Trauma-Informed Care for Pregnancy
(OBTIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to make prenatal and postpartum care less stressful for women who have experienced trauma. Researchers are developing and testing an Obstetric Trauma Informed Care Toolkit to help healthcare providers implement trauma-informed care, tailoring their approach to be more sensitive and supportive. The goal is to ensure women feel safe and in control during appointments, potentially leading to better health outcomes for both mothers and babies. Pregnant or postpartum women who have experienced trauma and are currently receiving obstetric care in the U.S. might be suitable candidates for this trial. As an unphased study, this trial offers participants a unique opportunity to contribute to pioneering research that seeks to improve care for women who have experienced trauma.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that this obstetric trauma-informed care toolkit is safe for pregnant women?
Research shows that trauma-informed care (TIC) helps pregnant women who have experienced trauma feel safer and more in control during medical visits. The Obstetric Trauma Informed Care Toolkit (OB-TIC) supports this approach in pregnancy care.
While specific data on the safety of the OB-TIC is not yet available, trauma-informed care practices are generally well-received. These practices aim to reduce stress and improve the mental health of those who have experienced trauma. Studies have found that when healthcare providers use TIC, patients often feel more respected and understood, leading to better health outcomes and a more positive experience during pregnancy and childbirth.
Overall, the OB-TIC aims to make healthcare settings more supportive for pregnant women with trauma histories. Although the toolkit is still being tested, the approach has proven safe and helpful in other areas of healthcare.12345Why are researchers excited about this trial?
Researchers are excited about the Trauma-Informed Care for Pregnancy trial because it introduces an innovative approach with the Obstetric Trauma Informed Care (OB-TIC) Toolkit. Unlike standard obstetric care, which often doesn't specifically address trauma, OB-TIC is designed to be sensitive to the unique psychological needs of pregnant patients who have experienced trauma. This toolkit is being tested for its acceptability, appropriateness, and feasibility in outpatient settings. By focusing on trauma-informed care, the hope is to improve patient satisfaction, adherence to medical appointments, and ultimately enhance maternal and infant health outcomes.
What evidence suggests that the Obstetric Trauma Informed Care Toolkit is effective for improving perinatal care?
Research has shown that trauma-informed care can significantly improve health outcomes for pregnant women who have experienced trauma. Studies indicate that this care can reduce the risk of mental health issues, high blood pressure, early birth, and posttraumatic stress disorder. Early implementation of trauma-informed care in pregnancy has boosted patient satisfaction and involvement. Dr. Nicole Rankins, an OB-GYN, highlights that empowering women during childbirth leads to better experiences and outcomes. Additionally, psychological support during pregnancy is crucial for a positive birth experience. This trial will implement the Obstetric Trauma Informed Care Toolkit in outpatient obstetrics clinics to assess its impact on care and health outcomes for both mothers and babies.13567
Who Is on the Research Team?
Laura G Ward, Ph.D.
Principal Investigator
The Miriam Hospital
Are You a Good Fit for This Trial?
This trial is for English-speaking pregnant or postpartum women in the U.S. who have had at least two prenatal visits, delivered a surviving baby within the past year, received care at pilot sites, and have a history of trauma (at least one year ago). Participants must not be currently at risk of harm and should feel comfortable discussing their trauma.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pilot Implementation
The OB-TIC intervention toolkit is pilot tested in outpatient obstetrics clinics. Providers and patients' perceptions of acceptability, appropriateness, and feasibility of OB-TIC are assessed.
Follow-up
Participants are monitored for safety and effectiveness after the pilot implementation. Data on maternal-infant health outcomes and patient mental health are collected.
Sustainment
Surveys to evaluate specific components of the OB-TIC toolkit are conducted to assess the most frequently used components and their usefulness.
What Are the Treatments Tested in This Trial?
Interventions
- Obstetric Trauma Informed Care Toolkit
Trial Overview
The study is testing a new toolkit designed to help obstetric providers give better care to patients with past trauma. The toolkit includes training, screening tools, and support resources. It will first be tried out in outpatient clinics to see if it works well before being used more widely.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Miriam Hospital
Lead Sponsor
Women and Infants Hospital of Rhode Island
Collaborator
Citations
Trauma-Informed Obstetric Care: Development and ...
To assess exploratory efficacy outcomes, I will use chart review to collect data on 1) Perinatal care: care engagement (appointment adherence, attendance of ...
A Community-Based Trauma-Informed Care Curriculum on ...
In the perinatal context, trauma history elevates risks of mental health disorders, high blood pressure, preterm birth, and posttraumatic stress disorder. These ...
Leveraging Tools for Trauma-Informed, Respectful ...
Dr. Nicole Rankins, a seasoned OB-GYN, shares her insights on empowering women during childbirth, particularly in hospital settings.
Culturally responsive, trauma-informed, continuity of care(r ...
This scoping review identified 13 existing toolkits pertaining to culturally responsive, trauma-informed or continuity of care(r) models of care in the ...
Statement on Providing Psychological Support for Obstetric ...
This statement highlights the importance of providing psychological support to obstetric patients, a key aspect of a positive birth experience.
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ctv.veeva.com
ctv.veeva.com/study/trauma-informed-obstetric-care-development-and-implementation-of-a-toolkit-for-obstetrics-obticTrauma-Informed Obstetric Care - ClinicalTrials.Veeva
The goal of this study is to develop a stakeholder-informed toolkit for obstetric providers and patients to support the implementation of trauma ...
Supporting Families Through Pregnancy and Beyond
This toolkit brings together trusted resources to support trauma-informed care practices in maternal and infant health. It is designed to help professionals ...
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