An interventional study of Obstetric Trauma Informed Care Toolkit in Trauma, Obstetrics Trauma and Pregnancy Related, sponsored by The Miriam Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Health services research
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.
The goal of this study is to develop a stakeholder-informed toolkit for obstetric providers and patients to support the implementation of trauma-informed care (TIC) in routine clinical practice. Following interviews with providers and pregnant/postpartum participants as well as convening with a community working group of stakeholders, an OBTIC toolkit blueprint will be drafted for testing.
In the pilot implementation phase, all clinicians and administrators at an outpatient obstetrics clinic will participate in the OBTIC intervention. However, only providers who consent to participate in surveys and interviews will be contacted by the PI to complete surveys (assessment of attitudes related to TIC and usefulness of toolkit components) at the mid-point (month 2) and after completion of the pilot (month 4). Clinicians will also be interviewed as a group (physicians and nurses separately) following a staff meeting; interviews will assess perceived acceptability, feasibility, appropriateness and helpfulness of the toolkit. Additionally, 12-20 postpartum participants, who were treated at the clinic during the pilot, will be recruited for brief semi-structured qualitative interviews and surveys following the completion of the pilot. In order to assess adoption of the trauma screening component of the TIC toolkit, I will conduct chart review of initial prenatal visits at baseline (3 months prior) during (9 months of the pilot trial) and after completion (3 months following completion) of the pilot trial to assess rates of screening. To assess exploratory efficacy outcomes, I will use chart review to collect data on 1) Perinatal care: care engagement (appointment adherence, attendance of postpartum follow-up), and care choices (elective augmentation of delivery); 2) Maternal-infant outcomes: breastfeeding (initiation and continuation), infant birthweight, and post-partum pain; 3) Perinatal mental health: depression (EPDS or PHQ-9), and anxiety (GAD-7). In the sample of patients who elect to participate in interviews, I will also assess prior trauma exposure (ACE and BTQ), PTSD symptoms (PCL-5 and City Birth Trauma Scale) and experiences of discrimination and safety in care (Personal Discrimination Multi-Item Measure).
Sample sizes for the qualitative components of the study were determined in order to achieve adequate distribution to stratify by key study variables (trauma exposure, pregnancy status, provider type). For the pilot implementation trial, the aim of the quantitative aims is to generate data needed to evaluate the feasibility and acceptability of the designed intervention, and to generate estimates of key parameters (variance of outcome measures) to approach power and sample size estimation for an efficacy study.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 165 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
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Inclusion criteria for pregnant and postpartum patients for individual interviews:
Pregnant and postpartum participants will be eligible for the trauma-exposed group if they
Inclusion criteria for provider participants:
Exclusion Criteria:
Patient participants will be excluded from the study interviews if they report
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.
The OB-TIC intervention toolkit will be pilot tested in outpatient obstetrics clinics. OB-TIC will be implemented for 9 months during which time I will assess providers' and patients' perceptions of acceptability, appropriateness, and feasibility of OB-TIC. Adoption of OB-TIC, attitudes towards TIC, appointment adherence and care choices, maternal-infant health outcomes, and patient mental health will be assessed before, during, and after the pilot.
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.
Also known as: OBTIC, STAR-OB
Evaluation of intervention components for adaptation and scale-up implementation
Once the OB-TIC toolkit is complete, I will work with my mentorship team to create a survey to assess the most frequently used components of the toolkit. For example, if OB-TIC includes trauma-informed birth strategies, mental health referrals, and a modified exam procedure checklist, the survey would list each of these components and ask clinicians how often each component was used, rate how useful the component was, and whether they made changes to any of the materials.
Time frame: Surveys to evaluate specific components of the OB-TIC toolkit will be given in early implementation (2-3 months)
Evaluation of intervention components for adaptation and scale-up implementation
Once the OB-TIC toolkit is complete, I will work with my mentorship team to create a survey to assess the most frequently used components of the toolkit. For example, if OB-TIC includes trauma-informed birth strategies, mental health referrals, and a modified exam procedure checklist, the survey would list each of these components and ask clinicians how often each component was used, rate how useful the component was, and whether they made changes to any of the materials.
Time frame: Surveys to evaluate specific components of the OB-TIC toolkit will be given in sustainment (6-12 months)
Change in Acceptability of Intervention Measure
Clinicians will rate acceptability on a 5-point ordinal scale ranging from "completely disagree" to "completely agree". The measure consists of 4 items and has a test-retest reliability Cronbach alpha of .83.
Time frame: Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)
Change in Intervention Appropriateness Measure
Clinicians will rate appropriateness on a 5-point ordinal scale ranging from "completely disagree" to "completely agree". The measure consists of 4 items and has a test-retest reliability Cronbach alpha of .87.
Time frame: Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)
Change in Feasibility of Intervention Measure
Clinicians will rate feasibility on a 5-point ordinal scale ranging from "completely disagree" to "completely agree". The measure consists of 4 items and has a test-retest reliability Cronbach alpha of .88.
Time frame: Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)
Change in Patient health questionnaire (PHQ-9)
The PHQ-9 is a standardized measure of depression which has been used widely in obstetric settings. It consists of 9 questions and is scored from 0 to 3. Clinical significance is determined by a score of 5 or higher for mild depression and 10 or higher for moderate depression. The PHQ9 has an internal consistency of .89.
Time frame: The PHQ9 will be used to assess patient mood changes before (3 months prior) during (9 months) and 3 months after the pilot trial via chart review
City Birth Trauma Scale
The City Birth Trauma Scale is a 29 item scale that assesses perinatal experiences according to DSM 5 PTSD criteria. It has been shown to have reliability of .92.
Time frame: 9-12 months post-intervention
Change in Appointment Adherence
Appointment Adherence will be measured by assessing the ratio of attended to scheduled appointments. The type of appointment will also be recorded (ultrasound, initial obstetric visit, pelvic exam, medication consultation, glucose testing, etc)
Time frame: Chart review will be used to assess the change in ratio of attended to scheduled appointments before (3 months prior) during (for 9 months of implementation) and after (3 months following the 9 month implementation period) the pilot trial.
Change in Elective augmentation of delivery
Patient preferences for augmentation of delivery will be recorded via chart review and dichotomized as yes or no.
Time frame: 3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review
Change Breastfeeding frequency
Initiation and length of continuation of breastfeeding up to 6 weeks as noted at postpartum follow-up appointment.
Time frame: 3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review
Change in average infant birth-weight
Infant birthweight as recorded in delivery note in medical record.
Time frame: 3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review
Change in Post-partum pain ratings
Postpartum pain as recorded in postpartum note in medical record.
Time frame: 3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review
Change in Generalized Anxiety Disorder Assessment (GAD-7)
The GAD-7 is a self-report measure of anxiety and worry with higher scores indicating greater severity in symptoms. The GAD-7 has demonstrated excellent internal consistency and reliability (.92).
Time frame: 3 months before the pilot, during the 9 months of implementation, and 3 months after the pilot trial assessed via chart review
Posttraumatic stress disorder checklist for DSM-5 (PCL-5)
The PCL-5 is a 20 item self-report measure assessing 20 post-traumatic stress disorder symptoms according to criteria in the Diagnostic and Statistical Manual (DSM-5). It has demonstrated good internal consistency and reliability (.94). A total severity score is calculated from the sum of the responses to the 20 items.
Time frame: After completion of the pilot trial (9-12 months after the start of implementation), a subset of patients will be recruited for interviews and completion of surveys
Plan to share: No — Since the bulk of data collected for this project are qualitative data, the decision has been made not to share these data as they may be identifying of participants.
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Started Jul 2025 (actual). Primary completion is estimated for Jun 2027, 23 months after the start.
Of 546 non-industry interventional studies with no phase under Wounds and Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's planned 23 months is close to that.
Counting every sponsor, half of 599 studies reached it within 24 months; a quarter within 9 and three quarters within 48.
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