Effect of a patient-centered decision support tool on rates of trial of labor after previous cesarean delivery: The PROCEED randomized clinical trial

Reducing cesarean delivery rates is an important health goal, given its association with maternal morbidity: as cesarean delivery rates increase, so does maternal morbidity. Contributing to the rising rate of cesarean delivery is the less frequent use of the trial-of-labor approach among pregnant women after previous cesarean delivery. Consequently, vaginal birth rates after cesarean delivery have also declined. One solution may be a patient-centered, decision support tool to assist pregnant women in making informed decisions about their approach to delivery after previous cesarean delivery. The aim of this study was to assess whether a decision support tool increases the likelihood of a pregnant women opting for a trial-of-labor approach, having a vaginal birth, and experiencing good decision quality. The Prior Cesarean Decision (PROCEED) trial was a randomized, parallel-group study conducted at 3 academic medical centers and 2 community sites located in Boston, Chicago, San Francisco, California, and San Rafael, California. Singleton pregnancies with a gestational age between 12 weeks 0 days and 24 weeks 6 days were included in the study if the pregnant woman had 1 previous cesarean delivery, had not had a vaginal birth after cesarean delivery, and had no contraindications for trial of labor. After providing informed consent and completing a questionnaire, eligible participants were randomized to use the PROCEED Decision Support Tool on an electronic tablet (intervention group) or receive usual care, including clinician counseling about the delivery approach, without the use of the tool (control group). Enrollment took place from January 2016 through January 2019, with follow-up until June 2019. A total of 1470 women were included in the analysis, with 735 women in each group. Overall, the trial-of-labor approach was used by 44.8% of women. The rate of trial of labor was not statistically significant between the intervention group and control group (43.3% vs 46.2%, respectively; adjusted absolute risk difference, −2.78% [95% confidence interval (CI), −7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). Vaginal birth rates were also not statistically significant (31.8% for 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]). In addition, there were no statistically significant differences between the 2 groups on maternal outcomes, such major or minor maternal morbidity or third- or fourth-degree lacerations, or perinatal outcomes, such as perinatal death, respiratory morbidity, or admission to the neonatal intensive care unit. Similarly, there were no statistically significant differences between the groups in 5 decision quality measures, including mean scores for knowledge, shared decision-making, decision self-efficacy, decision satisfaction, and decisional conflict. For example, the mean knowledge scores were the same in both groups (5.0), and the mean decisional conflict score was 17.2 in the intervention group and 17.5 in the control group (adjusted mean difference, −0.38; 95% CI, −1.81 to 1.05). The decision support tool had no statistically significant impact on the rates of trial of labor, vaginal delivery, and decision quality among women with a previous cesarean delivery. In this study, regardless of intervention with the tool, participants experienced high trial-of-labor rates and vaginal birth rates, as well as good decision quality.