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

Enrolling by invitation · Not applicable

Conditions studied: Trauma, Obstetrics Trauma, Pregnancy Related

In brief

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.

Key facts

Study ID

NCT06654427

Run by

The Miriam Hospital

People needed

165

Starts

2025-07-01

Expected to finish

2027-06-30

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Patient participants will be excluded from the study interviews if they report
• a current unsafe environment (determined by the Assessment of Immediate Safety)
• report suicidal ideation (as determined by the PHQ9)
• report difficulty discussing experiences related to trauma.
• Provider participants will be excluded from the study if they do not work at one of the pilot clinics. Provider participants will be excluded from the study interviews if they do not consent to be interviewed.

Where it is running

• The Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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