Status:
COMPLETED
Glucocorticoid Administration After Traumatic Birth
Lead Sponsor:
University of Michigan
Conditions:
Traumatic Birth
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 assessmen...
Eligibility Criteria
Inclusion
- Inclusion Criteria (for observation and hydrocortisone treatment groups):
- Screening positive for PTSD Diagnostic and Statistical Manual of Mental Disorders-5 Criteria A (felt a threat to life or injury to self or neonate)
- Postpartum hemorrhage or emergency cesarean delivery
- Owner of a smart phone or email account
- Exclusion Criteria (for observation and hydrocortisone treatment groups):
- Active uncontrolled psychological disturbances identified by current psychiatric admission
- Psychiatric consult during admission, or need for hospital appointed sitter during admission
- Non-English speakers requiring a translator
- Current corticosteroid use or corticosteroid use during the study period (including betamethasone for promoting fetal lung maturity)
- Cognitive impairment identified by medical chart review or patients requiring a legal guardian for medical decision making
- 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
Exclusion
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2022
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04852458
Start Date
May 21 2021
End Date
November 3 2022
Last Update
November 9 2022
Active Locations (1)
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1
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, United States, 48109