided by duration). Secondary outcomes were incidence of labor, uterine hyperstimulation, cesarean delivery, Apgar score. Statistics used were chi(2), Student t test, Mann-Whitney rank sum test, and Fisher exact test. P < .05 was accepted as statistically significant.

RESULTS

A single dose of misoprostol significantly decreased the cumulative dose of oxytocin, the cumulative time of oxytocin administration, and the dose intensity of oxytocin (dose divided by time). Data are as follows (mean +/- standard error of the mean): oxytocin dose-dinoprostone 10,929 +/- 219 mU, misoprostol 6,081 +/- 170 mU, P = .008; oxytocin time-dinoprostone 798 +/- 11 minutes, misoprostol 531 +/- 11 minutes, P = .009; dose intensity-dinoprostone 11.3 +/- 0.1 mU/min, misoprostol 7.4 +/- 0.2 mU/min, P = .003. Misoprostol induced labor during the ripening period in 19 of 41 of patients, compared with 6 of 42 after dinoprostone (P = .002). There was no difference in cesarean delivery (dinoprostone, 8/42; misoprostol, 9/42; P = 1.00). There was no difference in short-term neonatal outcome. No patient had hyperstimulation or required cesarean delivery for nonreassuring fetal assessment during the ripening period.

CONCLUSION

A single dose of misoprostol administered in the outpatient setting significantly decreases oxytocin use, largely due to labor within the ripening period.

摘要

目的

确定门诊单次阴道给予米索前列醇(与宫颈内给予地诺前列酮凝胶相比)是否能减少引产时缩宫素的使用。尽管有大量关于米索前列醇用于引产的试验,但门诊单次给予米索前列醇后继以缩宫素引产的疗效尚不清楚。

方法

足月、头先露、单胎妊娠且 Bishop 评分小于或等于 6 分的患者,在缩宫素引产的前一晚被随机分配接受米索前列醇(n = 42,阴道给予 0.25μg)或地诺前列酮凝胶(n = 42,宫颈内给予 0.5mg)。给药后对患者监测 3 小时,若胎儿评估结果令人放心则让患者回家,次日早晨再入院接受缩宫素引产。主要结局指标为缩宫素剂量、时间及剂量强度(剂量除以持续时间)。次要结局指标为临产发生率、子宫过度刺激、剖宫产、阿氏评分。所采用的统计学方法为卡方检验、Student t 检验、Mann-Whitney 秩和检验及 Fisher 确切概率法。P <.05 被认为具有统计学意义。

结果

单次给予米索前列醇显著降低了缩宫素的累积剂量、缩宫素给药的累积时间及缩宫素的剂量强度(剂量除以时间)。数据如下(均值±均值标准误):缩宫素剂量 - 地诺前列酮 10,929±219mU,米索前列醇 6,081±170mU,P =.008;缩宫素时间 - 地诺前列酮 798±11 分钟,米索前列醇 531±11 分钟,P =.009;剂量强度 - 地诺前列酮 11.3±0.1mU/分钟,米索前列醇 7.4±0.2mU/分钟,P =.003。41 例接受米索前列醇治疗的患者中有 19 例在宫颈成熟期间发动临产,而接受地诺前列酮治疗的 42 例患者中有 6 例发动临产(P =.002)。剖宫产率无差异(地诺前列酮组 8/42;米索前列醇组 9/42;P = 1.00)。短期新生儿结局无差异。在宫颈成熟期间,没有患者出现过度刺激或因胎儿评估结果不令人放心而需要剖宫产。

结论

门诊给予单次剂量的米索前列醇可显著减少缩宫素的使用,这主要归因于宫颈成熟期间发动的临产。

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