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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: Completed Phase 1 study of Traumatic Birth, sponsored by University of Michigan.
NCT04852458 is a Phase 1 study of Traumatic Birth that has completed, run by University of Michigan. The registered enrollment target is 133 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (122% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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.
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 |
What the finished NCT04852458 record still lists
NCT04852458 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (122% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04852458's enrollment target sits among peer trials
133 432nd of 2000 higher than 1,569 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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