美国西北大学William A. Grobman联合加州大学Miriam Kuppermann团队分析了使用以患者为中心的决策支持工具对头胎剖宫产女性阴道试产的影响。2020年6月2日，该研究发表在《美国医学会杂志》上。
Title: Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial
Author: Miriam Kuppermann, Anjali J. Kaimal, Cinthia Blat, Juan Gonzalez, Mari-Paule Thiet, Yamilee Bermingham, Anna L. Altshuler, Allison S. Bryant, Peter Bacchetti, William A. Grobman
Abstract: 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.