Traumatic BirthPhase 1NCT04852458
Glucocorticoid Administration After Traumatic Birth
A Phase 1 study testing Intravenous (IV) hydrocortisone in people with Traumatic Birth, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Traumatic Birth
- What is being tested?
- Intravenous (IV) hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 3 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: 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).
- Conditions
- Traumatic Birth
- Being tested
- Intravenous (IV) hydrocortisone
- Keywords
- Posttraumatic stress disorder
- Medical subject headings
- Birth Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous (IV) hydrocortisoneDrug
Also called Solu-Cortef®
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous hydrocortisone | Experimental | Not described Receives: Drug: Intravenous (IV) hydrocortisone |
| Observational | No intervention | Participants will complete assessments/surveys only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 weeks
Secondary outcomes (1)
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.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start21 May 2021
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic BirthStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Kountanis, University of Michigan
- Investigators
- Joanna A Kountanis, MD, Principal investigator, Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852458
- Sponsor's protocol ID
- HUM00174658
- Status last verified
- Nov 2022
- First submitted
- 16 Apr 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41586417
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoids After Traumatic Birth and the Associated Risk of Developing Posttraumatic Stress Disorder (PTSD): an Open Label Pilot Trial
- ClinicalTrials.gov ID
- NCT04852458
- Acronym / sponsor ID
- HUM00174658
- Conditions
- Traumatic Birth
- Keywords
- Posttraumatic stress disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravenous hydrocortisone | Experimental | Drug: Intravenous (IV) hydrocortisone |
| Observational | No intervention | –Participants will complete assessments/surveys only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous (IV) hydrocortisoneAlso: Solu-Cortef®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. | Drug | Intravenous hydrocortisone |
Primary outcome
PTSD assessed by the City Birth Trauma Scale
Time frame: up to 6 weeks
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.
1 secondary outcome
Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS)
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Derived from this study: PubMed 41586417Kountanis 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.
- Individual participant dataSharing planned: No
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Mandala-Based Intervention in Pregnancy
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Constraint Therapy for Brachial Plexus Birth Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna A Kountanis, MD principal investigator
Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous (IV) hydrocortisone in people with Traumatic Birth, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD assessed by the City Birth Trauma Scale (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04852458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.