NCT04852458: 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

Outcome

Missed primary endpoint

paper In those at high risk for PTSD, glucocorticoids did not decrease, and may have increased, PTSD symptomatology. PMID 41586417 ↗

Publications

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.

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.