Glucocorticoid Administration After Traumatic Birth

• Status: Enrolling by invitation
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Hydrocortisone; Hydrocortisone hemisuccinate

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