Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial
Open accessAbstract
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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RCT results focused on the implementation of a decision aid among patients with a history of cesarean delivery found that the use of the decision aid was not substantially associated with decision quality regarding the mode of delivery, nor with clinical outcomes.
“RCT results focused on the implementation of a decision aid among patients with a history of cesarean delivery found that the use of the decision aid was not substantially associated with decision quality regarding the mode of delivery, nor with clinical outcomes.54”
From Guidelines for antenatal and preoperative care in cesarean delivery: Enhanced Recovery After Surgery Society recommendations (part 1)—2025 update (2026) · cites this paper as [54]
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- Authors
- Kuppermann, M., Kaimal, A. J., Blat, C., Gonzalez, J., Thiet, M.-P., Bermingham, Y., Altshuler, A. L., Bryant, A. S., Bacchetti, P., & Grobman, W. A.
- Affiliations
- University of California, San Francisco (US)
- Massachusetts General Hospital (US)
- Marin Community Clinic, San Rafael, California
- California Pacific Medical Center (US)
- Northwestern University (US)
- Corresponding author
- Kuppermann, Miriam
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2020-06-02
- Volume
- 323
- Issue
- 21
- Pages
- 2151
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC7267848
- OpenAlex
- W3029359439
- Cited by
- 50
- References
- 42
- Citations by year
- 2026: 4 · 2025: 8 · 2024: 9 · 2023: 6 · 2022: 8 · 2021: 12 · 2020: 2 · 2019: 1
- FWCI
- 4.28
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD078748)
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Maternal and Perinatal Health Interventions
- Health Sciences › Health Professions › General Health Professions › Patient-Provider Communication in Healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
- Keywords
- trial of labor after cesarean, vaginal birth after cesarean, decision support system, patient-centered care, decisional conflict, shared decision-making, repeat cesarean section, maternal and neonatal outcomes, Spanish-speaking women, low-income women, cesarean section rate, decision quality
- MeSH terms
- Adult, Cesarean Section, Computers, Decision Making, Decision Support Techniques, Female, Humans, Patient Participation, Pregnancy, Surveys and Questionnaires, Trial of Labor, Vaginal Birth after Cesarean, Patient-Centered Care
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