Glucocorticoids After Traumatic Birth and the Associated Risk of Developing Posttraumatic Stress Disorder (PTSD): an Open Label Pilot Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- PTSD assessed by the City Birth Trauma Scale
Study Overview
Brief Summary
This study has two components, an observational and a trial component. The observational part is being done to screen for postpartum posttraumatic stress disorder by collecting mental health assessments in women who are immediately postpartum for up to 6 weeks.
Additionally, the project has a small number of subjects that will participate in a clinical trial in which they would self-select to receive one dose of hydrocortisone intravenously while they are in the hospital. This pilot of up to 20 participants in the trial arm is designed to create a first indication of whether this could become an effective early intervention to prevent PTSD if given while trauma memories are first being formed.
This registration will list the observational part (number of participants =100) as well as the clinical trial (number of participants =20).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(additional criteria for participants that will receive hydrocortisone)
- •Self-reported hypersensitivity to hydrocortisone
- •Inability to consent patient and administer study drug within 12 hours of a traumatic event
- •Weight < 45 kilograms (kg) or >120kg
- •Subjects with systemic active infections (e.g. viral, bacterial, fungal, protozoan, or helminthic)
- •Subjects with uncontrolled hypertension, renal insufficiency, or decompensated congestive heart failure
- •Subjects with inflammatory bowel disease
- •Subjects with active or latent peptic ulcers
Arms & Interventions
Intravenous hydrocortisone
Intervention: Intravenous (IV) hydrocortisone (Drug)
Outcomes
Primary Outcomes
PTSD assessed by the City Birth Trauma Scale
Time Frame: up to 6 weeks
This is a 29 question scale that can range from 0 to 60 (a higher score indicates greater severity of symptoms of PTSD). The response scale for symptoms asks for frequency of symptoms over the last week and is scored on a scale ranging from 0 ("not at all") to 3 ("5 or more times"). The distribution of PTSD scores will be compared between the hydrocortisone group and matched controls using appropriate statistical techniques.
Secondary Outcomes
- Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS)(up to 6 weeks)
Investigators
Joanna Kountanis
Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology
University of Michigan