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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Nulliparous active labor, epidural analgesia, and cesarean delivery for dystocia.
American Journal of Obstetrics and Gynecology 1997 December
OBJECTIVE: Our purpose was to examine the effect of epidural analgesia on dystocia-related cesarean delivery in actively laboring nulliparous women.
STUDY DESIGN: Active labor was confirmed in nulliparous women by uterine contractions, cervical dilatation of 4 cm, effacement of 80%, and fetopelvic engagement. Patients were randomized to one of two groups: epidural analgesia or narcotics. A strict protocol for labor management was in place. Patients recorded the level of pain at randomization and at hourly intervals on a visual analog scale. Elective outlet operative vaginal delivery was permitted.
RESULTS: One hundred women were randomized. No difference in the rate of cesarean delivery for dystocia was noted between the groups (epidural 8%, narcotic 6%; p = 0.71). No significant differences were noted in the lengths of the first (p = 0.54) or second (p = 0.55) stages of labor or in any other time variable. Women with epidural analgesia underwent operative vaginal delivery more frequently (p = 0.004). Pain scores were equivalent at randomization, but large differences existed at each hour thereafter. The number of patients randomized did not achieve prestudy estimates. A planned interim analysis of the results demonstrated that we were unlikely to find a statistically significant difference in cesarean delivery rates in a trial of reasonable duration.
CONCLUSIONS: With strict criteria for the diagnosis of labor and with use of a rigid protocol for labor management, there was no increase in dystocia-related cesarean delivery with epidural analgesia.
STUDY DESIGN: Active labor was confirmed in nulliparous women by uterine contractions, cervical dilatation of 4 cm, effacement of 80%, and fetopelvic engagement. Patients were randomized to one of two groups: epidural analgesia or narcotics. A strict protocol for labor management was in place. Patients recorded the level of pain at randomization and at hourly intervals on a visual analog scale. Elective outlet operative vaginal delivery was permitted.
RESULTS: One hundred women were randomized. No difference in the rate of cesarean delivery for dystocia was noted between the groups (epidural 8%, narcotic 6%; p = 0.71). No significant differences were noted in the lengths of the first (p = 0.54) or second (p = 0.55) stages of labor or in any other time variable. Women with epidural analgesia underwent operative vaginal delivery more frequently (p = 0.004). Pain scores were equivalent at randomization, but large differences existed at each hour thereafter. The number of patients randomized did not achieve prestudy estimates. A planned interim analysis of the results demonstrated that we were unlikely to find a statistically significant difference in cesarean delivery rates in a trial of reasonable duration.
CONCLUSIONS: With strict criteria for the diagnosis of labor and with use of a rigid protocol for labor management, there was no increase in dystocia-related cesarean delivery with epidural analgesia.
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