Intravenous (IV) hydrocortisone for Traumatic Birth

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Michigan Medicine - University of Michigan, Ann Arbor, MI
Traumatic Birth+1 More
Intravenous (IV) hydrocortisone - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether hydrocortisone might prevent postpartum posttraumatic stress disorder.

See full description

Eligible Conditions

  • Traumatic Birth

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Intravenous (IV) hydrocortisone will improve 1 primary outcome and 1 secondary outcome in patients with Traumatic Birth. Measurement will happen over the course of up to 6 weeks.

up to 6 weeks
Mean depression scores assessed by the Edinburgh Postnatal Depression Scale19 (EPDS)
PTSD assessed by the City Birth Trauma Scale

Trial Safety

Trial Design

2 Treatment Groups

Observational
1 of 2
Intravenous hydrocortisone
1 of 2
Active Control
Experimental Treatment

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Intravenous (IV) Hydrocortisone is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Intravenous hydrocortisone
Drug
ObservationalParticipants will complete assessments/surveys only.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 weeks for reporting.

Who is running the study

Principal Investigator
J. K.
Prof. Joanna Kountanis, Assistant Professor of Anesthesiology and Assistant Professor of Obstetrics and Gynecology
University of Michigan

Closest Location

Michigan Medicine - University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What are the common side effects of intravenous (iv) hydrocortisone?

"The most common side effects of iv hydrocortisone were mild but bothersome and must be taken into account in the long term care of the elderly." - Anonymous Online Contributor

Unverified Answer

How many people get birth injuries a year in the United States?

"The annual incidence of birth injuries is about 11/10,000 live births. This incidence is lower than the incidence of disability related injuries. Birth injuries are common and are costly to consumers and insurers." - Anonymous Online Contributor

Unverified Answer

Can birth injuries be cured?

"Trauma specialists can have a positive effect on reducing the incidence of postnatal traumatic stress disorder, and with proper interventions can be effective at preventing, treating, and curing postnatal traumatic stress." - Anonymous Online Contributor

Unverified Answer

What are the signs of birth injuries?

"Data from a recent study, we found that one of the most effective ways of recognising birth injuries is physical signs such as skin changes. The medical history and signs seen at examination are also important when diagnosing birth injuries. The presence of more than one abnormality is best recognised when all signs of an injury are present." - Anonymous Online Contributor

Unverified Answer

What causes birth injuries?

"The major causes of birth injuries in our country are related to the baby's behavior or improper hygiene, so we can help families prepare for delivery through information and education about potential birth injuries." - Anonymous Online Contributor

Unverified Answer

What is birth injuries?

"Birth injuries can be categorized into four major types: blunt trauma, fractures, perinatal/in utero trauma and peri-partum/post-partum trauma. In the USA up to 37,000 people suffer birth injuries each year, representing an estimated cost of $150-250 billion to society. Perinatal/in utero/early life and post-prandial/early morning injuries are the most frequent type of birth injuries." - Anonymous Online Contributor

Unverified Answer

What are common treatments for birth injuries?

"Most birth injuries are managed with bed rest and avoidance of physical contact to prevent further injury. Fewer injuries are managed by surgery. Only 20% are diagnosed and treated prior to discharge from the hospital or long-term care setting. The need for interventions in the neonatal intensive care unit (NICU) for more severe injuries is high. The use of steroids in premature infants may contribute to long-term neurological or cardiac problems." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for birth injuries?

"We recommend clinical trials as good places for research and care for newborns and their families, but the availability of clinical trial funding should be increased to enable the necessary level of funding for clinical research on birth injuries. Also, we need more information on the needs of mothers and families." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in intravenous (iv) hydrocortisone for therapeutic use?

"The development of hydrocortisone injections has progressed. The most common indications have been for the treatment of adrenal insufficiency, and the only common adverse reactions (>2%) reported were hypotension and hypotension-related events (such as tachycardia, sinus bradycardia), which are commonly associated with adrenal insufficiency." - Anonymous Online Contributor

Unverified Answer

What does intravenous (iv) hydrocortisone usually treat?

"There are several possible explanations for this apparent paradox. First, a significant proportion of patients with SJS who receive hydrocortisone for the long term might never develop significant systemic involvement. A recent study demonstrated that a majority of patients who received hydrocortisone for three or more weeks before the onset of the SJS or TEN phenotype continued to have a persistent rash until three or more months after treatment. Second, the clinical characteristics of individuals with SJS can be similar to those of those with TEN. Third, the use of hydrocortisone for three or more weeks may actually trigger a worsening of the disease." - Anonymous Online Contributor

Unverified Answer

Is intravenous (iv) hydrocortisone safe for people?

"It was concluded that this treatment could be administered safely in emergency departments. A more stringent criteria might be required for children for IV HC administration." - Anonymous Online Contributor

Unverified Answer

How does intravenous (iv) hydrocortisone work?

"Hydrocortisone reduces the incidence of severe birth injury. An increasing number of patients are receiving hydrocortisone, so these findings must be reproduced in other clinics. Randomized trials are needed to examine the longer-term effects of hydrocortisone." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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