硬膜外镇痛对剖宫产率的影响：一项随机、前瞻性临床试验。

The influence of epidural analgesia on cesarean delivery rates: a randomized, prospective clinical trial.

作者信息

Clark A, Carr D, Loyd G, Cook V, Spinnato J

机构信息

Departments of Obstetrics and Gynecology and Anesthesia, University of Louisville School of Medicine, Louisville, Kentucky, USA.

出版信息

Am J Obstet Gynecol. 1998 Dec;179(6 Pt 1):1527-33. doi: 10.1016/s0002-9378(98)70019-5.

DOI:10.1016/s0002-9378(98)70019-5

PMID:9855591

Abstract

OBJECTIVE

The effects of epidural analgesia on the progress of labor are controversial. The objective of this study was to determine the effect of epidural analgesia on cesarean delivery rates in a population of patients randomly assigned to receive either epidural analgesia or intravenous opioids for intrapartum pain relief.

STUDY DESIGN

From January 1995 to May 1996, 318 spontaneously laboring, term, nulliparous patients were randomly assigned to receive either intravenous opioids or epidural analgesia for pain relief. Labor was managed according to the principles of active management of labor. Cesarean delivery was performed for obstetric indications. Data analysis was conducted on an intent-to-treat basis. A subanalysis was subsequently performed on patients who were compliant with the allocated form of treatment.

RESULTS

One hundred sixty-two patients were randomly assigned to receive intravenous meperidine and 156 were randomly assigned to receive epidural analgesia. Maternal age, gravidity, race, gestational age, and cervical dilatation at admission and at first analgesic dose did not differ between the groups. Intent-to-treat data analysis revealed no significant difference in the cesarean delivery rate between the 2 groups, being 13.6% in the opioid group and 9.6% in the epidural group (relative risk 0.70, 95% confidence interval 0.38-1.31, P >.05). Cesarean delivery rates for the indication of dystocia also did not differ, being 10.5% in the opioid group and 5.8% in the epidural group (relative risk 0.56, 95% confidence interval 0.26-1.21, P >.05). Subanalysis of the data from patients who were compliant with the allocated form of treatment revealed that patients in the epidural group (n = 147) were 3 times more likely to have an active phase duration >/=8 hours and were 10 times more likely to require >/=2 hours in the second stage of labor than were those in the opioid group (n = 78). There were no significant differences in cesarean delivery rates in this subanalysis, being 7.7% in the opioid group and 8.8% in the epidural group (relative risk 1.15, 95% confidence interval 0.45-2.91, P >. 05). The cesarean delivery rates for dystocia were also similar in the subanalysis, being 3.8% in the opioid group and 5.5% in the epidural group (relative risk 1.42, 95% confidence interval 0.39-5. 22, P >.05).

CONCLUSION

Epidural analgesia provides safe and effective intrapartum pain control and may be administered without undesirable effects on labor outcome.

摘要

目的

硬膜外镇痛对产程的影响存在争议。本研究的目的是确定在随机分配接受硬膜外镇痛或静脉注射阿片类药物以缓解产痛的患者群体中，硬膜外镇痛对剖宫产率的影响。

研究设计

从1995年1月至1996年5月，318例自然临产、足月、初产妇被随机分配接受静脉注射阿片类药物或硬膜外镇痛以缓解疼痛。产程按照积极处理产程的原则进行管理。因产科指征行剖宫产。数据分析基于意向性治疗原则。随后对依从分配治疗方式的患者进行了亚组分析。

结果

162例患者被随机分配接受静脉注射哌替啶，156例被随机分配接受硬膜外镇痛。两组患者的产妇年龄、孕次、种族、孕周以及入院时和首次镇痛时的宫颈扩张情况无差异。意向性治疗数据分析显示两组剖宫产率无显著差异，阿片类药物组为13.6%，硬膜外组为9.6%（相对危险度0.70，95%可信区间0.38 - 1.31，P>.05）。难产指征的剖宫产率也无差异，阿片类药物组为10.5%，硬膜外组为5.8%（相对危险度0.56，95%可信区间0.26 - 1.21，P>.05）。对依从分配治疗方式的患者数据进行亚组分析显示，硬膜外组（n = 147）活跃期持续时间≥8小时的可能性是阿片类药物组（n = 78）的3倍，第二产程需要≥2小时的可能性是阿片类药物组的10倍。该亚组分析中剖宫产率无显著差异，阿片类药物组为7.7%，硬膜外组为8.8%（相对危险度1.15，95%可信区间0.45 - 2.91，P>.05）。亚组分析中难产的剖宫产率也相似，阿片类药物组为3.8%，硬膜外组为5.5%（相对危险度1.42，95%可信区间0.39 - 5.22，P>.05）。