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A Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia

Study acronym: PrepDM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Dec 2026 → Jun 2027
See other at-risk trials from Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 4 more changesShow less
    • Primary and study completion pushed from Dec 2026 to Jun 2027
    • Start date changed from estimate of Apr 2026 to Jul 15, 2026
    • Eligibility criteria expanded, about 7 words
    • Site details revised
  2. Interventions: Preparation for Decision Making (PrepDM) Scale (Other) to Preparation for Decision Making (PrepDM) Scale (Other), Questionnaire (Other)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study title shortened, about 5 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Labour analgesia decisions are often made under time pressure, while in pain, which may lead patients to feel unprepared or uninformed. Shared decision-making (SDM) enhances patient satisfaction, promotes alignment with personal values, and improves trust in clinical care. Digital tools can support SDM by providing accessible, evidence-based information. The Society for Obstetric Anesthesia and Perinatology (SOAP) is an international organization made up of doctors who specialize in managing pain and anesthesia during pregnancy. Their focus is the wellbeing and safety of mothers and their babies from early pregnancy through delivery and recovery. The Painless Push digital resource educates mothers about ways to manage pain during labour. This trial aims to evaluate whether directing patients to access to the website https://thepainlesspush.com/ improves preparedness for shared decision-making compared to the current care, which is access to the Mount Sinai Obstetric Anesthesia website.
Trial Details
NCT Number NCT07516171
Lead Sponsor Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions
(from sponsor)		 Labour Analgesia
Related terms Labor Pain
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov