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

Educational Objective
To learn about shared decision-making for women who may undergo a trial of labor after cesarean delivery.
1 Credit CME
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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Article Information

Corresponding Author: Miriam Kuppermann, PhD, MPH, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, 550 16th St, MH7402, San Francisco, CA 94143-0856 (miriam.kuppermann@ucsf.edu).

Accepted for Publication: April 3, 2020.

Author Contributions: Drs Kuppermann and Kaimal had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Kuppermann and Kaimal contributed equally to this article as co–first authors.

Concept and design: Kuppermann, Kaimal, Bryant, Bacchetti, Grobman.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Kuppermann, Kaimal.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Blat, Bacchetti.

Obtained funding: Kuppermann, Kaimal, Grobman.

Administrative, technical, or material support: Kuppermann, Kaimal, Grobman.

Supervision: Kuppermann, Kaimal, Altshuler, Grobman.

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.

Funding/Support: This study was supported by grant R01 HD078748 (Dr Kuppermann) from the NIH.

Role of the Funder/Sponsor: The sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Additional Contributions: We acknowledge Brittney R. Williams, MPH (Northwestern University); Allison O’Leary, MPH, Natalie Oman, MPH, and Jessica Amezcua, BA (University of California, San Francisco); Emily Behrend, MSN, CNM, and Gabriela Graciela Villaran, BS (Massachusetts General Hospital); and Carla L. Bello, BA, and Consuelo Rodriguez, BA (California Pacific Medical Center, San Francisco), all of whom served as research coordinators for the study, and Jazmin A. Fontenot, MPH (University of California, San Francisco), for assistance with data analysis and manuscript preparation. They all were funded for their work on this project by grant R01 HD078748 from the NIH. We also thank all of the women who participated in this study.

Data Sharing Statement: See Supplement 3.

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