Department of Obstetrics and Gynecology, School of Medicine, Washington University in St Louis, St Louis, Missouri.
Department of Obstetrics and Gynecology, Perelman School of Medicine, Maternal and Child Health Research Center, University of Pennsylvania, Philadelphia.
JAMA. 2018 Oct 9;320(14):1444-1454. doi: 10.1001/jama.2018.13986.
It is unclear whether the timing of second stage pushing efforts affects spontaneous vaginal delivery rates and reduces morbidities.
To evaluate whether immediate or delayed pushing results in higher rates of spontaneous vaginal delivery and lower rates of maternal and neonatal morbidities.
DESIGN, SETTING, AND PARTICIPANTS: Pragmatic randomized clinical trial of nulliparous women at or beyond 37 weeks' gestation admitted for spontaneous or induced labor with neuraxial analgesia between May 2014 and December 2017 at 6 US medical centers. The interim analysis suggested futility for the primary outcome and recruitment was terminated with 2414 of 3184 planned participants. Follow-up ended January 4, 2018.
Randomization occurred when participants reached complete cervical dilation. Immediate group participants (n = 1200) began pushing immediately. Delayed group participants (n = 1204) were instructed to wait 60 minutes.
The primary outcome was spontaneous vaginal delivery. Secondary outcomes included total duration of the second stage, duration of active pushing, operative vaginal delivery, cesarean delivery, postpartum hemorrhage, chorioamnionitis, endometritis, perineal lacerations (≥second degree), and a composite outcome of neonatal morbidity that included neonatal death and 9 other adverse outcomes.
Among 2414 women randomized (mean age, 26.5 years), 2404 (99.6%) completed the trial. The rate of spontaneous vaginal delivery was 85.9% in the immediate group vs 86.5% in the delayed group, and was not significantly different (absolute difference, -0.6% [95% CI, -3.4% to 2.1%]; relative risk, 0.99 [95% CI, 0.96 to 1.03]). There was no significant difference in 5 of the 9 prespecified secondary outcomes reported, including the composite outcome of neonatal morbidity (7.3% for the immediate group vs 8.9% for the delayed group; between-group difference, -1.6% [95% CI, -3.8% to 0.5%]) and perineal lacerations (45.9% vs 46.4%, respectively; between-group difference, -0.4% [95% CI, -4.4% to 3.6%]). The immediate group had significantly shorter mean duration of the second stage compared with the delayed group (102.4 vs 134.2 minutes, respectively; mean difference, -31.8 minutes [95% CI, -36.7 to -26.9], P < .001), despite a significantly longer mean duration of active pushing (83.7 vs 74.5 minutes; mean difference, 9.2 minutes [95% CI, 5.8 to 12.6], P < .001), lower rates of chorioamnionitis (6.7% vs 9.1%; between-group difference, -2.5% [95% CI, -4.6% to -0.3%], P = .005), and fewer postpartum hemorrhages (2.3% vs 4.0%; between-group difference, -1.7% [95% CI, -3.1% to -0.4%], P = .03).
Among nulliparous women receiving neuraxial anesthesia, the timing of second stage pushing efforts did not affect the rate of spontaneous vaginal delivery. These findings may help inform decisions about the preferred timing of second stage pushing efforts, when considered with other maternal and neonatal outcomes.
ClinicalTrials.gov Identifier: NCT02137200.
目前尚不清楚第二产程用力的时机是否会影响自然分娩率并降低母婴发病率。
评估立即用力与延迟用力是否会导致更高的自然分娩率和更低的产妇和新生儿发病率。
设计、地点和参与者:这是一项在 2014 年 5 月至 2017 年 12 月期间在美国 6 家医疗中心进行的、针对接受硬膜外或蛛网膜下腔麻醉的足月或近足月自发性或诱导性分娩的初产妇的实用随机临床试验。中期分析表明主要结局无统计学意义,故在计划入组的 3184 名产妇中,入组 2414 名后即终止了招募。随访于 2018 年 1 月 4 日结束。
当产妇达到完全宫颈扩张时进行随机分组。立即组(n = 1200)产妇立即开始用力,延迟组(n = 1204)产妇则被要求等待 60 分钟。
主要结局为自然分娩。次要结局包括第二产程总时长、主动用力时长、经阴道分娩、剖宫产、产后出血、绒毛膜羊膜炎、子宫内膜炎、会阴裂伤(≥Ⅱ度)以及包括新生儿死亡和其他 9 种不良结局在内的新生儿发病率的复合结局。
在随机分配的 2414 名产妇中(平均年龄 26.5 岁),2404 名(99.6%)完成了试验。立即组的自然分娩率为 85.9%,延迟组为 86.5%,两组间无显著差异(绝对差值,-0.6%[95%CI,-3.4%至 2.1%];相对风险,0.99[95%CI,0.96 至 1.03])。9 项预设的次要结局中,有 5 项无显著差异,包括新生儿发病率的复合结局(立即组为 7.3%,延迟组为 8.9%;组间差异,-1.6%[95%CI,-3.8%至 0.5%])和会阴裂伤(分别为 45.9%和 46.4%;组间差异,-0.4%[95%CI,-4.4%至 3.6%])。与延迟组相比,立即组的第二产程总时长明显更短(分别为 102.4 分钟和 134.2 分钟;平均差值,-31.8 分钟[95%CI,-36.7 至-26.9],P < .001),尽管其主动用力时长明显更长(分别为 83.7 分钟和 74.5 分钟;平均差值,9.2 分钟[95%CI,5.8 至 12.6],P < .001),绒毛膜羊膜炎发生率更低(分别为 6.7%和 9.1%;组间差异,-2.5%[95%CI,-4.6%至-0.3%],P = .005),产后出血量更少(分别为 2.3%和 4.0%;组间差异,-1.7%[95%CI,-3.1%至-0.4%],P = .03)。
在接受硬膜外麻醉的初产妇中,第二产程用力的时机并不影响自然分娩率。这些发现可能有助于在考虑其他母婴结局的情况下,为第二产程用力时机的选择提供参考。
ClinicalTrials.gov 标识符:NCT02137200。