Clinical trial NCT04852458: Glucocorticoid Administration After Traumatic Birth
Official title: Glucocorticoids After Traumatic Birth and the Associated Risk of Developing Posttraumatic Stress Disorder (PTSD): an Open Label Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Traumatic Birth
Keywords: Posttraumatic stress disorder
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 133
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: PTSD assessed by the City Birth Trauma Scale
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS)
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine - University of Michigan
state: Michigan
Study officials:
affiliation: Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology
name: Joanna A Kountanis, MD
role: PRINCIPAL_INVESTIGATOR
References: