Traumatic Birth
Conditions
Keywords
Posttraumatic stress disorder
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).
Interventions
DRUGIntravenous (IV) hydrocortisone
Participants (20) will be given IV hydrocortisone within 6-12 hours of the traumatic event. 90 - 150 mg. of intravenous hydrocortisone dosing regimen based on participant weight: 90mg will be administrated to participants weighing 45-59kg. 100mg will be administrated to participants weighing 60-69kg. 120mg will be administrated to participants weighing 70-89kg. 140mg will be administrated to participants weighing 90-99kg. 150mg will be administrated to participants weighing 100-120kg.
Sponsors
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There will be an observation cohort, from which individuals who can be approached within the critical time thresholds and who meet inclusion criteria will be invited to join an open label treatment arm.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD assessed by the City Birth Trauma Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS) | up to 6 weeks | This is a 10 question scale and scores can range from 0 to 30. Probable postpartum depression will be defined as a score ≥ 10 and reported as Yes or No. The scores will be compared across the two groups. |
Countries
United States
Outcome results
None listed