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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous hydrocortisone | Experimental |
| |
| Observational | No Intervention | Participants will complete assessments/surveys only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria (for observation and hydrocortisone treatment groups):
Exclusion Criteria (for observation and hydrocortisone treatment groups):
Exclusion Criteria: (additional criteria for participants that will receive hydrocortisone)
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| Name | Affiliation | Role |
|---|---|---|
| Joanna A Kountanis, MD | Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine - University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41586417 | Derived | 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. |
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| ID | Term |
|---|---|
| D001720 | Birth Injuries |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014947 | Wounds and Injuries |
| D040921 | Stress Disorders, Traumatic |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| C007133 | hydrocortisone hemisuccinate |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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.
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|
|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |