Glucocorticoid Administration After Traumatic Birth

NCT04852458 | Completed Phase 1 FDA Drug

• 1 other identifier: HUM00174658
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Birth

Keywords

Posttraumatic stress disorder

Outcome Measures

Primary Outcomes (1)

• PTSD assessed by the City Birth Trauma Scale

  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.

  up to 6 weeks

Secondary Outcomes (1)

• Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS)

  up to 6 weeks

Study Arms (2)

Intravenous hydrocortisone

EXPERIMENTAL

Drug: Intravenous (IV) hydrocortisone

Observational

NO INTERVENTION

Participants will complete assessments/surveys only.

Interventions

Intravenous (IV) hydrocortisone DRUG

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.

Also known as: Solu-Cortef®

Intravenous hydrocortisone

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Kountanis JA, Muzik M, Mentz G, Zhao X, Vlisides PE. Glucocorticoids after birth trauma and the associated risk of developing posttraumatic stress disorder: a non-randomized open-label pilot trial. Front Glob Womens Health. 2026 Jan 9;6:1557552. doi: 10.3389/fgwh.2025.1557552. eCollection 2025.

  PMID: 41586417 DERIVED

MeSH Terms

Conditions

Birth Injuries; Stress Disorders, Post-Traumatic

Interventions

Hydrocortisone; hydrocortisone hemisuccinate

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Joanna A Kountanis, MD

  Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: May 21, 2021
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)