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Glucocorticoid Administration After Traumatic Birth

Primary Purpose

Traumatic Birth

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intravenous (IV) hydrocortisone
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Birth focused on measuring Posttraumatic stress disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Michigan Medicine - University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intravenous hydrocortisone

Observational

Arm Description

Participants will complete assessments/surveys only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 16, 2021
Last Updated
November 8, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04852458
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
November 3, 2022 (Actual)
Study Completion Date
November 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Birth
Keywords
Posttraumatic stress disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous hydrocortisone
Arm Type
Experimental
Arm Title
Observational
Arm Type
No Intervention
Arm Description
Participants will complete assessments/surveys only.
Intervention Type
Drug
Intervention Name(s)
Intravenous (IV) hydrocortisone
Other Intervention Name(s)
Solu-Cortef®
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD assessed by the City Birth Trauma Scale
Description
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.
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS)
Description
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.
Time Frame
up to 6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna A Kountanis, MD
Organizational Affiliation
Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Medicine - University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Glucocorticoid Administration After Traumatic Birth

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