PROCEED trial found tool did not out-perform usual care

When women have had one Cesarean delivery, many can safely go on to have a subsequent vaginal birth, but a decision support tool designed to help them decide if a trial of labor is the right choice for them, was no more effective than usual care, according to study results published in JAMA.

“Reducing cesarean delivery rates in the U.S. 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,” wrote these researchers led by Miriam Kuppermann, PhD, MPH, of the University of California, San Francisco, San Francisco, CA.

In the randomized, multicenter, parallel-group Prior Cesarean Decision (PROCEED) study, these researchers enrolled 1,470 women (mean age: 24.0 years; 78.5% college educated; 93.5% married/partnered; 54.8% white; 80.7% privately insured) who had had one previous cesarean delivery whom they randomized to use a tablet-based decision support tool prior to 25-weeks’ gestation or usual care. The primary outcome of the study was trial of labor and its secondary outcomes included vaginal birth, maternal and neonatal outcome, and decision quality.

Among all patients, 6.1% had a vaginal delivery before cesarean delivery. Cesarean deliveries were most commonly chosen for fetal indications (49.2%) or arrest disorders (44.6%).

The decision support tool presented information about the process and potential outcomes of trial of labor after cesarean delivery and elective repeat cesarean delivery. It also provided a personalized tool to assess each patient’s likelihood of having a vaginal birth if they chose to undergo trial of labor. It was based on recommendations from the International Patient Decision Aids Standards Collaboration, and published data on the potential outcomes of trial of labor after cesarean delivery and repeat, elective cesarean delivery.

This tool was comprised of approximately 10 minutes of content, including information, engaging graphics, and user-specific risk information generated by a validated prediction calculator.

“The tool was designed to be integrated into clinical care to inform the conversations between clinicians and patients and encourage shared decision-making,” according to Kuppermann and colleagues.

In all, 44.8% of the patients underwent a trial of labor. However, researchers found no significant differences in the incidence of trial of labor between the intervention and the control groups (43.3% versus 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). Neither were there any between-group differences in the rates of vaginal births (31.8% in both groups; adjusted absolute risk difference: −0.04%; 95% CI: −4.80 to 4.71%; adjusted RR: 1.00; 95% CI: 0.86-1.16).

Researchers also measured clinical maternal and neonatal secondary outcomes, including delivery mode, major and minor maternal morbidity, and perinatal outcomes, and found no significant between-group differences. Among the five decision quality measures—assessed via low decisional conflict, similar knowledge, high decision self-efficacy, and high decisional satisfaction—there were also no significant differences, with mean decisional conflict scores of 17.2 in the intervention group compared with 17.5 in the control group (adjusted mean difference: −0.38; 95% CI: −1.81 to 1.05).

“In general, study participants had mean decisional conflict scores that were well below the threshold for clinically important decisional conflict,” noted Kuppermann and colleagues.

Study limitations include the high rate of trial of labor in both groups, the use of the decision tool before 25 week’s gestation, the inability to detect potentially clinically significant differences in outcomes with low frequencies, and the high prevalence of college educated, partnered patients being cared for in academic medical centers included in the cohort.

Rates of cesarean delivery in the United States have substantially increased in the past 50 years, according to the authors of an accompanying editorial, Geeta K. Swamy, MD, of Duke University Medical Center, and Chad A. Grotegut, MD, of Duke University, Durham, NC. However, the number of vaginal births after cesarean has also increased.

“A crucial step in the path to a successful [vaginal birth after cesarean] VBAC is a pregnant woman’s decision to attempt a [trial of labor after cesarean] TOLAC. ACOG recommends that patients be counseled about the potential risks and benefits of both TOLAC and repeat cesarean delivery. Incorporating an individuals’ characteristics to calculate the likelihood of completed VBAC can be useful to both obstetricians and patients as they discuss options and delivery planning,” they wrote.

The PROCEED study was well-designed with a rigorous protocol, yet researchers failed to find significant differences in results brought about by the use of a decision support tool, noted Swamy and Grotegut.

They added, however, that the “skewed sociodemographic and educational characteristics of the population may have contributed to the overall results of the study.”

Nevertheless, Swamy and Grotegut are hopeful that such a decision support tool may, in the future, help counsel women during pregnancy, especially those who are pregnant for the first time.

“A shared decision support tool could be quite helpful in counseling first-time pregnant women about delivery planning as well as other complex decisions during the course of maternal-fetal care,” they concluded.

  1. The use of a specially designed decision support tool did not increase the likelihood of trial of labor in women who underwent a previous cesarean delivery.

  2. Further research of such a tool as applied in other clinical settings or at other times in pregnancy are needed.

E.C. Meszaros, Contributing Writer, BreakingMED™

Kuppermann has received 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.

Swamy has served as chairman of the independent data monitoring committees for GlaxoSmithKline and Pfizer for studies centered on vaccines for respiratory syncytial virus and group B Streptococcus, respectively, in pregnant women.

This study was supported by a grant from the NIH.

Cat ID: 41

Topic ID: 83,41,730,41,192