TraumaOBTICNCT06654427
Trauma-Informed Obstetric Care: Development and Implementation of a Toolkit for Obstetrics (OBTIC)
A study testing Obstetric Trauma Informed Care Toolkit in people with Trauma and Obstetrics Trauma, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Obstetrics Trauma, Pregnancy Related
- What is being tested?
- Obstetric Trauma Informed Care Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Practicing physicians or nurses
- ≥ 6 months of experience in obstetrics
- English speaking
- Clinician Participants (providers in the participating clinics) will be enrolled in the pilot trial of the obstetric trauma-informed care toolkit intervention.
- Clinician participants will be enrolled for group or individual interviews if they consent to do so and meet above criteria.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Trauma-Informed Obstetric Care: Development and Implementation of a Stakeholder- Informed Toolkit for Obstetric Providers and Patients
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.
Read the detailed description
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.
- Conditions
- Trauma, Obstetrics Trauma, Pregnancy Related
- Being tested
- Obstetric Trauma Informed Care Toolkit
- Keywords
- trauma informed care, Obstetrics
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric Trauma Informed Care ToolkitBehavioural
Also called OBTIC, STAR-OB
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.
| Study group | Role | What they receive |
|---|---|---|
| Implementation of OBTIC | Experimental | 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. Receives: Behavioral: Obstetric Trauma Informed Care Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Jul 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The OBTIC toolkit will be used in an obstetrics clinic for a 9 month period. Baseline will be evaluated 3 months pre-implementation trial and follow-up will be measured 3 months post-implementation trial.
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Responsible party
- Sponsor
- Investigators
- Laura G Ward, Ph.D., Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654427
- Sponsor's protocol ID
- K23HD107296-01A1
- Acronym
- OBTIC
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-Informed Obstetric Care: Development and Implementation of a Stakeholder- Informed Toolkit for Obstetric Providers and Patients
- ClinicalTrials.gov ID
- NCT06654427
- Acronym / sponsor ID
- OBTIC / K23HD107296-01A1
- Conditions
- Trauma, Obstetrics Trauma, Pregnancy Related
- Keywords
- trauma informed care, Obstetrics
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The OBTIC toolkit will be used in an obstetrics clinic for a 9 month period. Baseline will be evaluated 3 months pre-implementation trial and follow-up will be measured 3 months post-implementation trial.
| Arm | Type | Receives |
|---|---|---|
| Implementation of OBTIC | Experimental | Behavioral: Obstetric Trauma Informed Care ToolkitThe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Practicing physicians or nurses
- ≥ 6 months of experience in obstetrics
- English speaking
- Clinician Participants (providers in the participating clinics) will be enrolled in the pilot trial of the obstetric trauma-informed care toolkit intervention.
- Clinician participants will be enrolled for group or individual interviews if they consent to do so and meet above criteria.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetric Trauma Informed Care ToolkitAlso: OBTIC, STAR-OBThe 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. | Behavioural | Implementation of OBTIC |
Primary outcome
Evaluation of intervention components for adaptation and scale-up implementation
Time frame: Surveys to evaluate specific components of the OB-TIC toolkit will be given in early implementation (2-3 months)
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.
Evaluation of intervention components for adaptation and scale-up implementation
Time frame: Surveys to evaluate specific components of the OB-TIC toolkit will be given in sustainment (6-12 months)
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.
Change in Acceptability of Intervention Measure
Time frame: Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)
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.
Change in Intervention Appropriateness Measure
Time frame: Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)
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.
Change in Feasibility of Intervention Measure
Time frame: Clinicians are given the survey in early implementation (2-3 months) and sustainment (6-12 months)
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.
9 secondary outcomes
Change in Patient health questionnaire (PHQ-9)
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
Time frame: 9-12 months post-intervention
Change in Appointment Adherence
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
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
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
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
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)
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura G Ward, Ph.D. principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obstetric Trauma Informed Care Toolkit in people with Trauma and Obstetrics Trauma, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of intervention components for adaptation and scale-up implementation (time frame: Surveys to evaluate specific components of the OB-TIC toolkit will be given in early implementation (2-3 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.