NCT04852458

Glucocorticoid Administration After Traumatic Birth

Glucocorticoids After Traumatic Birth and the Associated Risk of Developing Posttraumatic Stress Disorder (PTSD): an Open Label Pilot Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Traumatic Birth

Interventions

Type	Name	Description
DRUG	Intravenous (IV) hydrocortisone	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.

Timeline

• Start date: 2021-05-21
• Primary completion: 2022-11-03
• Completion: 2022-11-03
• First posted: 2021-04-21
• Last updated: 2022-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study