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Original Investigation
June 2, 2020

Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial

Author Affiliations
  • 1Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco
  • 2Department of Epidemiology and Biostatistics, University of California, San Francisco
  • 3Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston
  • 4Marin Community Clinic, San Rafael, California
  • 5California Pacific Medical Center, San Francisco
  • 6Feinberg School of Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois
JAMA. 2020;323(21):2151-2159. doi:10.1001/jama.2020.5952
Key Points

Question  Does use of a patient-centered decision support tool increase the likelihood of trial of labor after previous cesarean delivery?

Findings  In this randomized clinical trial of 1485 women with previous cesarean delivery, use of a decision support tool compared with usual care resulted in rates of trial of labor of 43.3% vs 46.2%, a difference that was not statistically significant.

Meaning  The use of this decision support tool did not affect rates of trial of labor, but further research may be needed to assess its efficacy in other clinical settings.

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.

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