ClinConnect ClinConnect Logo
Search / Trial NCT06654427

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

Launched by THE MIRIAM HOSPITAL · Oct 21, 2024

Trial Information

Current as of August 22, 2025

Not yet recruiting

Keywords

Trauma Informed Care Obstetrics

ClinConnect Summary

The Trauma-Informed Obstetric Care trial, also known as OBTIC, is focused on creating a toolkit to help doctors and nurses provide better care for pregnant women who have experienced trauma. Many women face stress during pregnancy, especially if they have a history of traumatic experiences. This project aims to develop resources that will help healthcare providers understand and support these women, making their care more comfortable and respectful of their needs. The toolkit will include training for providers, screening tools to identify trauma, and other helpful resources.

To participate in this study, individuals need to be at least 18 years old, speak English, and be receiving care from an obstetrician or nurse practitioner in the U.S. Pregnant or postpartum women who have had at least two prenatal visits and have experienced trauma may be eligible to participate in interviews. Healthcare providers with at least six months of experience in obstetrics can also take part. Throughout the trial, participants will share their experiences to help shape the toolkit, which will be tested in two clinics before being used more broadly. This initiative seeks to ensure that all women receive compassionate and informed care during one of the most important times in their lives.

Gender

ALL

Eligibility criteria

  • Inclusion criteria for pregnant and postpartum patients for individual interviews:
  • ≥ 18 years old
  • under the care of an obstetrician or nurse practitioner in the U.S.,
  • English-speaking
  • have had ≥2 prenatal care encounters, and postpartum if they delivered a surviving infant within the past 12 months
  • received care at either of the pilot sites during the pilot trial.
  • Pregnant and postpartum participants will be eligible for the trauma-exposed group if they
  • report a history of trauma in childhood or adulthood,
  • are ≥1 year from the time of the traumatic experience
  • are not currently at-risk for harm from self or others
  • are willing to discuss experiences related to trauma and are able to do so without experiencing undue distress.
  • Patient participants will be eligible for the non-trauma group if they deny trauma.
  • Patients' stratification as White or Women of Color (any racial identity other than non-Hispanic White) will be determined by self-identification in the demographics questionnaire, rather than pre-defined groups, in order to most accurately capture participants' lived experiences.
  • Inclusion criteria for provider participants:
  • 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.
  • Exclusion Criteria:
  • 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.

About The Miriam Hospital

The Miriam Hospital, a leading academic medical center affiliated with Brown University, is dedicated to advancing healthcare through innovative clinical research and patient-centered care. Renowned for its commitment to medical excellence, the hospital conducts a wide range of clinical trials aimed at improving treatment outcomes across various specialties, including cardiology, oncology, and infectious diseases. With a focus on translating research findings into practice, The Miriam Hospital fosters collaborations among multidisciplinary teams to enhance the quality of care and promote health equity within the community and beyond.

Locations

Patients applied

0 patients applied

Trial Officials

Laura G Ward, Ph.D.

Principal Investigator

The Miriam Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported