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Completed

NCT Number: NCT04852458

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 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).

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Key information

Conditions

Traumatic Birth Birth Injuries Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(for observation and hydrocortisone treatment groups):

  • Screening positive for PTSD Diagnostic and Statistical Manual of Mental Disorders-5 Criteria A (felt a threat to life or injury to self or neonate)
  • Postpartum hemorrhage or emergency cesarean delivery
  • Owner of a smart phone or email account

Exclusion criteria

(for observation and hydrocortisone treatment groups):

  • Active uncontrolled psychological disturbances identified by current psychiatric admission
  • Psychiatric consult during admission, or need for hospital appointed sitter during admission
  • Non-English speakers requiring a translator
  • Current corticosteroid use or corticosteroid use during the study period (including betamethasone for promoting fetal lung maturity)
  • Cognitive impairment identified by medical chart review or patients requiring a legal guardian for medical decision making

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

Treatment and study plan

Intravenous (IV) hydrocortisone

Drug

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.

Other names: Solu-Cortef®

Primary outcomes

  1. PTSD assessed by the City Birth Trauma Scale

    Time frame: 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 outcomes

  1. Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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