Female RNA Concussion (FeRNAC) study protocol: Assessing Hormone Profiles and Salivary RNA in Females with Concussion by Emergency Departments in New Zealand; a prospective cohort study.

Not Applicable

Recruiting

• Conditions: Concussion; Injuries and Accidents - Other injuries and accidents; Emergency medicine - Other emergency care

• Registration Number: ACTRN12623001129673
• Lead Sponsor: atalie Hardaker

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-02
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

Females of reproductive age – 16-50 years (with a menstrual cycle for a minimum of 2 years).

Natural regular menstrual cycle ~28-35 days long, or
Currently taking Oral Contraceptive Pill (OCP), or
Currently have Intra Uterine Device (IUD), or
Polycystic Ovarian Syndrome (PCOS), or
Oligomenorrheic (irregular periods), or
Amenorrheic (loss of periods for 3 months or longer)

Confirmed diagnosis of concussion by a medical doctor (within last 10 days)

Exclusion Criteria

Had more than three or more previously diagnosed concussions.
Current concussion was more than 10 days ago.
Post-menopause.
Started taking medication that would alter reproductive hormone concentrations (Corticosteroids, e.g., Prednisone. Antidepressant or Antipsychotic medication) within the last 3 months.
Current clinical diagnosis of an eating disorder.
Pre-diagnosed psychiatric disorder.
Pre-diagnosed neurological condition.
GCS score less than 15 at 4 hours after initial assessment. These patients may be referred for a CT scan and will not be eligible for the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified