Glucocorticoid Administration After Traumatic Birth

Phase 1

Completed

• Conditions: Traumatic Birth
• Interventions: Drug: Intravenous (IV) hydrocortisone

• Registration Number: NCT04852458
• Lead Sponsor: University of Michigan

Brief 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).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Study Start: 2021-05-21
• Status Verified: 2022-11
• Primary Completion: 2022-11-03
• Study Completion: 2022-11-03
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 133

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

(additional criteria for participants that will receive hydrocortisone)

• Self-reported hypersensitivity to hydrocortisone
• Inability to consent patient and administer study drug within 12 hours of a traumatic event
• Weight < 45 kilograms (kg) or >120kg
• Subjects with systemic active infections (e.g. viral, bacterial, fungal, protozoan, or helminthic)
• Subjects with uncontrolled hypertension, renal insufficiency, or decompensated congestive heart failure
• Subjects with inflammatory bowel disease
• Subjects with active or latent peptic ulcers

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous hydrocortisone	Intravenous (IV) hydrocortisone	-

Primary Outcome Measures

Name	Time	Method
PTSD assessed by the City Birth Trauma Scale	up to 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS)	up to 6 weeks	This is a 10 question scale and scores can range from 0 to 30. Probable postpartum depression will be defined as a score ≥ 10 and reported as Yes or No. The scores will be compared across the two groups.

Trial Locations

Locations (1)

Michigan Medicine - University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States