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

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Kuppermann reported receiving grants from the National Institutes of Health (NIH), the Patient-Centered Outcomes Research Institute, the March of Dimes, and the UCSF Preterm Birth Initiative funded by Mark and Lynne Benioff and the Bill & Melinda Gates Foundation. Dr Kaimal reported receiving grants from the NIH. Dr Gonzalez reported receiving grant funding from California Institute for Regenerative Medicine. Dr Altshuler reported receiving grants from the Society of Family Planning. Dr Bacchetti reported receiving grant funding from the NIH, the Bill and Melinda Gates Foundation, and amfAR, the Foundation for AIDS Research. Dr Grobman reported receiving grant funding from the NIH, the March of Dimes, and the Preeclampsia Foundation. No other disclosures were reported.

Figures

Figure.. Participant Flow in the Prior Cesarean Decision (PROCEED) Randomized Clinical Trial