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NCT04852458 · ClinicalTrials.gov registry record · Phase 1
Glucocorticoid Administration After Traumatic Birth
A Phase 1 study of Traumatic Birth, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 133
- Enrollment target
- 1
- Study location
NCT04852458 is a Phase 1 study of Traumatic Birth that has completed, run by University of Michigan. The registered enrollment target is 133 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04852458, a Phase 1 study of Traumatic Birth, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 133 participants
- Enrollment target
- 1
- Study location
Study 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).
Conditions Studied
Interventions
- DRUG Intravenous (IV) hydrocortisone
Study Locations (1)
Michigan
- Michigan Medicine - University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2021-05-21 |
| Est. Completion | 2022-11-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04852458
The ClinicalTrials.gov registry entry for NCT04852458 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Traumatic Birth appearing as the primary indexed condition, and to 1 intervention - of which Intravenous (IV) hydrocortisone is the first listed.
NCT04852458 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT04852458 about?
NCT04852458 is a clinical study titled "Glucocorticoid Administration After Traumatic Birth". 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...
What is the current status of trial NCT04852458?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 133 participants. The study started on 2021-05-21. Estimated completion is 2022-11-03.
What conditions does trial NCT04852458 study?
This clinical trial studies the following conditions: Traumatic Birth.
What interventions are being tested in trial NCT04852458?
The interventions under investigation include: Intravenous (IV) hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT04852458?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04852458 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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