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Results from the PROCEED RCT: Can a Decision Support Tool Impact Trial of Labor Choice?

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BACKGROUND AND PURPOSE:

  • Kuppermann et al. (JAMA, 2020) examined the effects of a patient-centered decision support tool on TOLAC rates and decision quality

METHODS:

  • Multicenter, randomized, parallel-group clinical trial (RCT)
    • Prior Cesarean Decision (PROCEED) trial
  • Participants
    • English- or Spanish-speaking women
    • 1 prior cesarean
    • No contraindication to trial of labor
  • Randomized 1:1 to 2 groups
    • Intervention: Tablet-based decision support tool <25 weeks | Purpose of tool is to assist women in choosing between TOLAC or repeat cesarean
    • Control: Usual care
  • Decision tool included
    • Published outcomes data related to TOLAC vs repeat cesarean
    • Preference-based predictors of TOLAC
    • Interactive multimedia decision tools
    • Integration into clinician and patient discussions to encourage shared decision-making
  • Primary outcome
    • Trial of labor
  • Secondary outcome
    • Vaginal birth
    • Maternal and neonatal outcomes
    • Decision quality

RESULTS:

  • 1470 women
    • Decision support tool: 735 women
    • Control: 735 women
    • Mean (SD) age: 34.0 (4.5) years
  • TOLAC rates did not differ significantly between groups
    • Decision support tool: 43.3%
    • Control: 46.2%
    • Adjusted absolute risk difference –2.78% (95% CI, –7.80% to 2.25%)
    • Adjusted relative risk (RR) 0.94 (95% CI, 0.84 to 1.05)
  • Vaginal birth rates did not differ significantly between intervention and control groups
    • Decision support tool: 31.8%
    • Control: 31.8%
    • Adjusted absolute risk difference –0.04% (95% CI, –4.80% to 4.71%)
    • Adjusted RR 1.00 (95% CI, 0.86 to 1.16)
  • Other clinical maternal or neonatal outcomes did not differ significantly between groups
  • There were also were no significant differences found for the 5 decision quality measures
    • Decisional conflict | Knowledge | Shared decision-making | Decision efficacy | Decision satisfaction

CONCLUSION:

  • The decision support tool, investigated in this RCT, did not appear to alter TOLAC or vaginal delivery rates
  • Authors note that

Given the high rates of trial of labor and vaginal birth and good decision quality, further increasing the trial-of-labor rate in the study population may not be appropriate or desirable, as it may already reflect the true informed preference-based demand for this delivery approach

Learn More – Primary Sources:

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


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Related ObG Topics:

VBAC Guidelines: Who is a Candidate for a Trial of Labor after Cesarean Delivery?
Trial of Labor After Cesarean for Twins and Risks for Adverse Outcomes
Three Previous Cesarean Deliveries: When to Deliver?

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