Trauma-Informed Obstetric Care: Development and Implementation of a Toolkit for Obstetrics (OBTIC)
NCT06654427 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165
Last updated 2026-05-11
Summary
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.
Conditions
- Trauma
- Obstetrics Trauma
- Pregnancy Related
Interventions
- BEHAVIORAL
-
Obstetric Trauma Informed Care Toolkit
The OB-TIC toolkit will include provider and staff training on trauma- informed care and information on trauma-related perinatal concerns; trauma assessment tools; trauma-informed procedure modifications; clinical language guides; patient-facing resources including birth strategies, referral resources, and education; and clinical language. The OB-TIC intervention will utilize the toolkit to integrate trauma-informed care into clinical practice. Implementation strategies will be assessed to determine the most effective method for integrating OB-TIC content into practice.
Sponsors & Collaborators
-
Women and Infants Hospital of Rhode Island
collaborator OTHER -
The Miriam Hospital
lead OTHER
Principal Investigators
-
Laura G Ward, Ph.D. · The Miriam Hospital
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2027-06-01
- Completion
- 2027-06-30
Countries
- United States
Study Locations
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