Glucocorticoid Administration After Traumatic Birth

Glucocorticoids After Traumatic Birth and the Associated Risk of Developing Posttraumatic Stress Disorder (PTSD): an Open Label Pilot Trial

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).

Study Overview

• Status: Completed
• Conditions: Traumatic Birth
• Intervention / Treatment: Drug: Intravenous (IV) hydrocortisone

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Michigan Medicine - University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous hydrocortisone	Drug: Intravenous (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.; Other Names: Solu-Cortef®
No Intervention: Observational; Participants will complete assessments/surveys only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS)	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.	up to 6 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Joanna A Kountanis, MD, Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): November 3, 2022

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Posttraumatic stress disorder
• Additional Relevant MeSH Terms: Wounds and Injuries; Infant, Newborn, Diseases; Birth Injuries; Anti-Inflammatory Agents; Hydrocortisone; Hydrocortisone hemisuccinate
• Other Study ID Numbers: HUM00174658

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No