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Corticosteroid
Intravenous (IV) hydrocortisone for Birth Trauma
Phase 1
Waitlist Available
Led By Joanna A Kountanis, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights
Study Summary
This trial is studying whether a single dose of hydrocortisone given immediately postpartum can prevent post-traumatic stress disorder.
Eligible Conditions
- Birth Trauma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PTSD assessed by the City Birth Trauma Scale
Secondary outcome measures
Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous hydrocortisoneExperimental Treatment1 Intervention
Group II: ObservationalActive Control1 Intervention
Participants will complete assessments/surveys only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intravenous (IV) hydrocortisone
2021
Completed Phase 1
~140
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,925 Total Patients Enrolled
Joanna A Kountanis, MDPrincipal InvestigatorAssistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology
Frequently Asked Questions
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