Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.
Department of Epidemiology and Biostatistics, University of California, San Francisco.
JAMA. 2020 Jun 2;323(21):2151-2159. doi: 10.1001/jama.2020.5952.
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.
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.
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).
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.
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).
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.
降低美国的剖宫产率是一个重要的公共卫生目标；尽管有证据表明剖宫产术后阴道分娩是安全的，但大多数女性都选择了计划性剖宫产。决策支持工具可能有助于提高试产率。
分析一种以患者为中心的决策支持工具对试产和剖宫产术后阴道分娩率以及决策质量的影响。
设计、地点和参与者：这是一项多中心、随机、平行组临床试验，在波士顿、芝加哥和旧金山湾区进行。共有 1485 名英语或西班牙语母语、有 1 次剖宫产史且无试产禁忌证的女性于 2016 年 1 月至 2019 年 1 月入组；2019 年 6 月完成随访。
参与者被随机分配在 25 周妊娠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（无工具）（n=743）。
主要结局是试产；阴道分娩是主要次要结局。其他次要结局侧重于母婴结局和决策质量。
在 1485 名患者（平均年龄 34.0[标准差 4.5]岁）中，1470 名（99.0%）完成了试验（随机分组各 735 名）并纳入分析。干预组和对照组的试产率无显著差异（分别为 43.3%和 46.2%；调整后的绝对风险差异为-2.78%[95%CI，-7.80%至 2.25%]；调整后的相对风险为 0.94[95%CI，0.84-1.05]）。两组阴道分娩率也无统计学差异（均为 31.8%；调整后的绝对风险差异为 0.04%[95%CI，-4.80%至 4.71%]；调整后的相对风险为 1.00[95%CI，0.86-1.16]）或其他 6 项母婴临床次要结局。干预组和对照组在 5 项决策质量测量指标上也没有显著差异（例如，决策冲突的平均得分分别为 17.2 和 17.5；调整后的平均差异为-0.38[95%CI，-1.81 至 1.05]；得分>25 被认为具有临床意义）。
在有 1 次剖宫产史的女性中，与常规护理相比，使用决策支持工具并未显著改变试产率。可能需要进一步研究来评估该工具在其他临床环境中的疗效，或在妊娠其他时间使用该工具的疗效。
