Glucocorticoid Administration After Traumatic Birth
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).
Timeline
- Start
- 2021-05-21
- Primary completion
- 2022-11-03
- Completion
- 2022-11-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydrocortisone | Other / unclassified | 90 mg | Intravenous |
| Subject | Hydrocortisone | Other / unclassified | 100 mg | Intravenous |
| Subject | Hydrocortisone | Other / unclassified | 120 mg | Intravenous |
| Subject | Hydrocortisone | Other / unclassified | 140 mg | Intravenous |
| Subject | Hydrocortisone | Other / unclassified | 150 mg | Intravenous |
Indications
No indication recorded.