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Trauma-Informed Obstetric Care: Development and Implementation of a Toolkit for Obstetrics (OBTIC)

Study acronym: OBTIC
StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 8 more changesShow less
    • Primary completion date: Jun 1, 2026 to Jun 1, 2027
    • Start date changed from estimate of Jan 2, 2025 to Jul 1, 2025
    • Primary endpoints: 6 to 5
    • Study sites: 0 to 1
    • Study completion date: Jun 30, 2026 to Jun 30, 2027
    • Eligibility criteria shortened, about 37 words
    • Secondary endpoints: 11 to 9
    • Study description shortened, about 5 words
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Many pregnant women have experienced trauma, which can make perinatal care stressful and increase the risk of pregnancy-related health conditions. However, obstetric providers can modify procedures to reduce distress and enhance patients' sense of control and safety. Although obstetric providers frequently care for trauma survivors, most are not trained in trauma-informed care (TIC). Additionally, there are no data on feasibility, appropriateness, or acceptability of TIC tools and interventions in the context of obstetrics. The goal of this project is to develop the first, stakeholder-informed obstetric TIC toolkit composed of treatment protocols, clinician training, trauma and violence screening tools, and other resources to help obstetric providers apply TIC practices to all clinical interactions in addition to identifying and providing support for trauma survivors. The obstetric TIC intervention toolkit (OB-TIC) will be developed in collaboration with key stakeholders (pregnant and postpartum patients, nurses, physicians, and administrators) to ensure that it is feasible, acceptable, appropriate, cost-effective, and clinically useful. Current practices and preferences will be characterized in qualitative interviews with stakeholders which will inform the development of OBTIC in collaboration with a community working group of stakeholders. A pilot implementation trial of OB-TIC will be conducted in outpatient obstetrics clinics to gather real-world data that will inform the final intervention toolkit, which will be tested on a larger scale in future studies.
Trial Details
NCT Number NCT06654427
Lead Sponsor The Miriam Hospital
Collaborators: Women and Infants Hospital of Rhode Island
Conditions
(from sponsor)
Trauma, Obstetrics Trauma, Pregnancy Related
Related terms Wounds and Injuries
Enrollment 165 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov