NCT04852458

Glucocorticoid Administration After Traumatic Birth

Completed Phase 1 Last updated 9 November 2022

What this trial tests

Phase 1 trial testing Intravenous (IV) hydrocortisone in Traumatic Birth in 133 participants. Completed in 3 November 2022.

Timeline

21 May 2021

Primary endpoint
3 November 2022

3 November 2022

Quick facts

Lead sponsor	University of Michigan
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	133
Start date	21 May 2021
Primary completion	3 November 2022
Estimated completion	3 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Intravenous (IV) hydrocortisone — full drug profile →

Conditions studied

• Traumatic Birth — all drugs for Traumatic Birth →

Sponsor

University of Michigan

Who can join

18 and older, female only, with Traumatic Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Glucocorticoids after birth trauma and the associated risk of developing posttraumatic stress disorder: a non-randomized open-label pilot trial.
   Kountanis JA, Muzik M, Mentz G, Zhao X, et al · · 2025 · PMID 41586417 · DOI 10.3389/fgwh.2025.1557552