Importance Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates. Objective To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality. Design, Setting, and Participants Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019. Interventions Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743). Main Outcomes and Measures The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality. Results Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important). Conclusions and Relevance Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.

中文翻译：

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以患者为中心的决策支持工具对剖宫产后试产率的影响


重要性 降低美国剖腹产率是一项重要的公共卫生目标；尽管有证据表明剖腹产后阴道分娩是安全的，但大多数妇女仍计划再次剖腹产。决策支持工具可以帮助提高试产率。目的 分析以患者为中心的决策支持工具对剖宫产后试产率和阴道分娩率以及决策质量的影响。设计、设置和参与者 在波士顿、芝加哥和旧金山湾区进行的多中心、随机、平行组临床试验。 2016 年 1 月至 2019 年 1 月期间，共有 1485 名讲英语或西班牙语的妇女入组，她们​​曾进行过 1 次剖腹产且无试产禁忌症；随访于 2019 年 6 月完成。 干预措施 参与者被随机分配在妊娠 25 周前使用基于平板电脑的决策支持工具 (n=742) 或接受常规护理（不使用该工具）(n=743)。主要成果和措施 主要成果是试产；阴道分娩是主要的次要结局。其他次要结局侧重于孕产妇和新生儿结局以及决策质量。结果 在 1485 名患者（平均年龄，34.0 [SD，4.5] 岁）中，1470 名患者 (99.0%) 完成了试验（两个随机组中 n = 735）并纳入分析。干预组和对照组之间的试产率没有显着差异（分别为 43.3% 和 46.2%；调整后的绝对风险差异，-2.78% [95% CI，-7.80% 至 2.25%]；调整后的相对风险，0.94 [95% CI，0.84-1.05]）。阴道分娩率无统计学显着差异（两组均为 31.8%；调整后绝对风险差异，-0.04% [95% CI，-4.80% 至 4.71%]；调整后相对风险，1。00 [95% CI, 0.86-1.16]）或其他 6 项临床孕产妇和新生儿次要结局中的任何一个。干预组和对照组之间的 5 项决策质量指标也没有显着差异（例如，平均决策冲突得分分别为 17.2 和 17.5；调整后的平均差为 -0.38 [95% CI，-1.81 至 1.05]；得分>25 被认为具有临床重要性）。结论和相关性 在曾进行过 1 次剖宫产的女性中，与常规护理相比，使用决策支持工具并没有显着改变试产率。可能需要进一步的研究来评估该工具在其他临床环境中或在怀孕期间其他时间实施时的功效。